Regulatory

AbbVie

Principal Research Scientist I, Multispecifics Engineering

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

The Multispecifics Engineering group at AbbVie is seeking a highly skilled, self-motivated scientist to join a dynamic team supporting Discovery Biotherapeutics. In this role, the successful candidate will drive the engineering, production, and characterization of multispecific biopharmaceutical products across multiple projects. The ideal candidate has extensive experience in biologics and multispecifics design, with a proven track record of applying multispecific engineering to advance discovery-stage programs, as well as experience in people and project management. We are looking for an enthusiastic, creative scientist ready to make tangible contributions to the pipeline.

**Key responsibilities:**

- Design, engineer, and produce multispecific biologics supporting multiple therapeutic areas.
- Serve as the Multispecifics Engineering representative and subject matter expert on cross-functional teams—including Therapeutic Areas, Discovery Biotherapeutics, and Development Sciences—providing project updates, analysis, and recommendations.
- Serve as Biologics Lead on 1–2 projects, managing molecule-related activities, building timelines with the TA Lead, contributing to key decision-making, and ensuring timely transitions from hit generation through candidate nomination.
- Identify and solve technical problems independently; conceive and implement innovative research ideas that advance the group's and AbbVie's mission.
- Ensure the consistency and quality of technical reports.
- Present original work internally across departments and at internal and external scientific conferences; may author or co-author peer-reviewed papers or patents.

Qualifications

**Minimum Qualifications:**

- PhD or MS degree in Biochemistry, Biochemical Engineering, or a related discipline.
- 6+ (PhD) or 12+ (MS) years of experience in multispecific or antibody engineering
- Experience with the design, expression, and purification of proteins, biologics, fragments, or multispecifics (e.g., bispecifics, trispecifics, bispecific protein fusions).
- In-depth knowledge of the multispecific landscape, including design trends and technologies, and the application of the multispecific modality across therapeutic areas such as immunology, oncology, and neuroscience.
- Ability to recognize emerging areas of interest in multispecific and antibody engineering and related fields, connecting research ideas to build next-generation molecules and advance platforms and programs.
- Excellent organizational skills, with the ability to manage multiple projects simultaneously.
- Strong team player able to operate effectively in a fast-paced, multidisciplinary environment.
- Goal-oriented team player with excellent verbal and written communication skills and a strong can-do attitude.

**Preferred Qualifications:**

- Experience coordinating with CROs for protein production.
- Expert understanding of protein expression, separation, and analytical technologies including mass spectrometry analysis of multispecifics.
- Experience with technologies beyond recombinant protein production for generating multispecifics, enabling high-throughput screening to support agonist programs or screen combinatorial multispecific space (e.g. mammalian display).
- Knowledge of biologic pipeline progression from exploratory through candidate nomination; program management experience preferred.

**Key AbbVie Competencies:**

- Builds strong relationships with peers and cross functionally with partners outside of the team to enable high performance.
- Learns fast, grasps the “essence” and can change the course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.
- Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
- Experience managing direct reports, including performance evaluations and development planning.
- Recognized in the scientific community through a sustained record of peer-reviewed publications and patents.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Massachusetts

GenScript

Research Scientist, Lipid Chemistry

**About GenScript**

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

**Job Summary:**

GenScript has a customized RNA synthesis and delivery formulation service established with good growth opportunity. We are looking for a highly motivated and scientifically rigorous individual to join our Innovation Center for novel lipid or other polymer molecules development to be used in RNA and gene delivery formulation, with experience in developing organic lipid and polymer molecules from R&D to Scale up.

**Duties/Responsibilities:**

- Everyday hand-on chemist willing to get into laboratory to conduct novel organic and lipid polymer chemical synthesis to support and build the company’s proprietary lipid-based drug delivery platform.
- Develop scalable synthetic processes that could eventually lead to commercial use in LNP and targeted LNP formulation.
- Characterize, problem solve and interpret analytical data obtained from instrumentation such as HPLC, LC-MS, NMR etc.
- Maintain Chemistry laboratory and inventories in accordance with good laboratory procedures.
- Communicate regularly with supervisor and peers on research findings and propose suggestions for next steps.
- Maintain a current knowledge of latest technology and scientific trends.
- Perform other duties as needed.

**Required Qualifications:**

- A minimum of a Ph.D. in organic, polymer or lipid chemistry from an accredited University.
- A minimum of 1 year of post-doctoral experience in academia or industry. Experience in a GMP environment is a plus.
- Must have proven track record of scientific accomplishments either in the form of publications or patents.
- Excellent communication and problem-solving skills
- A sense of humility and an eagerness to continue to learn and contribute to a supportive team

**Benefit:**

- Medical Insurance/ Vision Insurance/ Dental Insurance
- 401(k) & Retirement Savings Plan (RSP)
- Short Term Disability Insurance
- New Child Leave
- Paid Time Off
- Paid Company Holidays per year
- Paid Sick Days (earned based on hours worked)
- Compassionate Leave
- Jury Duty Leave
- Float day
- Personal days

**Perks:**

- Free colleague meals during shift
- Onsite massages Charis
- Onsite gyms

**Compensation:**

Salary range: $90,000 – $110,000 total compensation, including bonus, depending on experience and qualifications.

**Benefits:**

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Washington

Dyne Therapeutics

Associate Director, Market Research & Competitive Intelligence

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

The Associate Director, Market Research and Competitive Intelligence generates actionable insights that support global commercial strategy and execution for Dyne’s investigational therapies in Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1). This role partners across global asset and commercial teams and serves as an internal consultant to Marketing, Sales, Market Access, Medical, Clinical, Regulatory, Finance and Advanced Analytics. The role leads primary and secondary market research and competitive intelligence initiatives that anticipate business questions, inform strategic decisions and prepare teams for market-shaping events.

This position is based in Waltham, MA.

**Primary Responsibilities Include:**

*Market Research and Insights*

- Collaborate with global commercial leads to develop, refine and execute insight-generation plans for DMD and DM1 using primary and secondary market research.
- Lead qualitative and quantitative primary market research that builds foundational customer understanding and informs brand and commercial strategy.
- Integrate primary research with secondary data and analytics to translate complex findings into clear, actionable insights and anticipate emerging business questions.
- Manage market research vendor relationships and align project scope, approach, timing and deliverables with business needs.
- Present market research insights and strategic recommendations to senior leaders with clarity, context and strong data storytelling.
- Execute market research projects from initiation through completion in compliance with data governance, privacy, fair market value requirements and applicable external stakeholder engagement policies.

*Competitive Intelligence*

- Partner with Commercial, Program Strategy, Medical, Investor Relations, Corporate Affairs and Business Development to identify priority competitive questions, anticipate market-shaping events and align intelligence to key business decisions.
- Lead the competitive intelligence program for DMD and DM1, assessing market dynamics, product positioning and emerging threats.
- Deliver actionable insights that inform go-to-market strategy, product development and positioning, and create executive-ready briefs for leadership and customer-facing teams.
- Communicate competitive insights, product-planning implications and strategic recommendations through concise, decision-oriented deliverables.
- Design and facilitate competitive scenario-planning sessions and strategic workshops that prepare cross-functional teams for competitor actions, data readouts, regulatory milestones and evolving standards of care.
- Lead congress competitive intelligence planning and execution in collaboration with Commercial, Medical and Scientific Communications.

*Cross-Functional Leadership and Operations*

- Lead multiple insight and intelligence workstreams, establish priorities and coordinate cross-functional resources to deliver high-quality outcomes.
- Build alignment across stakeholders by translating business needs into focused research and intelligence plans.
- Promote scalable, consistent and compliant approaches to insight generation and competitive intelligence across the organization.

**Education and Skills Requirements:**

- Bachelor’s degree required; advanced degree such as an MBA, PhD or PharmD preferred.
- 8+ years of experience in market research and competitive intelligence within biotechnology or pharmaceuticals, in-house or with a vendor.
- Demonstrated expertise designing and executing qualitative and quantitative primary market research and integrating findings with secondary data to shape commercial strategy.
- Experience leading competitive intelligence across a portfolio and communicating implications succinctly to varied audiences; familiarity with practical applications of artificial intelligence in competitive intelligence preferred.
- Experience supporting new product launches and/or rare disease programs preferred.
- Global and U.S. experience preferred.
- Knowledge of regulatory requirements and industry standards related to market research and data analytics in the biotechnology or pharmaceutical sector.
- Exceptional communication, presentation and data-storytelling skills, with the ability to distill complex information into concise, impactful visuals and messages.
- Ability to operate effectively in a fast-paced, dynamic environment while managing multiple priorities.
- Ability to manage and negotiate with external vendors.
- Commitment to the highest standards of professionalism, ethics and integrity.

\#LI-Onsite

MA Pay Range

$185,000 - $215,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*

AGC, Global Commercial Legal - U.S. Market Access and Pricing

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<https://nam12.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.abbvie.com%2F&data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=ouW0EWAXMc6feS9YMhOrX50Xcr7u7esYey2hTi3aXEs%3D&reserved=0>). Follow @abbvie on [X](<https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftwitter.com%2Fabbvie&data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=NB%2BpWyw5752pXI4BpdVAdYgTngw%2FY%2B2lxdjzuU62mik%3D&reserved=0>), [Facebook](<https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.facebook.com%2FAbbVieGlobal%2F&data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=pxrMl8T5PQl8HU8Xhph7jSamZXR%2Fqlh%2FTMIodipTPfs%3D&reserved=0>), [Instagram](<https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.instagram.com%2Fabbvie%2F&data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=NwEPo8j8wQP42UyWxJuNXoHtRJW9IQ8qnjxx6705e8k%3D&reserved=0>), [YouTube](<https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.youtube.com%2Fuser%2FAbbVie&data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=%2Fz0FnNhXfkO2DHSZdZ2mGo6WQ1oEyKQTGDujo0hZDoQ%3D&reserved=0>), [LinkedIn](<https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=eBnFZu5pxx5eG%2F%2BGHQXtjVOLh5olOf3QvjuzpAfYi0E%3D&reserved=0>) and [Tik Tok](<https://www.tiktok.com/@abbvie>).

Job Description

The Associate General Counsel (AGC), Global Commercial Legal - U.S. Market Access and Pricing is responsible for developing legal strategy and support for the Market Access organization, with a substantial focus on payor and trade strategies. The AGC will report to the Senior Associate General Counsel, Global Commercial Legal - U.S. Market Access and Pricing.

This position will provide counsel on a broad range of legal, compliance, and regulatory issues, with a focus on Anti-Kickback Statute, the False Claims Act, FDA regulations, and competition law.

**Responsibilities**

- Serve as business counsel for our Market Access function concerning legal, regulatory, and compliance issues associated with payor and trade access and contracting strategies.
- Advise on Anti-Kickback Statute, False Claims Act, Inflation Reduction Act, and competition law matters, as well as industry guidance (including OIG advisory opinions).
- Provide strategic legal counsel to senior management on product pricing and access matters.
- Prepare, review, and negotiate complex government, payor, and trade agreements.
- Develop deep knowledge of AbbVie’s business and supported client areas, and keeping abreast of changes in law that affect supported client areas.

Qualifications

- Law degree from an ABA accredited law school and in good standing with the state bar of the jurisdiction in which your office will be located (or ability to gain licensure in the state in which your office will be located)
- Minimum of 8+ years of relevant legal experience, with previous pharmaceutical experience preferred.
- Knowledge of commercial payor and trade contracting and the emerging legal and regulatory landscape.
- Comfort taking on high-visibility, high-impact projects with strong communication skills.
- Demonstrated ability to independently identify practical legal solutions to complex and dynamic challenges, and to work effectively in high-pressure, matrixed environments.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at thetime of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of anybonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's soleand absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Illinois

Lundbeck

Senior Manager Regulatory Strategy

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

**Remote/Commuter Opportunity - Open to candidates within the United States**

**SUMMARY:**

The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological products (developmental and marketed products); participates on global cross-functional teams ensuring that US requirements and expectations are achieved in an optimal and compliant manner; ensures compliance with regulatory requirements and corporate standards; maintains candid and positive communications with cross functional partners and operational support.

**ESSENTIAL FUNCTIONS:**

- Provides regulatory review of product documentation intended for regulatory submissions for accuracy and compliance with FDA regulations. Manages, reviews and represents US regulatory perspective at Regulatory Affairs Focus Team (RAFT) meetings. Identifies risk, problem-solves, and offers solutions. Manages/supports related FDA submission activities in compliance with current regulations and guidances.
- Working with US regulatory management and the Global Regulatory Lead, serves as US subject matter expert to support strategy development and execution for assigned products.
- Acts as FDA contact for assigned products. Liaises with regulatory authorities for all drug development and approval aspects.
- Manages the processing of regulatory submissions with Strategy leadership and operational support; ensures submissions are prepared in compliance with regulatory requirements and guidance documents; ensures that appropriate review and approval is obtained.
- Monitors the external regulatory climate to inform internal customers of potential impact on long-term objectives.
- Assists or leads improvement efforts supporting necessary compliance enhancements and departmental efficiencies.
- Manages assembly and creation of documentation supporting investigational and new drug application/biologic license application for the US FDA throughout the product’s lifecycle.
- Provides high-level RA advice and identifies US regulatory requirements for clinical studies and marketing.
- Assesses scientific data for proposed registration and labeling against current FDA guidance’s, regulations, and precedence.
- Facilitates policy and development of standard interpretation of US regulations.
- Maintains awareness of US regulatory legislation and assess its impact on business and Lundbeck product development programs.
- Completes internal and external training on departmental initiatives and for compliance purposes.

**REQUIRED EDUCATION, EXPERIENCE AND SKILLS:**

- Accredited Bachelor’s Degree
- 7+ years within the pharmaceutical and/or biotech industry
- 5+ years direct experience in US Regulatory Affairs
- Direct experience in US drug development and regulatory submissions supporting investigational and marketing application submissions and lifecycle maintenance activities.
- Demonstrated proficiency in following scientific arguments, well-established understanding of scientific data and regulations as they relate to drugs and/or biologics
- Experience in identifying regulatory risk and negotiating/resolving differences
- Attention to detail and strong organizational skills with the ability to meet multiple deadlines and multitask within assigned projects
- Demonstrated ability to work in a multi-disciplinary, matrixed and multinational team
- Excellent oral and written communication skills across all levels of the organization, including ability to articulate regulatory positions
- Ability to successfully prepare and execute regulatory strategies along with providing contingencies and alternate approaches
- Ability to work independently
- High proficiency in MS Word, MS Excel and Adobe Acrobat and regulatory electronic document management system

**PREFERRED EDUCATION, EXPERIENCE AND SKILLS:**

- Accredited Bachelor’s Degree in Science, Chemistry, or Pharmacy
- Advanced Degree in Science, Chemistry, Pharmacy or related subject study/experience
- Experience in Biologic Development
- Familiarity with Chemistry, Manufacturing and Controls requirements
- Strong Preference to be based in Deerfield, IL Office

**TRAVEL:**

- Willingness/Ability to travel ~5% domestically to business meetings and learning experiences.
- If based remotely, additional travel will be required to Deerfield, IL, to meet the needs of the role and the business

The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $165,000 - $185,000 and eligibility for a 15% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site. Applications accepted on an ongoing basis. #LI-LM1, #LI-Remote

**Why Lundbeck**

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the [U.S. career site](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck_Benefits_Summary.pdf>).

*Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the* [*U.S. career site*](<https://www.lundbeck.com/us/careers/your-job/eeo-accommodations-policy>).

*Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in* [*E-Verify*](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/E-Verify_Participation_Poster_Eng_Es.pdf>).

Frederick National Laboratory for Cancer Research

Research Associate I, Histology - Molecular & Digital Pathology Lab, CGR

**Research Associate I, Histology - Molecular & Digital Pathology Lab, CGR**

Job ID: req4713

Employee Type: exempt full-time

Division: Clinical Research Directorate

Facility: Rockville: 9615 MedCtrDr

Location: 9615 Medical Center Drive, Rockville, MD 20850 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

**Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.**

**PROGRAM DESCRIPTION**

The Cancer Genomics Research Laboratory (CGR) investigates the contribution of germline and somatic genetic variation to cancer susceptibility and outcomes in support of the NCI’s Division of Cancer Epidemiology and Genetics (DCEG), the world’s most comprehensive cancer epidemiology research group. CGR is located at the NCI-Shady Grove campus in Rockville, MD and operated by Leidos Biomedical Research, Inc. We care deeply about discovering the genetic and environmental determinants of cancer, and new approaches to cancer prevention, through our contributions to the molecular, genetic and epidemiologic research of the 70+ investigators within DCEG.

Working in concert with epidemiologists, biostatisticians and basic research scientists in DCEG intramural research program, CGR provides the capacity to conduct genome-wide discovery studies and targeted regional approaches to identify the heritable determinants of various forms of cancer. This includes the design and analysis of high throughput studies using various types of “-omics” technologies such as array and sequence-based genome-wide association studies, studies of tumor characteristics using integrated genomic data analysis and molecular epidemiologic studies based on novel assays focused on the metabolome and microbiome.

Within CGR, the Molecular Digital Pathology Laboratory (MDPL) supports the generation of comprehensive data on histological and molecular profiling of tumors and their precursors including histology, various approaches for biomarker analysis, digital pathology and image analysis. This laboratory section is tightly integrated with existing CGR capabilities which include somatic genomic analysis and bioinformatics. We are seeking an enthusiastic and experienced histologist for the Research Associate I position within MDPL.

**KEY ROLES/RESPONSIBILITIES**

- Perform basic histology techniques, including embedding, microtomy, cryotomy, H&E and IHC staining and cover slipping.
- Digitize H&E and IHC/IF slides using a slide scanner.
- Support spatial genomics through use of multiple technologies including Ultivue and Visium HD.
- Perform preventive maintenance on instrumentation in accordance with established SOP’s and vendor guidelines.
- Ensure proper documentation of all experimental and laboratory processes in the Laboratory Information Management System (LIMS), Jira and other tracking systems as required.
- Maintain a safe and efficient laboratory environment and adhere to all laboratory protocols and quality control standards.

**BASIC QUALIFICATIONS**

**To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:**

- Possession of a Bachelor’s degree from an accredited college/university to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical/biochemical research or four (4) years equivalent experience in the appropriate field in lieu of degree. Foreign degrees must be evaluated for U.S equivalency.
- In addition to the education requirement, a minimum of two (2) years related histology laboratory experience.
- Knowledge of basic histological techniques, including tissue processing and embedding, microtomy/cryotomy, H&E staining, slide cover slipping, microscopic recognition of major human tissue types, and QC of unstained and stained slides.
- Experience in chromogenic and fluorescent assay execution on automated staining platforms using human FFPE and frozen tissue sections.
- Proficiency with automated histopathology instrumentation, including microtomes, H&E stainers, slide coverslippers, brightfield and fluorescent microscopes, stereoscopes, and IHC stainers.
- Careful attention to detail. Must be analytical, innovative, and self-motivated.
- Team-oriented with excellent written, verbal communication skills and organizational skills plus the ability to organize and execute multiple projects in parallel both independently and as part of working groups, demonstrated ability to interact effectively with cross-functional teams.
- Ability to be flexible to meet changing needs.

**PREFERRED QUALIFICATIONS**

**Candidates with these desired skills will be given preferential consideration:**

- HT/HTL (ASCP) certification by the American Society for Clinical Pathologists.
- Demonstrated experience with microtomy using both manual and automated methods with archival human FFPE oncology tissue samples.
- Familiarity with Leica BondRX and Roche Ventana for immunohistochemistry staining with both single and multiplex protocols.
- Experience with basic molecular biology techniques, such as RNA, DNA, and protein purification; RNase-free tissue handling of fixed and frozen biological material.
- Working experience with hand macro-dissection of FFPE samples.
- Experience with brightfield and florescence slide scanners (Leica AT2 and Zeiss Axio Scan.Z1).
- Experience with LabVantage LIMS and Jira documentation system.
- Experience with and demonstrated knowledge of proper storage, management, and handling of a diverse collection of FFPE and frozen human biospecimens.
- Strong sense of personal responsibility and ability to work with a team.
- Ability to prioritize, organize, and execute multiple projects.

**JOB HAZARDS**

- This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations.

**Commitment to Non-Discrimination**

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

**Pay and Benefits**

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available [here](<https://frederick.cancer.gov/careers/benefits>)

59,600.00 - 85,400.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

Maryland

Senior Auditor, Compliance Internal Audit

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

AbbVie’s Global Internal Audit function plays a critical role in protecting and enhancing the organization’s value through risk-based assurance and advisory services to internal stakeholders, senior management, and our Audit Committee of the Board.

Internal Audit strives to be a critical function to evaluate company, industry and emerging risks, effectively partnering with the business, and consistently recruit and develop key talent. Our goals are carried-out through the talent of the audit team, while leveraging analytical and audit tools, supported by a dynamic and collaborative team culture.

The scope of compliance audits may include, but is not limited to, the following areas:

• Anti-Bribery / Anti-Corruption

• Promotional / Non-promotional practices

• Third Party Relationships

• Grants & Donations/Research Funding

• Monitoring & Transparency Reporting

• Patient Support Programs

• Contracting / Pricing

• Privacy Laws

Responsibilities

- Internal Audit Key Pillar: Execution
  Our leading pillar is focused on executing our audits and services in accordance with Institute of Internal Audit (IIA) standards, AbbVie Code of Conduct, and other internal policies. We drive meaningful dialogue, analysis, and tools that allow us to partner with our stakeholders on key decisions, aimed at assessing and improving AbbVie’s control environment.
- Internal Audit Key Pillar: Engagement
  We take pride in how we engage with stakeholders and each other – respectfully, ethically, and with AbbVie’s success and our patients at the forefront of our work. We rely on and challenge each other, as peers, knowing that at the core of every successful team is trust, partnership, and respect
- Internal Audit Key Pillar: Development
  The core success of our team is reliant on our talent. We focus on developing members of the audit team to execute audits/services, provide opportunities for training, and upskill other focus areas of each individual. We also continuously assess our culture to allow for an environment that cultivates and sustains an atmosphere of self and team development.
- Planning and executing audits of various processes/locations, both U.S. and international.
- Compile and analyze large sets of data from multiple sources (such as SAP, payroll and various compliance documentation databases).
- Partner with peers in creating a risk assessment analysis of a proposed audit of entities, processes or critical systems.
- Prepare and present audit findings to audit leadership and business stakeholders.
- Identify and communicate risk & control themes to various stakeholders.
- Assist with investigations as requested.
- Demonstrate a high degree of soft/presentation skills.

Qualifications

- At least 3 years of experience with a major public accounting, consulting or law firm in a client-facing capacity
- Bachelor’s Degree.
- Professional certifications/degrees a plus: CIA, CPA, CFE, MBA, JD
- Broad knowledge and experience in FCPA and/or the healthcare industry
- 15 – 35% travel to AbbVie's international and U.S. locations required
- In office/face-to-face interaction at company’s head office and audit locations

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

IDEAYA Biosciences

Director, Intellectual Property

**Non-Solicitation Policy and Notice to Agencies and Recruiters:**

**IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships**. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to humanresources@ideayabio.com. We ask that you only email your interest once.

Job Summary

About IDEAYA Biosciences:

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com.

Location: South San Francisco

Position Summary:

IDEAYA Biosciences is seeking an experienced Intellectual Property (IP) Attorney. Reporting directly to the Vice President of Intellectual Property, this role will support the Company’s intellectual property function to protect the Company’s small molecule product candidates. The ideal candidate will enjoy working collaboratively with inventors across various departments, senior scientific leaders, and the legal team.

This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

Job Description

**What you'll do:**

- Global IP portfolio management, including preparing and prosecuting patent applications focused on small molecules, and developing IP strategy
- Partner with cross-departmental teams to understand project technology, identify patentable inventions, and implement protection strategies
- Identify and evaluate complex risks (e.g., patentability, infringement, validity) and develop business-focused mitigation strategies
- Conduct freedom-to-operate reviews, analyze third-party patent positions, and guide overall IP strategy
- Perform IP due diligence and provide support for business development opportunities
- Manage external legal counsel and ensure compliance with global IP laws and regulations
- Coordinate and manage patent filings and strategy with collaborators and licensors
- Assist in building IP department infrastructure and policies, and provide internal IP training
- Monitor and assess competitive IP landscape and industry trends for risk and opportunity analysis

**Job Requirements:**

- Ph.D. in Chemistry, preferably Organic Chemistry, or Master’s in Organic Chemistry
- Juris Doctorate from an ABA credited law school and a member in good standing of the California Bar, or the ability to qualify as California Registered In-House Counsel
- Registered before the United States Patent and Trademark Office
- Minimum 7 years of experience in providing IP counsel and support in the pharmaceutical small molecules (patent preparation and prosecution, life cycle management, opinion, and IP strategy), including preferably 2-3 years in-house experience
- Proven track record developing and implementing patent strategies with demonstrated success securing meaningful patent protection for products and related technology
- Demonstrated ability to work independently and cooperatively in a fast-paced start up environment with internal teams and to respond in a timely and effective manner
- Must have strong analytical skills and the ability to interpret complex scientific and legal information
- Proficiency in using scientific and IP databases
- Must have excellent written and verbal communication skills and attention to detail

All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct.

Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels

**Total Rewards**

Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

The expected salary range for the roleof Director, Intellectual Property is $261,000- $322,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.

The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.

IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

We are committed to providing reasonable accommodations to qualified individuals with disabilities. If you need assistance or an accommodation due to a disability, please get in touch with us at hr@ideayabio.com.

Contractor Max Bill Rate Per Hour

California

Intellia Therapeutics

Senior Manager, Contracts

**Why Join Intellia?**

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We wantall ofour people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

**How You Will Achieve More:**

We are seeking a Senior Manager of Contracts to join our Legal team. This individual will serve as a key operational and strategic partner for contract drafting, negotiation, execution, and lifecycle management across the company. The ideal candidate is a proactive, highly organized self-starter who thrives in a fast-paced biotech environment and can confidently manage competing priorities.

This role will own the end-to-end contract lifecycle — from intake and drafting through negotiation, execution, and CLM administration — and will serve as a primary point of contact for internal stakeholders across departments including Research, Clinical, Commercial and G&A.

**Responsibilities:**

- Draft, review, and negotiate a wide variety of contracts, including but not limited to confidentiality agreements (CDAs/NDAs) master service agreements (MSAs), statements of work (SOWs), consulting agreements, vendor and supplier agreements, and other commercial contracts.
- Partner directly with internal stakeholders across departments to understand project scopes, objectives, and risk tolerance; translate stakeholder needs into clear, enforceable contract language.
- Identify and flag legal, regulatory, and business risks in contract terms; escalate issues appropriately to senior legal counsel
- Serve as a subject matter expert and administrator for the CLM (Ironclad) platform, including managing templates, workflows, user permissions, reporting, and system enhancements; troubleshoot issues and support user training as needed.
- Manage and continuously improve contracting workflows, processes, reporting, and metrics to drive efficiency, consistency, and scalability.
- Identify opportunities for automation, process enhancement, and operational improvements across the contract lifecycle
- Support ad hoc legal and cross-functional projects as needed.

**About You:**

- Exceptional organizational and time-management skills, with the ability to manage a high volume of contracts and competing deadlines simultaneously.
- Self-motivated, driven, and comfortable working independently with minimal supervision.
- Strong business acumen and the ability to build trusted relationships with stakeholders across all levels and departments.
- Excellent written and verbal communication skills, with the ability to explain contract terms and risks in clear, business-friendly language.
- High attention to detail and strong analytical and problem-solving skills.
- Bachelor's degree required; paralegal certificate, JD, or relevant advanced degree a plus (not required).
- 7+ years of experience in contract management, contract negotiation, or a related legal/commercial function, ideally within the biotech, pharmaceutical, or life sciences industry.
- Hands-on experience administering a Contract Lifecycle Management (CLM); experience configuring workflows, templates, or reporting is a strong plus.
- Prolonged periods of sitting at a desk and working on a computer.

\#LI-Hybrid

**_EEOC Statement:_**  *Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.*

Applications are accepted on a rolling basis, and will continue to be accepted until the position is filled at which point the position will be taken down.

The base salary for this position is expected to range between $146,617.00 - $179,198.00 USD per year.

The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs. Upon joining Intellia, your salary will be reviewed periodically and additional factors such as time in role and performance will be considered. Intellia may change the published salary range based on company and market factors.

Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion.

For more information about Intellia’s benefits, please [click here](<https://www.intelliatx.com/careers/join-us/>).

Amgen

Value & Access Insights Senior Associate

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Value & Access Insights Senior Associate (US Remote)**

**What you will do**

Lets do this. Lets change the world! The Value & Access Senior Associate is a vital member of the US Value and Access Portfolio Coverage & Pricing team responsible for the analysis of federal and state legislative policies impacting Amgen and the biopharmaceutical industry. This role will engage cross-functionally with value and access, finance, government affairs, marketing, legal and other stakeholders to conduct both qualitative and quantitative assessments of policy proposals and enacted legislation. The individual will develop financial models and forecasts to evaluate the potential impact of healthcare policy changes on product pricing, reimbursement, coverage, patient access, revenue, and overall organizational performance.

Key responsibilities include monitoring and assessing emerging federal and state healthcare policy trends; forecasting the financial implications of proposed and enacted legislation; quantifying risks and opportunities associated with policy changes; developing scenario analyses and business impact assessments; and providing data-driven recommendations to support strategic decision-making. The role requires strong analytical and financial acumen, including the ability to synthesize complex policy environments into measurable business outcomes and communicate findings effectively to senior leadership.

This position provides a unique opportunity to develop deep expertise in the U.S. healthcare ecosystem, including reimbursement, coverage, pricing, and healthcare policy. It offers a strong foundation in both access and reimbursement coupled with financial analysis, serving as an excellent pathway to future opportunities across commercial, finance, contracts and pricing, and broader healthcare strategy functions.

**Key job responsibilities:**

- Independently design, prepare and maintain models and analytics to assess impact for various legislations and policies
- Strong financial modeling, forecasting, and scenario-planning capabilities.
- Ability to analyze complex healthcare policies and quantify their financial and operational impact on the organization
- Use forecasts and analytics to support internal and external decision making
- Build and maintain strong relationships with stakeholders; proactively seeks buy-in and provides ongoing support to address business needs
- Constructively challenge teams by providing disconfirming information and encouraging innovative problem solving

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The strategic professional we seek is a collaborative partner with these qualifications.

**Basic Qualifications:**

Masters degree

Or

Bachelors degree and 2 years of policy, finance, consulting and/or analytics experience

Or

Associates degree and 6 years of policy, finance, consulting and/or analytics experience

Or

High school diploma / GED and 8 years of policy, finance, consulting and/or analytics experience

**Preferred Qualifications:**

- 2 years of experience analyzing federal and state policies and legislation that impact the biopharmaceutical industry
- Familiarity with U.S. government pricing concepts and programs, including ASP, AMP, Best Price, Medicaid, and 340B, and their implications for pricing, reimbursement, and access decisions
- Strong proficiency with Microsoft Excel
- Proficiency with building and maintaining complex financial and/or analytical models
- Experience with pharmaceutical/biotech industry
- Familiarity with commonly used biopharmaceutical industry data, including patient, script, claim and government data
- Ability to work on multiple projects and towards multiple deadlines simultaneously
- Willingness to learn and think strategically to support key business decisions
- Strong oral, written and presentation skills; able to explain complex concepts clearly to a variety of audiences including senior leadership teams
- Ability to work collaboratively in teams-based, cross-functional environments

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

District of Columbia

GRAIL Inc

Senior Corporate Counsel, Compliance (Healthcare) #4927

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

GRAIL is headquartered in the Bay Area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.

For more information, please visit [grail.com](<http://grail.com/>)

As Senior Corporate Counsel, Compliance, you will serve as a strategic legal and compliance advisor to leaders across the organization, helping navigate complex healthcare and corporate compliance issues while supporting innovative business initiatives. Reporting to the Chief Compliance Officer, you will help shape and continuously enhance GRAIL's compliance program, influence enterprise-wide initiatives, and foster a culture of integrity, accountability, and ethical decision-making.

This is an exceptional opportunity for an experienced attorney who enjoys solving complex problems, partnering closely with the business, and providing practical, risk-based advice in a dynamic and rapidly evolving healthcare environment.

This role is based in Sunnyvale, California, Washington DC or Durham, NC. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 60% requirement for the site. At one of our campuses on Mondays, Wednesdays, and Thursdays are the key days where we encourage on-site presence to engage in events and on-site activities.

**Responsibilities:**

**Strategic Legal & Compliance Counseling**

- Serve as a trusted legal and compliance advisor to leaders across Commercial, Medical Affairs, Clinical, Finance, Marketing, People, Legal, and other corporate functions.
- Provide practical, business-oriented guidance on healthcare and corporate compliance matters, including the Anti-Kickback Statute,
- False Claims Act, EKRA, anti-bribery and anti-corruption requirements, and other applicable U.S. and international laws and regulations.
- Partner with business leaders to evaluate innovative commercial, medical, and operational initiatives, balancing legal and regulatory requirements with business objectives.
- Advise on healthcare professional (HCP) engagements, consulting arrangements, grants, sponsorships, research support, promotional activities, educational programs, and other business initiatives.
- Review, draft, and negotiate compliance-related provisions in commercial agreements and other business arrangements, as appropriate.

**Compliance Program Leadership**

- Partner with the Chief Compliance Officer to strengthen, scale, and continuously improve GRAIL's global compliance program.
- Lead cross-functional compliance initiatives that enhance governance, operational effectiveness, and accountability across the organization.
- Develop and enhance compliance policies, procedures, guidance documents, and the Code of Conduct to reflect evolving legal requirements and business priorities.
- Design and deliver practical compliance training and communications that empower employees to make informed, ethical decisions.

**Risk Management & Continuous Improvement**

- Lead or support enterprise compliance risk assessments, monitoring, auditing, and investigations, developing practical mitigation strategies for emerging risks.
- Monitor changes in healthcare laws, enforcement priorities, and industry standards, translating regulatory developments into actionable business guidance.
- Drive continuous improvement by identifying opportunities to strengthen compliance processes through technology, automation, analytics, and scalable controls.
- Build strong cross-functional relationships, proactively identify compliance risks, and influence sound business decisions while exercising independent judgment and appropriately escalating novel or significant issues.

*These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.*

**Required Qualifications:**

- Juris Doctor (JD) from an accredited U.S. law school.
- Active membership in good standing with at least one U.S. state bar.Eight (8) or more years of legal and compliance experience within healthcare, biotechnology, diagnostics, pharmaceutical, medical device, or other life sciences organizations.
- Deep knowledge of U.S. healthcare compliance laws, regulations, and industry standards governing interactions with healthcare professionals and healthcare organizations.
- Demonstrated experience advising commercial, clinical, and cross-functional business teams in highly regulated environments.
- Proven ability to independently analyze complex legal and compliance issues and provide practical, risk-based recommendations that enable business objectives while appropriately managing risk.
- Experience developing or enhancing compliance programs, including policies, training, monitoring, auditing, investigations, and enterprise risk assessments.
- Excellent communication, relationship-building, and influencing skills, with the ability to translate complex legal concepts into practical guidance for diverse audiences.
- Strong organizational, analytical, and project management skills, with the ability to manage multiple priorities in a fast-paced environment.

**Preferred Qualifications:**

- Experience supporting diagnostics, precision medicine, oncology, or other innovative healthcare businesses.

- Experience advising on international compliance or anti-corruption matters.
- Experience supporting a publicly traded company.
- Experience leveraging technology, data analytics, or AI-enabled solutions to improve compliance operations.
- Certified in Healthcare Compliance (CHC), Certified Compliance & Ethics Professional (CCEP), or similar certification is a plus.

**Physical Demands & Working Environment:**

- Hybrid work environment consistent with GRAIL workplace practices.
- Occasional domestic travel may be required 10%-15%.

The expected, full-time, annual base pay scale for this position is $235k-$260k (Sunnyvale, CA) or $205k-$226k (Durham, NC or Washington, DC).

At GRAIL, we believe in recognizing and rewarding the contributions our employees make to our mission and success. In addition to base pay, this role may be eligible for additional compensation, including an annual bonus and/or other incentives, in accordance with applicable plans and the company's discretion. The posted range reflects our good-faith estimate of the base pay we expect to offer for this position at the time of hire. Actual compensation will be determined based on factors such as the candidate’s experience, skills, qualifications, and other relevant considerations.

At GRAIL, we invest in the health, well-being, and future of our employees and their families. Employees in this role are eligible for a comprehensive and competitive benefits package designed to support what matters most, including flexible time off or vacation, a 401(k) retirement plan with employer match, medical, dental, and vision coverage, and thoughtfully selected well-being programs. Benefits are offered in accordance with applicable plans and policies.

GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at \[email protected\] if you require an accommodation to apply for an open position.

GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!

Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

North Carolina

Director, Regulatory Affairs - Advertising, Promotional and Labeling #4810

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

GRAIL is headquartered in the Bay Area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.

For more information, please visit [grail.com](<http://grail.com/>)

The **Director, Regulatory Affairs - Advertising, Promotional and Labeling** provides strategic leadership and operational compliance for the company’s product messaging. The Director serves as a senior regulatory subject-matter expert and strategic business partner, who leads cross-functional teams in developing promotional materials to ensure compliance with global regulatory markets, while capturing potential regulatory risks. This role will also partner with executive leadership to guide regulatory strategy for GRAIL’s portfolio and drive business critical decisions.

This is a hybrid role based in Sunnyvale, CA. Our current flexible work arrangement policy requires that a minimum of 40%, or 16 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with the team and business needs and could exceed the 40% requirement for the site.

**Responsibilities:**

- Provide cross-functional leadership and representation for Regulatory Affairs on the Promotional Materials Review Committee, ensuring all promotional materials are compliant with regulatory requirements while shaping and aligning with overarching corporate and portfolio strategies
- Experience leading or supporting product promotion and launches is preferred.
- Define and shape innovative, compliant regulatory strategies and solutions for highly complex and business-critical promotional concepts, enabling business objectives while proactively mitigating regulatory risk across the portfolio
- Lead the oversight and evaluation of product claims to ensure scientifically robust and compliant messaging
- Establish and advance the strategic framework for the advertising and promotion process through developing SOPs to drive continuous improvement, governance, and operational compliance across the organization
- Influence and drive alignment with senior leadership, building consensus and shaping decisions to balance business objectives with regulatory requirements
- Demonstrated ability to lead and foster a culture of continuous learning and process improvement across the organization
- Exceptional communication and influencing skills
- As the organization evolves, the employee must be adaptable to taking on additional responsibilities, new technologies, or cross-functional projects to meet changing business needs

**Adaptability and Growth Expectation**

As our organization continues to evolve and grow, this role may require flexibility in responsibilities and duties. Employees should expect that their role may expand, shift, or be modified to meet changing business needs, strategic priorities, and organizational objectives.

This may include:

- Taking on additional responsibilities.
- Participating in cross functional projects and initiatives.
- Adapting to new technologies, processes, or methodologies.
- Supporting other departments or teams during periods of high demand.
- Contributing to special projects or temporary assignments as needed.

These job duties are a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion.

**Required Qualifications:**

- Advanced degree in molecular biology, genomics, or diagnostics; PhD preferred.
- 15+ years of relevant regulatory affairs or related industry experience; Master's degree with 12+ years, or PhD with 8+ years
- Prior regulatory affairs experience in medical devices, clinical laboratory and/or diagnostics
- Proven record of success leading cross-functional teams to resolve highly complex promotional regulatory challenges, driving innovative, compliant solutions across the portfolio
- Demonstrated level of knowledge of global regulations, guidances, and standards, particularly around advertising and promotion

**Preferred Qualifications:**

- Exceptional leadership skills, with the ability to inspire, align, and influence at all organizational levels.
- Strong strategic foresight with the ability to anticipate regulatory and policy shifts and align company direction.
- Excellent communication, negotiation, and executive presentation skills.
- Proven ability to lead complex programs and drive portfolio-level decision-making.
- Advanced proficiency with regulatory systems, submission tools (e.g., eCTD), and enterprise compliance platforms.
- Commitment to developing talent and building long-term organizational capability.

The expected, full-time, annual base pay scale for this position is $189k-$271k.

At GRAIL, we believe in recognizing and rewarding the contributions our employees make to our mission and success. In addition to base pay, this role may be eligible for additional compensation, including an annual bonus and/or other incentives, in accordance with applicable plans and the company's discretion. The posted range reflects our good-faith estimate of the base pay we expect to offer for this position at the time of hire. Actual compensation will be determined based on factors such as the candidate’s experience, skills, qualifications, and other relevant considerations.

At GRAIL, we invest in the health, well-being, and future of our employees and their families. Employees in this role are eligible for a comprehensive and competitive benefits package designed to support what matters most, including flexible time off or vacation, a 401(k) retirement plan with employer match, medical, dental, and vision coverage, and thoughtfully selected well-being programs. Benefits are offered in accordance with applicable plans and policies.

GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at \[email protected\] if you require an accommodation to apply for an open position.

GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!

Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Vice President, Quality Management Systems and Digital Compliance

**Why Join Intellia?**

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We wantall ofour people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

**How You Will Achieve More:**

The Vice President of Quality Management Systems is responsible for defining and executing the enterprise-wide quality vision that enables organizational growth from clinical development through commercial operations. As a transformational leader and executive sponsor for quality system modernization, this position drives digital transformation through eQMS implementation, establishes robust governance frameworks, and ensures sustained regulatory compliance and inspection readiness. The Vice President of Quality Systems and Digital Compliance will own the strategic vision for data integrity and governance programs including AI/ML quality applications and digital innovation. This role will develop and lead a high-performing quality team focusing on a culture of quality excellence and serve as a strategic partner to executive leadership across R&D, Manufacturing, Regulatory Affairs, and Commercial Operations. This executive role anticipates regulatory trends, manages enterprise risk, and positions quality as a competitive differentiator that directly contributes to business value and organizational success in bringing life-changing therapies to patients.

**Responsibilities:**

Enterprise QMS Strategy & Vision

- Define and execute enterprise-wide QMS strategy aligned with corporate objectives and growth plans
- Serve as executive sponsor for quality system transformation initiatives supporting commercialization readiness
- Lead long-term strategic planning for quality infrastructure investments, technology roadmaps, and organizational capability building
- Anticipate regulatory trends and proactively position the organization to meet evolving compliance requirements
- Champion quality excellence as a competitive differentiator and driver of business value

Organizational Leadership & Transformation

- Lead enterprise-wide quality transformation and change management initiatives, driving cultural change and operational maturity
- Establish governance structures, decision-making frameworks, and accountability models across the quality system
- Build organizational consensus on quality priorities and resource allocation
- Represent Quality in executive forums, strategic planning sessions, and board presentations

QMS Architecture & Implementation

- Design, implement, and scale comprehensive quality systems from clinical through commercial stages, with focus on advanced therapy medicinal products (ATMPs)
- Establish QMS governance framework ensuring compliance with regulatory requirements, industry standards, and company policies
- Own the Quality Management System strategic roadmap with multi-year planning horizons supporting pipeline expansion and future innovations

Quality Systems Management & Governance

- Provide executive oversight for critical quality processes including Deviations, CAPA, Change Control, Document Control, Complaints, Quality Risk Management, and Data Integrity programs
- Chair Quality Management Review processes, presenting system metrics, trends, and strategic recommendations to executive leadership
- Establish quality intelligence and analytics capabilities to drive data-informed decisions
- Drive continuous improvement initiatives and define KPIs that measure quality system performance and business impact

eQMS Implementation & Digital Compliance Leadership

- Lead enterprise digital transformation through adoption, validation, and optimization of electronic Quality Management Systems (eQMS)
- Oversee IT Quality, Computer System Validation (CSV), and Data Integrity programs ensuring compliance with 21 CFR Part 11, Annex 11, and GAMP 5
- Champion strategic vision for Data Governance & Integrity programs, including AI/ML quality applications and digital innovation
- Partner with IT leadership on GxP computer systems lifecycle compliance and drive investment decisions for quality technology stack

Inspection Readiness & Regulatory Compliance

- Ensure enterprise-wide readiness for global regulatory inspections and Pre-Approval Inspections (PAIs)
- Lead critical health authority inspections and third-party GMP audits
- Support regulatory submission strategies and authoring of product licenses and regulatory dossiers

Enterprise Risk Management & Operational Effectiveness

- Establish enterprise risk management framework integrating quality risk into corporate risk management processes
- Define enterprise quality metrics and drive operational effectiveness through data analytics
- Champion quality by design (QbD) and risk-based thinking
- Develop and oversee risk-based approaches for quality system governance
- Ensure proactive identification and mitigation of compliance risks
- Define common global effectiveness and efficiency metrics to drive end-to-end performance
- Implement key performance indicators (KPIs) to monitor QMS effectiveness and enable data-driven decision-making

Team Leadership & Talent Development

- Build, develop, and lead a high-performing organization of quality professionals
- Foster a culture of accountability, innovation, and continuous improvement
- Provide executive coaching and mentorship to quality leaders
- Champion diversity, equity, and inclusion initiatives and drive organizational effectiveness through structure optimization and talent acquisition

Cross-Functional Executive Partnerships

- Serve as strategic partner to R&D, Technical Operations, Supply Chain, Regulatory Affairs, and Commercial Operations leadership
- Collaborate with Legal, Finance, and Corporate Development on compliance risk management, due diligence, and integration activities
- Partner with Human Resources on quality training strategy, organizational design, and change management
- Build external relationships with industry associations, regulatory agencies, and peer organization

Supervisory Responsibilities

- Build, develop, and lead a high-performing organization of quality professionals
- Foster a culture of accountability, innovation, and continuous improvement
- Provide executive coaching and mentorship to quality leaders
- Champion diversity, equity, and inclusion initiatives and drive organizational effectiveness through structure optimization and talent acquisition
- Provides constructive and timely performance evaluations.

**About you:**

- Expert-level knowledge of global health authority regulations including FDA, EMA, PMDA, and ROW requirements for pharmaceuticals and ATMPs
- Deep expertise in ICH guidelines (Q8, Q9, Q10, Q11), 21 CFR Part 11, EU GMP Annex 11, and emerging regulatory frameworks
- Proven expertise leading digital transformation initiatives including eQMS implementation, validation, and optimization
- Strong knowledge of Computer System Validation, data integrity, and digital compliance requirements
- Understanding of quality requirements across multiple product types (biologics, ATMPs) preferred
- Advanced expertise in quality management methodologies including Lean Six Sigma (Black Belt preferred), FMEA, Root Cause Analysis
- Strong proficiency with data analytics, business intelligence tools, and quality metrics dashboards
- Understanding of emerging technologies including AI/ML applications in quality, digital twins, and predictive analytics
- Knowledge of industry risk management concepts and their application to quality management
- BS, MS, or PhD in a field of science, engineering, pharmacy, or medicine.
- 15-20+ years quality leadership in Cell & Gene Therapy, biotech, or pharmaceutical industry with 10+ years managing quality systems and compliance function
- Direct experience leading multiple successful regulatory approvals and commercial launches
- Expert knowledge of FDA, EMA, and global health authority regulations
- Proven track record leading regulatory inspections
- Extensive experience implementing enterprise-wide eQMS and digital transformation initiatives
- Demonstrated success scaling quality organizations from clinical through commercial phases
- Strategic business acumen to translate quality into competitive advantage
- Ability to lead organizational transformation and drive cultural change
- Executive presence with proven ability to influence across all organizational levels
- Experience managing quality teams through high-growth environments
- Deep knowledge of ICH guidelines, 21 CFR Part 11, EU GMP Annex 11
- Strong expertise in data integrity, Computer System Validation, and digital compliance
- Advanced quality methodologies (Lean Six Sigma, FMEA, Root Cause Analysis)
- Experience with emerging technologies (AI/ML in quality, predictive analytics)

\#LI-Remote

**_EEOC Statement:_**  *Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.*

Applications are accepted on a rolling basis, and will continue to be accepted until the position is filled at which point the position will be taken down.

The base salary for this position is expected to range between $319,064.00 - $389,968.00 USD per year.

The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs. Upon joining Intellia, your salary will be reviewed periodically and additional factors such as time in role and performance will be considered. Intellia may change the published salary range based on company and market factors.

Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion.

For more information about Intellia’s benefits, please [click here](<https://www.intelliatx.com/careers/join-us/>).

Senior Manager Corporate Quality Compliance

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Global Quality Compliance, Senior Manager**

**What you will do**

Lets do this. Lets change the world.

Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities:

- Coordinates and leads or participates in Global Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, Critical Service Providers, Suppliers, Partners, and Wholesalers to assess compliance with all applicable regulations and to identify top compliance risks.
- Ensure completion, maintenance, and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to regulations, guidelines and standards, trends and expectations, as applicable).
- Supports preparation of the annual audit plans, as assigned
- Assesses state of compliance with appropriate regulations and participation in the assessment of action plans to correct deficiencies.
- Provides technical and organizational leadership toward resolving site and multi-site compliance issues.
- Alertsexecutivemanagementofsignificantquality,andcompliancerisks.
- Serves as subject matter expert on global regulated requirements and inspectional commitments, as applicable
- Provides support for domestic and international Regulatory Authority Inspections whennecessary.
- Serves as senior Global Quality Compliance representative on cross-functional teams (e.g., QMS, GPO, ALF, and special task forces) and interacts with other departments in order to achieve goals.
- Interactswithotherfunctional area leadstoensurethatAmgenStandards, strategies,anddirectionare alignedwithexistingregulationsandregulatoryexpectations.
- Provides support for audit and inspection metrics, as necessary.
- SupportsContinualImprovementinitiatives,programs,andprojects.
- Owns or performs QA approval for DQMS Quality Event records (Quality Incident, Deviation, CAPA, Change Control, EV for GQC and Audits & Inspections network as required).

**Additional Requirements:**

- Experience with Aseptic Processing, Drug Product, Drug Substance, Combination Products, Data Integrity
- Certified Quality Auditor (CQA) or equivalent
- Travel: Domestic and International Approximately 50%

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

**Basic Qualifications:**

- Doctorate degree and 2 years of auditor experience OR
- Masters degree and 6 years of auditor experience OR
- Bachelors degree and 8 years of auditor experience OR
- Associates degree and 10 years of auditor experience OR
- High school diploma / GED and 12 years of auditor experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- Auditing experience in internal audit, affiliate, CMO, Contract laboratory, Transportation/Logistic/Distribution/ warehouse services,
- 50 % international travel requirement
- Knowledge of international regulations and standards
- Auditing certification preferred
- Detail oriented
- Organizational and multi task skills

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible

**Apply now**

**for a career that defies imagination**

Objects in your future are closer than they appear. Join us.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Senior Associate Paralegal - Trademark (US - Remote)

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Senior Associate Paralegal - Trademark**

**What you will do**

Lets do this. Lets change the world. Join Amgens in-house Trademark, Copyright and Brand Protection Team and play a critical role in protecting and strengthening one of the worlds leading biotechnology brands.

Amgen is seeking an experienced and highly motivated Intellectual Property Trademark Paralegal to support the management, protection, and enforcement of our global trademark portfolio. In addition to trademarks, this position offers the opportunity to work on a broad range of intellectual property matters, including trademarks, domain names, copyrights, brand protection, customs recordations, AI initiatives, and strategic business transactions.

Working closely with in-house attorneys, paralegals, business stakeholders, foreign associates, and outside counsel, the successful candidate will help drive trademark, copyright and domain name strategy and portfolio management while ensuring the timely handling of prosecution, enforcement, and maintenance activities worldwide.

Manage worldwide trademark filings, including prosecution, maintenance, renewals, and communication with business stakeholders.

Prepare and file trademark applications, Madrid Protocol applications, and other trademark prosecution documents with appropriate trademark offices, including gathering and organizing all necessary information.

Communicate directly with foreign associates regarding trademark prosecution and maintenance, and enforcement matters, including opposition and cancellation proceedings.

Review and analyze trademark watch notices and recommend potential enforcement actions.

Coordinate and manage responses to office actions, oppositions, cancellation proceedings, and other trademark disputes, including evidence in support thereof.

Prepare and review affidavits, declarations, powers of attorney, assignments, and related trademark documentation for execution.

Assist attorneys with intellectual property due diligence, mergers and acquisitions, divestitures, and other transactional matters.

Support domain name portfolio management and enforcement activities, including domain name registrations, renewals, transfers, monitoring, Uniform Domain-Name Dispute-Resolution Policy (UDRP) proceedings, and online trademark enforcement through website, marketplace, and social media takedown programs.

Collaborate with Amgens outside vendor on global customs recordation and brand protection initiatives, and supporting international customs enforcement activities with Brand Security.

Maintaining and renewing U.S. Customs trademark recordations in-house.

Maintain accurate trademark records and docket all deadlines associated with correspondence from the USPTO, WIPO, foreign associates, in-house counsel, and outside counsel within Amgens trademark management system.

Serve as a key liaison among attorneys, business clients, foreign counsel, and external service providers to ensure efficient management of trademark matters

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications.

**Basic Qualifications:**

Masters degree

OR

Bachelors degree and 2 years of paralegal/legal assistant program or equivalent experience

OR

Associates degree and 6 years of paralegal/legal assistant program or equivalent experience

OR

High school diploma / GED and 8 years of paralegal/legal assistant program or equivalent experience

**Minimum Qualifications:**

Strong interpersonal, organizational, verbal, and written communication skills.

Motivated self-starter with the ability to work independently and manage multiple priorities in a fast-paced environment.

Familiarity with domestic and international trademark and copyright laws, practices, and procedures.

Knowledge of electronic filing systems, including USPTO and WIPO filing platforms.

Advanced proficiency with Microsoft Office Suite (Word, Excel, PowerPoint), Adobe Acrobat Professional, and DocuSign.

Strong knowledge of electronic document management systems and trademark databases.

Excellent time management skills with the ability to meet competing deadlines and respond promptly to urgent matters.

Exceptional attention to detail and commitment to accuracy.

**Preferred Qualifications:**

Minimum of four (4) years of intellectual property paralegal experience in a law firm, corporate legal department, or equivalent legal environment.

Pharmaceutical, biotechnology, or life sciences industry experience preferred.

Experience preparing and managing Madrid Protocol filings.

Experience with customs recordations and related brand protection activities.

Experience supporting copyright and AI matters.

Experience managing and enforcing domain name portfolios.

Experience undertaking trademark clearance searches using a trademark clearance database and advising business teams on the results thereof.

Experience with the pharmaceutical naming process and management thereof.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

US Regulatory Lead

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**US Regulatory Lead**

**What you will do**

Lets do this. Lets change the world. US Regulatory Affairs provides country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.

The Local Regulatory Representative (Manager) is assigned to one or more Amgen products, and plans and executes the Regulatory strategies for that product(s) in their country(ies). The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen.

Assist in aligning local regulatory requirements with Amgens corporate standards.

Provide local input to and execute regulatory strategies.

Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.

Provide guidance on local mechanisms to optimize product development and regulatory approvals

Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.

Ensure and support local regulatory product compliance (eg, IMR, PMCs, and agency commitments)

Act as the point of contact with regulatory agencies.

Support and provide input into the global regulatory strategy for assigned products, including Global Regulatory Strategic Plans, labeling documents, etc.

**STRATEGIC AND EXECUTION**

Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.

With general supervision, executes the filing plan (MA and Lifecycle maintenance) for their country(ies), where applicable.

Ensures regulatory submissions are made on time and meet Amgens corporate and local regulatory requirements.

Creates, reviews, and approves source text for country labeling, and owns the country artwork based on source text.

Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).

Reviews and approves the promotional and non-promotional materials.

Monitors changes in the local Trade Associations/national legislation and forwards information to local/regional groups communicating the impact to Amgen.

Monitors the external regulatory environment to help inform/advise in the regulatory decision making.

Ensures/supports regulatory product compliance (e.g. IMR, PMCs, pediatric and other agency commitments).

Manages the regulatory submission of urgent safety communications, DHPCs & DILs as required by Amgen SOPs or local regulatory requirements, as needed.

Advises Global teams on local regulatory implications and requirements relevant to the global clinical development/Marketing Applications plans and objectives

As part of the Global Regulatory Team (GRT), provides regulatory direction/expertise on local regulatory mechanisms to optimize product development (eg, expediting studies, Orphan Drug Designations, expedited regulatory designations, compassionate use, and pediatric plans)

**HEALTH AUTHORITY INTERACTIONS**

Acts as the point of contact with regulatory agencies in fulfilling local obligations.

Participates/contributes to local agency interactions and their preparation.

**COMMUNICATION AND COLLABORATION**

Works closely with cross-functional colleagues in the country, Affiliate or Hub to align on strategy and deliver country/Affiliate/Hub goals.

Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.

Partners with International Regulatory Leads (IRLs) and Global Regulatory Leads (GRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.

Partners with peers to ensure consistency on procedures.

Acts as contact and create relationships with Agency staff on specific product assignment (if applicable).

Establishes regular contacts and interactions with Distributors (if applicable).

Provide SME support to process improvement projects/initiatives.

**COUNTRY SPECIFIC ACTIVITIES**

Assists locally in Healthcare Compliance activities where applicable.

Participates in local regulatory process improvements, initiatives and training.

Oversees external vendor/contractor relationships where applicable.

Assists locally in Healthcare Compliance, QA or pharmacovigilance activities where applicable.

**REGULATORY RESEARCH**

Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products

Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement

**MENTORING**

Mentors and/or advises other(s) Local Regulatory Representatives at more junior levels.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

**Basic Qualifications:**

Doctorate degree

OR

Masters degree and 3 years of US Regulatory experience

OR

Bachelors degree and 5 years of US Regulatory experience

OR

Associates degree and 10 years of US Regulatory experience

OR

High school diploma / GED and 12 years US Regulatory

In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- Understanding of drug development.
- Knowledge of Regulatory principles.
- Regulatory submissions experience and experience interacting with regulatory agencies (FDA)
- Working knowledge of U.S. legislation/regulations relating to medicinal products and applicable regulatory principles
- Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
- Knowledge and experience in the US regulatory environment relevant for product area and development stage.

- Demonstrate strong teamwork ability.
- Good communication skills - both oral and written.
- Good negotiation and Influencing skills.
- Ability to understand and communicate scientific/clinical information.
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
- Working with policies, procedures, and SOPs.
- Cultural awareness and sensitivity to achieve results across both regional, country and international borders.

**What you can expect from us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Data Science Sr Director, Research Data Domain Lead

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Data Science Sr Director, Research Data Domain Lead**

**What you will do**

Lets do this. Lets change the world. Amgen is seeking a Data Science Senior Director, Research Data Domain Lead to lead the Research Data Enablement Hub and establish and drive the data strategy for Research. This role is an opportunity for Research to take greater accountability for assigning meaning to our data, making clear choices about its value and use, and driving change toward a more robust, FAIR, AI-ready data ecosystem.

The Research Data Domain Lead will lead matrixed execution of the Research Data Domain Strategy through a network of Subdomain Leads, Data Champions, and Data Stewards, and will lead the Research Data Enablement Hub with the Research Technology Data Co-Lead. The role will partner closely with R&D Tech and Enterprise Data Strategy and Engineering (EDSE), bringing Research priorities, standards, escalations, and strategy together while aligning local accountability and execution with Amgens broader Enterprise Data Strategy.

This is a highly visible leadership role requiring scientific data fluency, strong enterprise and systems thinking, and the ability to build trusted relationships across a complex matrix. The successful candidate will connect people as well as ideas, translate complex Research needs into clear priorities and decisions, and create an environment in which difficult messages and firm prioritizations can be delivered openly, respectfully, and constructively. A positive, can-do attitude and a genuine enjoyment of building authentic networks will be important to success.

**Key Responsibilities:**

**Strategic Data Leadership**

- Lead the Research Data Enablement Hub and own execution of the Research Data Domain Strategy, aligning scientific, business, and enterprise priorities and anticipating future data needs as well as addressing current issues.
- Translate Research and enterprise strategy into a clear Research Data Domain vision, priorities, roadmap, and measurable outcomes, with particular focus on moving Research from fragmented local solutions toward reusable, governed, FAIR data and data products.
- Represent the Research Data Domain in enterprise governance and strategy forums, serving as a strong Research voice and *ex officio* member of the Enterprise Data Council while enabling cross-domain collaboration, interoperability, and data reuse.

**Data Governance, Ownership & Quality**

- Provide accountability for Research domain data assets and data products, setting direction for ownership, governance, usage rules, protection, quality, and lifecycle management. Help Research define what its data means, why it matters, and how it should be used and reused.
- Drive adoption of data governance and stewardship across Research through Subdomain Leads, Data Champions, and Data Stewards, establishing clear accountability, decision rights, and effective governance forums.
- Drive FAIR data maturity and data standard adoption in Research in alignment with the Enterprise Data Strategy, ensuring consistent governance, standardization, and scalability across the domain.
- Ensure that data risks, privacy, security, and regulatory requirements are effectively managed in partnership with the appropriate stakeholders.

**Data Products, AI & Enterprise Value**

- Approve and prioritize the Research Data Domain data product portfolio, promoting reusable, FAIR-aligned, and AI-ready data products.
- Support AI, analytics, and digital transformation initiatives by ensuring the availability of high-quality, governed, and AI-ready Research data.
- Balance trade-offs across scientific value, enterprise reuse, risk, cost, and budget to focus resources on the highest-value outcomes.

**Enterprise Partnership & Decision Leadership**

- Lead and resolve cross-subdomain decisions involving data ownership, priorities, standards, quality, reuse, and investment, escalating enterprise-level decisions where appropriate.
- Partner with R&D Tech, EDSE, and business, privacy, security, and compliance teams to align data investments, resolve cross-domain issues, and ensure that Research needs are translated into practical, scalable capabilities.
- Build alignment across senior stakeholders, make complex choices and trade-offs explicit, deliver clear and sometimes difficult messages with a collegial and welcoming approach, and drive timely decisions with collective accountability for outcomes.

**Organizational Leadership & Change**

- Lead through influence across a matrixed network of Subdomain Leads, Data Champions, and Data Stewards, building strong networks of authentic connectivity and fostering a culture of data ownership, stewardship, and data-driven decision making.
- Drive sustained adoption of new governance routines, standards, and operating behaviors across Research, moving beyond one-time compliance toward durable organizational change and continuous improvement.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

**Basic Qualifications:**

Doctorate degree in a relevant field and 5 years of significant relevant experience

OR

Masters degree in a relevant field and 9 years of significant relevant experience

OR

Bachelors degree in a relevant field and 11 years of significant relevant experience

In addition to meeting at least one of the above requirements, you must have at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- Deep understanding of the drug discovery and preclinical development process.

- Deep understanding of one data types common in Research (ie genetics, biologics, small molecule, assay, etc).

- Broad knowledge of the major data types, data subdomains, and data flows across Research.

- Experience balancing trade-offs across scientific value, enterprise reuse, risk, cost, and budget.

- Scientific data fluency, with the ability to translate between scientific objectives, Research data needs, enterprise reuse, and measurable business value.

- Proven track record of driving sustained adoption and organizational change, translating Research and enterprise strategy into a compelling Research Data Domain vision, priorities, roadmap, and measurable outcomes.

- Demonstrated ability to build trusted relationships and strong networks across organizational boundaries, with an authentic, inclusive, and collaborative leadership style.

- Positive, pragmatic, and action-oriented leadership style, with the resilience and judgment to maintain momentum through ambiguity, competing priorities, and organizational change.

- Demonstrated ability to challenge constructively, deliver difficult messages, and make firm prioritization decisions while maintaining openness, collegiality, and respect.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Inflammation Research - In Vivo Pharmacology Scientist

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Inflammation Research - In Vivo Pharmacology Scientist**

**What you will do**

The Department of Inflammation Research is seeking a dedicated, driven and independent Senior Scientist to join the In Vivo Pharmacology (IVP) group as part of a fast-paced, integrated and interactive research group exploring therapeutics for Inflammation, Autoimmune, and Rare Disease programs. The successful candidate will be responsible for designing and executing experiments exploring and understanding the pharmacology of drug targets; generating, communicating pharmacology and preclinical data to support the progression of research projects, and providing technical expertise to therapeutic area scientists. This role has the potential for managing up to one report initially, contribution to project teams, collaboration with therapeutic area scientists and teams at multiple Amgen sites.

**Who are you**

- PhD degree in immunology, biology, pharmacology or relative disciplines.
- Post-doc or industry experience will be a plus.

- Strong expertise in hands-on expertise in animal (rodent) handling and *in vivo* techniques (i.v., i.p., p.o., i.d., s.c., i.t., bleeds, necropsy) essential.
- Significant experience designing and executing concurrent *in vivo* preclinical inflammation and autoimmune disease models. Experience with colitis, lupus, arthritis, immune modulation (TLR, DTH, Immunization), and respirotoray models preferred..
- Hands-on experience with ex vivo / in vitro cellular, and biochemical assay techniques (i.e. ELISA, MSD, WB, quantitative RT-PCR, tissue protein extraction) is essential.
- Significant experience with multicolor flow cytometry, including Spectral flow approaches and knowledge of and experience working with immune cell populations is essential.
- Experience working in a collaborative team-oriented environment and working on project teams leading in vivo contributions is essential.
- Attention to detail, excellent organizational, time management, and communication skills, accurate & timely record keeping and data analysis are essential.
- Demonstrated track record of independent critical thinking and scientific achievement.
- Computer literacy, especially proficiency with GraphPad Prism, Excel, PowerPoint and Word.

**Key Responsibilities**:

- Design, conduct and lead *in vivo* preclinical model studies and ex vivo analysis independently in collaboration with Inflammation scientists and collaborators.
- Design, execute and data analysis of cutting-edge research and in vivo pharmacology experiments contributing to Amgens Inflammation TA research pipeline.
- Utilize *in vivo* pharmacology and animal models to validate and accelerate molecules through the research pipeline.
- Inform, collaborate, and communicate *in vivo* planning and results with therapeutic area (TA) scientists to align with project goals.

**Basic Qualifications:**

- Doctorate degree
- OR
- Masters degreein immunology or cell biology, or related disciplineand 2 years of industry experience in biotech/pharma
- OR
- Bachelors degreein immunology or cell biology, or related disciplineand 4 years of experience in biotech/pharma

**Preferred Qualifications:**

- Demonstrated track record of independent critical thinking and scientific achievement as exemplified by your publication record and / or significant contribution to a therapeutic program
- Proactive, curious, and eager to learn and contribute to cutting edge science and serve patients in a highly productive team environment.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

**External/Internal postings:**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Internal only posting (or Pre-ID candidate):**

Amgen anticipates accepting applications however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Scientific Associate Director, Human Disease Biology, Inflammation Research

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Scientific Associate Director, Human Disease Biology, Inflammation Research**

**What you will do**

Lets do this. Lets change the world. In this vital role you will work at the intersection of disease biology, multi-omic profiling, computational analysis, and drug discovery, generating insights that advance therapeutic opportunities in respiratory, dermatologic, and/or rheumatologic diseases.

The successful candidate will combine deep expertise in human disease biology with experience translating discoveries into therapeutic hypotheses and drug discovery programs. They will serve as a scientific leader who integrates data across human genetics, transcriptomics, proteomics, spatial biology, and single-cell technologies to identify disease mechanisms, patient subsets, biomarkers, and novel therapeutic opportunities.

Key Responsibilities:

- Develop and execute a disease-focused discovery strategy leveraging multi-omic and human data to deepen mechanistic understanding of respiratory, dermatologic, or rheumatologic diseases.

- Continuous adoption of technology, AI/computation and innovation to improve efficiency and quality of work. Integration of systems immunology, multi-omics, AI-enabled biology, and human disease research to bring unique insights and innovative approaches to Amgen's discovery efforts.

- Lead cross-functional scientific initiatives that integrate human genetics, single-cell biology, spatial biology, proteomics, and computational analyses to identify and validate first/best-in-class therapeutic targets, patient segments and biomarker strategies.

- Drive generation and interpretation of multimodal datasets and translate findings into actionable hypotheses for target discovery and program prioritization/advancement.

- Partner closely with computational biology, translational sciences, human genetics, pathology, and disease-area biology teams to build integrated disease models and prioritize therapeutic opportunities.

- Serve as a scientific leader for disease-focused discovery efforts and provide expertise in human tissue biology, disease pathogenesis, and emerging technologies.

- Design and oversee internal and external collaborations with academic investigators, clinical researchers, consortia, and technology partners.

- Contribute to advancement of programs through target validation, indication selection, biomarker identification, and patient stratification strategies.

- Mentor scientists and foster rigorous, collaborative, and innovative scientific practices across project teams.

- Leads multiple cross-functional projects and scientific initiatives focused on disease understanding and target discovery.

- Influences the direction of several discovery programs through generation of disease insights and translational hypotheses.

- Serves as a recognized expert in disease biology and multi-omic analysis within the department.

- Contributes to departmental strategy related to human biology, disease understanding, and technology deployment.

- Builds productive collaborations across research functions and external scientific communities.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The Associate Director we seek is an accomplished leader with these qualifications.

**Basic Qualifications:**

Doctorate degree PhD

OR

PharmD

OR

MD \[and relevant post-doc where applicable\] and 4 years of relevant scientific experience

OR

Masters degree and 7 years of relevant scientific experience

OR

Bachelors degree and 9 years of relevant scientific experience

**Preferred Qualifications:**

- Significant experience in both academic research and biopharmaceutical drug discovery.
- Experience integrating human genetics, transcriptomics, proteomics, single-cell, spatial, imaging, and clinical datasets to generate actionable biological insights that inform target validation, biomarker strategies, patient stratification approaches, and drug discovery programs.
- Strong understanding of the drug discovery and development process, including target identification, validation, translational strategy, and preclinical development.
- Demonstrated ability to lead matrixed teams and build productive collaborations across scientific disciplines.
- Record of scientific achievement as evidenced by high-impact publications, presentations, patents, external collaborations, or contributions to advancing therapeutic programs.
- Curiosity-driven scientist with a passion for understanding human disease biology and leveraging emerging technologies to accelerate discovery.
- Excellent communication skills and ability to influence scientific strategy across diverse stakeholders.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Director - Oncology Research

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Director Oncology Research**

**What you will do**

Lets do this. Lets change the world. Amgen is a leader in the discovery and development of innovative cancer therapeutics. The Oncology Research team seeks a Director of Research to develop and lead a portfolio of antibody-based therapeutics for solid tumors. In this role, you will work cross-functionally to implement and advance next-generation approaches for cancer therapeutics.

The ideal candidate will have direct experience leading oncology T-cell engager programs from discovery to development candidate nomination, with experience using translational biology approaches to inform clinical development. A deep and broad understanding of cancer cell biology, including human genetics, cell growth signaling pathways, mechanisms of response and resistance, and translational pharmacology will be essential. You will be responsible to lead project teams and external collaborations, as well as to inspire and develop a creative, dedicated research team. You will be an exceptional scientific leader who can translate strategy to execution in a fast-paced, changing matrixed environment. This role has the potential for high visibility within Amgen and externally.

**Key Responsibilities:**

- Lead preclinical research for T cell engager focused on identification of novel target opportunities, prioritization of discovery investments, and implementation of next-generation target discovery approaches.
- Build and lead a portfolio of innovative research programs focused on bispecific antibodies.
- Lead a team of project leaders and lab-based scientists to; create an inclusive high-performing environment that enables new target discovery, rigorous science and efficient execution.
- Lead cross-functional teams and engage key internal partners to integrate tumor biology, target validation, translational research, therapeutic modality considerations, and portfolio strategy.
- Establish productive external scientific collaborations and contribute to evaluation of external opportunities, including business development diligence.
- Partner effectively with peers across research and development to advance new science and integrate technology with tumor cell biology, including application of AI/ML approaches to target and biology evaluation.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

**Basic Qualifications:**

Doctorate degree in Cancer Biology, Cell Biology, Genetics, or related field \[and relevant post-doc where applicable\] and 4 years of directly related experience

OR

Masters degree in Cancer Biology, Cell Biology, Genetics, or related field \[and relevant post-doc where applicable\] and 8 years of directly related experience

OR

Bachelors degree in Cancer Biology, Cell Biology, Genetics, or related field \[and relevant post-doc where applicable\] and 10 years of directly related experience

In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- Doctoral degree in a Cancer Biology, Cell Biology or related field with at least 12 years industry experience following completion of postdoctoral training.
- Demonstrated experience leading drug discovery and development programs through IND/CTA-enabling activities, with strong experience in large-molecule therapeutics and understanding of the preclinical data sets required for development candidate nomination.
- Deep understanding of oncology and tumor biology; expertise in NSCLC or lung cancer biology is strongly preferred.
- Knowledge of antibody engineering approaches, with direct experience designing and evaluating modalities including T-cell engagers and antibody-drug conjugates.
- Established record of building, mentoring, and leading high-performing research teams.
- Exceptional written and verbal communication skills, with the ability to synthesize complex data into clear strategic recommendations.
- Demonstrated scientific impact through publications, patents, invited presentations, or other external recognition.
- Demonstrated ability to use AI/ML to accelerate research and translational biology.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.