Clinical

Ocugen, Inc.

Senior Clinical Trial Manager

Description

**Position Summary**

The Senior Clinical Trial Manager (Sr. CTM) is responsible for independently leading the operational management and execution of clinical trials from initiation through close-out. This role focuses on rigorous study execution, proactive risk identification, and strong coordination across clinical, regulatory, biometrics, and external partners.

The Sr. CTM leads complex or high-priority studies with minimal supervision, drives study start-up activities, and maintains strong engagement with investigators and study physicians. This role requires a hands-on, highly organized individual who is comfortable operating in a fast-changing, resource-constrained environment and who can drive execution through vendors, CROs, and internal teams.

**Responsibilities**

**Clinical Execution and Delivery**

- Independently lead the planning, execution, and delivery of clinical studies in accordance with GCP/ICH guidelines, SOPs, and regulatory requirements.
- Drive study timelines, enrollment execution, and operational milestones to meet program objectives.
- Anticipate operational risks and implement mitigation strategies to prevent delays or quality issues.
- Maintain clear visibility into timelines, dependencies, and critical paths across assigned studies.

**Study Start-Up and Site Activation**

- Lead or significantly contribute to study start-up activities including site feasibility, vendor coordination, regulatory package readiness, and site activation timelines.
- Support investigator selection, site qualification, and initiation activities to ensure efficient trial launch.

**Physician and Investigator Engagement**

- Build and maintain effective working relationships with investigators and study physicians.
- Support enrollment strategy, site performance, and investigator engagement to drive study progress.

**Vendor and CRO Oversight**

- Serve as the primary operational contact for CROs and vendors, ensuring performance, timelines, and quality expectations are met.
- Lead vendor governance discussions and hold vendors accountable for deliverables and issue resolution.

**Systems, Documentation, and Inspection Readiness**

- Oversee completeness, quality, and inspection readiness of the eTMF.
- Ensure timely filing and quality control of essential documents within Veeva eTMF and other clinical systems.
- Support audit and inspection readiness activities, ensuring documentation and operational processes meet regulatory expectations.

**Cross-Functional Collaboration**

- Partner closely with Clinical Development, Program Management, Biometrics, Regulatory, QA, and Finance to ensure studies remain aligned with program priorities and milestones.
- Facilitate clear communication and rapid resolution of operational challenges across functions.

**Unblinded Study Responsibilities**

- Serve in an unblinded operational role when required, maintaining strict confidentiality and protocol compliance.

**Budget and Resource Discipline**

- Collaborate with Finance and Clinical leadership to forecast and monitor study budgets.

Identify risks to timelines, resources, or costs early and implement corrective actions.

**Travel**

- Travel to investigator sites, meetings, and vendors as required to support study execution and oversight.

**Continuous Improvement**

- Identify and implement process improvements to enhance study execution, timelines, and operational efficiency.

Qualifications

- Bachelor’s degree in life sciences or related field required; advanced degree a plus.
- Minimum 7–10 years of clinical research experience in biotech or pharmaceutical settings, including experience managing clinical trials.
- Demonstrated experience managing study timelines, vendors, and operational risks.
- Strong knowledge of ICH-GCP, FDA, and international clinical trial regulations.
- Experience with clinical trial systems including CTMS, EDC, and eTMF.
- Experience with Veeva eTMF or comparable document management systems.
- Experience supporting study start-up and site activation activities.
- Demonstrated ability to operate independently, prioritize effectively, and drive execution in a fast-paced, changing environment.
- Strong organizational, communication, and problem-solving skills.

**Preferred**

- Experience in ophthalmology, advanced therapies, or small to mid-size biotech companies.
- Experience working in an unblinded study environment.
- Experience engaging investigators and study physicians directly.

**Working Conditions**

This position operates in an office setting when not traveling on business. Domestic and international travel may be required.

*Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.*

Pennsylvania

Clinical Trial Manager

Description

**Position Summary**

The Clinical Trial Manager (CTM) is responsible for the overall operational management and execution of clinical trials from initiation through close-out. This includes leading the cross-functional study team, managing vendor and site performance, maintaining budget and timelines, and ensuring high-quality data and regulatory compliance. The CTM plays a critical role in driving studies aligned with Ocugen’s development and business strategies.

**Responsibilities**

- Lead the planning, execution, and delivery of clinical studies in accordance with GCP/ICH guidelines, SOPs, and regulatory requirements.
- Own the study operational plan and ensure alignment with the scientific protocol and program goals.
- Manage clinical timelines, enrollment projections, budget tracking, and risk mitigation strategies.
- Serve as the primary point of contact for study vendors (e.g., CROs, central labs, IRT, eCOA) and oversee vendor selection, scope development, contracting, and performance management.
- Oversee internal and external clinical study teams, ensuring training, consistency, and accountability across all trial sites and partners.
- Contribute to the development and review of protocols, amendments, CRFs, ICFs, study reports, and other key documents (e.g., annual reports, IBs).
- Lead site identification, qualification, initiation, and training activities; support Investigator Meetings and site communications.
- Ensure clinical systems (e.g., CTMS, eTMF, EDC) are used effectively and accurately maintained.
- Review proposed trial budgets and site-related expenses, providing approvals as appropriate.
- Collaborate with Finance to forecast and manage study budgets and with Quality to support audit readiness and execution of audit plans.
- Support regulatory submissions and external safety board data reviews as applicable.
- Independently manage LDNA assessments at designated sites and oversee the LDNA coordinator(s); maintain associated SOPs and manuals.
- Identify and implement process improvements to enhance clinical trial execution.
- Serve as a cross-functional liaison between Clinical, Regulatory, QA, Finance, and external partners to ensure execution aligns with company priorities.
- Contribute to the development of clinical publications and scientific communications as needed.
- Perform additional projects and responsibilities as assigned.

Qualifications

- Bachelor’s degree in life sciences or related field required; advanced degree a plus.
- Minimum 5 years of clinical research experience in biotech/pharma, including 2+ years in a Clinical Trial Manager role.
- Experience managing global Phase 1–3 trials and vendor/CRO oversight required.
- Experience in ophthalmology and/or advanced therapy studies are strongly preferred.
- Strong knowledge of ICH-GCP, FDA, and international clinical trial regulations.
- Demonstrated ability to lead cross-functional teams, manage complex studies, and resolve operational challenges.
- Proficiency with clinical trial systems (e.g., CTMS, eTMF, EDC); experience with SAS a plus.
- Excellent written and verbal communication skills; detail-oriented with strong organizational capabilities.
- Self-directed, collaborative, and flexible in a fast-paced environment.

**Working conditions**

This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

*Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.*

In-House Clinical Research Associate

Description

**Purpose**

The **In-House Clinical Research Associate** supports the planning, execution, and closeout of Ocugen clinical studies to ensure study quality, timelines, and regulatory compliance. These activities are performed in accordance with the study protocol, Ocugen standard operating procedures (SOPs), ICH/GCP guidelines, and applicable regulatory requirements.

**Responsibilities**

- Support study start-up, execution, maintenance, and close-out activities for assigned clinical trials.
- Assist with investigator/site identification, feasibility, and recruitment activities.
- Develop and maintain the study document version tracker to ensure document control and version accuracy.
- Upload study documents in the Clinical Trial Management System (CTMS) and Trial Master File (TMF).
- Tracks Investigational Product shipments, returns, destruction and ensures appropriate documentation is filed in the TMF.
- Track and maintain: Subject enrollment, Bioanalytic sample inventory, shipments, and receipt, database queries and resolution.
- Support CRAs and CTMs with study management activities, including vendor oversight, Investigator meeting planning, scheduling study team meetings to include agenda and meeting minutes.
- Coordinate with CRAs to review, maintain, and reconcile essential regulatory and study documents to ensure inspection readiness and compliance with ICH-GCP, SOPs, and applicable regulations.
- Perform routine TMF quality control reviews and coordinate reconciliation activities with field CRAs to ensure inspection readiness and document completeness.
- Supports field CRA(s) and investigational sites with regulatory submissions, IRB/IEC communications, and study-related documentation requirements.
- Serve as a point of contact for investigational sites regarding study questions, documentation, timelines, and operational support as needed.
- Manage and track subject travel reimbursement.
- Coordinate documents for site activation, prepare Investigational Site Green Light form for CTM sign off.
- Assist in the preparation and maintenance of study operational documents, including study plans, monitoring guidelines, site manuals, templates, and training materials.
- Review informed consent forms and essential documents for completeness, quality, and compliance.
- Collaborate with cross-functional teams and vendors to support study deliverables and project goals.
- Identify and escalate study risks, issues, and out-of-scope activities to study manager as appropriate.
- Ensure study activities are conducted in compliance with study protocols, Clinical Management Plans, SOPs, and applicable regulatory requirements.
- Support inspection and audit readiness activities as needed.
- Supports study budget tracking and invoice reconciliation activities as requested
- Perform ongoing eTMF maintenance activities including document filing, QC review, reconciliation, tracking of missing documents, and follow-up with study teams and investigational sites to ensure TMF completeness and inspection readiness.
- Supports preparation and collection of study documentation and data required for safety reviews as applicable
- Proactively identifies risks, developing and implementing mitigation plans as applicable.
- May assist in developing policies and procedures (SOPs).
- Perform additional responsibilities as assigned.

Qualifications

- Excellent communication and collaboration skills with a team-oriented approach.
- Experience with eTMF, CTMS and EDC, (MS Project or Smart sheets timelines desired).
- CRO/vendor management experience is preferred
- Experience in Ophthalmology and/or advanced therapy studies in Phases 1-3 desired.

**Working Conditions**

- This position operates in an office setting, 5 days per week in-person with occasional travel (up to 20%)
- Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

*Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.*

Sanofi US

Medical Science Liaison Rhino Gastroenterology Southwest

Job title: Medical Science Liaison - Rhino - Gastroenterology Southwest

Location: Cambridge, MA.

**About Job**

The **Medical Science Liaison** (MSL) is field-facing role whose main objectives are to:

Be the trusted scientific partner to key external experts by conducting timely, appropriate and frequent scientific exchanges to enhance the understanding of the scientific and medical value of our products.

Execute on stakeholder engagement plans to gather data, develop and share medical insights that contribute to enhancement of Sanofis key medical messages, plans and future research.

Keep abreast of medical and scientific developments in the therapeutic field to help identify and critically assess research opportunities and to play a supportive role in the execution of evidence generation plans to enhance the value of our products in a real-world setting

Recognize, record and share insights that deepen our understanding of the needs of patients, consumers, regulators, payers, and healthcare providers and proactively contributes towards identifying unmet needs.

Maintain effective and appropriate communication among internal stakeholders (Medical Affairs colleagues, Medical Information and Commercial Operations) while maintaining full compliance with relevant company, industry, legal and regulatory requirements

Demonstrate operational understanding and risk management by ensuring excellence in execution of all governance processes.

We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

**About Sanofi**

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines thattreat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

**Main Responsibilities:**

**Engages external stakeholders on medical and scientific information exchange for the therapeutic area during an one-on-one interactions and group settings, exhibiting excellent scientific and clinical knowledge**

Uses strong knowledge of relevant diseases and disease management protocols, healthcare environment and competitors to articulate the medical and scientific value of our products with external experts.

Establishes robust, long-term peer relationships with Key Opinion Leaders and other stakeholder partners

Actively engages with appropriate stakeholders on medical, clinical, epidemiologic, and scientific topics to advance their understanding of the disease by sharing information and answering questions based on approved material within Regulatory guidelines.

Engages with appropriate stakeholders to understand the state of healthcare policies and guidelines as they relate to clinical practices at a local, state, regional, federal, or national level.

Uses defined systems to maps, identify, profile, and prioritizes stakeholders in line with the therapeutic area medical plan and looks for opportunities to collaborate and build a value based partnership addressing the HCPs therapeutic goals.

Effectively utilizes the Scientific Engagement Model to plan territory and individual stakeholder (Key Opinion Leaders, payers, HCP etc.) medical strategy and engagement interaction plans consistent with the Field Base Medical Activity Plan and medical function priorities.

Effectively utilizes the Scientific Engagement Model for attending and establishing a Sanofi Medical presence at relevant scientific congresses, symposia as directed.

Organizes educational meetings or local scientific advisory boards when requested.

Support speakers training to ensure continued scientific support in the field.

Responds to unsolicited request for medical information associated with supported products and disease state area.

**Gathers data and generates insights from stakeholder interactions and provides feedback to the organization**

Recognize and collect feedback/reactions from multiple data sources and various stakeholders.

Record/report insights and information appropriately, using available mechanisms and tools.

Critically and routinely evaluate and discern from the information gained from published studies, and stakeholder interactions to develop key insights that deepen our understanding of the markets needs and opinions of external stakeholders and therefore contribute to enhancement of Sanofis scientific messages, plans, strategy, systems, and product development.

Maintain awareness of and assesses emerging evidence in disease area to educate and enhance discussions with key stakeholders.

**Collaborates effectively with internal stakeholders**

Distribute relevant scientific and medical information and key external insights to internal stakeholders when requested.

Collaborate, as directed, with Commercial Operations, Business Development, Regulatory, etc. to facilitate diligence reviews, medical and safety evaluation, product positioning, lifecycle evidence planning, and compliance needs.

Contribute to the creation of material for internal and external stakeholders where applicable, following internal Sanofi policies, and Federal and National Policies as applicable.

**Supports evidence-generation activities by aiding in data acquisition and identifying opportunities for further data collection clinical or investigator-led**

Monitors disease epidemiology and provides support, including protocol development, when needed on various types of studies: long-term surveillance, compliance, pharmacovigilance, and effectiveness studies

Identifies data collection opportunities during stakeholder interactions and reports these using approved processes.

Maintains awareness of clinical trial activity within territory and suggests clinical trials sites as requested.

Responds to unsolicited requests regarding interest in investigator sponsored studies (ISS), and supports ISS submissions through appropriate internal processes

**Context of the job/major challenges**

Able to operate independently (with minimal supervision) and navigate complex regulatory environments in person and via digital channels from remote (non-office based) environment.

Possible substantial travel: nationally and internationally.

Effectively mediate KOL's complex and controversial opinions vs; corporate policy decisions ensuring KOL relationships/medical strategy are not negatively impacted.

Ensures regulatory boundaries re non-promotional activities are respected vis--vis commercial partners.

**Scope of Role / Outputs**

Manage a base of 50 stakeholders; developing and maintaining stakeholder engagement tracking database.

Territory covers Arizona, New Mexico, Utah, and Southern California region

Plan day-to-day interactions, including discussion points in accordance with Medical Affairs strategy, establishing a frequency of interactions per stakeholder per year to ensure that objectives are met.

Accountability for US KOLs with reporting mainly to Medical Affairs

Executes on defined KOL territory strategy that is targeted to address diverse stakeholder needs (payers, patients, KOLs, HCP etc.) and is aligned with company objectives.

Develops relevant territory engagement plans in line with the medical strategy and supports the teams medical plan execution.

Uses approved scientific data during KOL interactions to advance the understanding of the therapeutic area.

**About You**

**Basic Qualifications**

Advanced degree in a technical, scientific or medical field (MD, PhD, Pharm D,) preferred, or other Relevant Life Science degree (RN/MS) with Rhinology and/or Gastroenterology Specialty required.

Must reside in territory.

Valid drivers license with a clean driving record and ability to pass a complete background check.

Driving a company car in a safe manner to daily meetings and appointments is required.

Responsible for operating the motor vehicle using safe driving practices, knowledge of and compliance with all company policies, and obeying all traffic laws.

**Preferred Qualifications**

Minimum of 2 years of experience in pharmaceutical industry, Medical Science Liaison role, or relevant clinical practice preferred. Additional years of experience are an asset. MSL experience strongly preferred.

Candidates with relevant Immunology clinical experience consisting of Gastroenterology clinical environment may be considered.

Clear understanding of medical practice, clinical decision making, and healthcare systems related to patient care.

Ability to interpret key scientific data and translate this information to meet educational and research needs.

Demonstrated ability to address educational and research needs through delivery of cutting edge scientific/evidenced based data.

Understand the design and execution of research studies.

Exemplary communication and presentation skills.

Experience in working on multi-disciplinary teams and managing significant volume of projects.

Candidates with relevant Immunology clinical experience consisting of Gastroenterology clinical environment may be considered.

**Skills/Knowledge**

Actively listens to others and is adept at confidently stating expert opinion while respecting the positions of others - can exert diplomacy while standing firm on a position.

Utilizes effective, professional communications to cultivate strong working relationships with internal and external colleagues, flexible in own approach to people and situations.

Skillfully plans, prioritizes, and executes multiple responsibilities and projects.

Demonstrates effective leadership skills (by example and through accomplishments), steps forward to handle challenges within scope of authority.

Deep understanding and knowledge of local regulations and codes of practice for pharmaceutical industry, in particular as they apply to the non-promotional activities of this role.

Demonstrates scientific expertise - stays abreast of data, treatment trends, and new information in the profession and ability to articulate therapeutic knowledge and translate expert feedback into appropriate insights.

Knowledge of relevant healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends.

Proficiency in digital tools.

**Why Choose Us?**

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SG

\#LI-GZ

\#LI-Remote

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Massachusetts

Atom Bioscience and Pharmaceutical Co., Ltd.

Sr. Director/VP Clinical Development and Medical Monitoring

**Sr. Director/VP Clinical Development and Medical Monitoring**

Atom Therapeutics is a fast-growing innovative drug company focused on development of best-in-class small molecule therapeutics for treatment of inflammatory and metabolic diseases. The company’s lead product, ABP-671, is in late-stage clinical development for treatment of chronic gout. Another small molecule ABP-745, for anti-inflammatory and autoimmune conditions, has completed Phase 1 clinical trials in the US and demonstrated good pharmacokinetics and safety. A multicounty Phase 2 study with ABP-745 for treatment of acute gout flares is ongoing and a second multicounty study for ASCVD will be starting shortly. We are currently seeking a highly motivated leader to become part of our US clinical development team at Atom Therapeutics. This role will be based in the San Francisco Bay Area. Salary and benefits will be comparable with peers in the biotech industries in USA and China.

**Job Title: Sr. Director/VP Clinical Development and Medical Monitoring**

Department: Clinical Development

Reports To CEO

Base: Newark CA. In office work required.

**Position Purpose:**  
This role will be a strategic leader possessing extensive experience in advancing clinical development and medical monitoring. With a strong medical and science background and an overall expertise in product value chain, the successful candidate should have a close collaboration with and an in-depth understanding of research and commercial functions. With awareness of external innovation competition, a candidate should be able to provide differentiation in clinical strategy to win the market.

**Key Responsibilities**

1. Leads clinical development strategies, including Phase I through III, life cycle management, safety responsibilities, and scientific interactions. Ensures that all clinical trials are in keeping with approved timelines and budgets.

2. Manage the day-to-day activities of the ongoing clinical studies and oversee and coordinate the work of clinical CROs.

3. Track and organize the clinical research developments and data analysis of relevant products that the company is monitoring.

4. Extensive experience dealing with FDA review experts, clinical KOLs, and physician experts. Good understanding of competitive market and unmet needs of the patient to deliver differentiated new products for treatment.

5. Manage clinical medicine, operations, registration, pharmacovigilance (PV), and data statistics-related matters. Organize and coordinate with various departments to ensure timely completion.

**Education**

• Doctor of Medicine degree

**Experience:**

- US Medical license 8+ years of direct experience in Pharma or Biotech with hands on experience in international new drug development. Very proficient in ICH guidelines and FDA requirements.
- 8+ years Director level or above in clinical development with Pharma or biotech.
- Experience working with development of inflammatory and cardiovascular drugs.
- Specific experience leading Phase I, II and III clinical trials on the global level, including a strong experience in managing patient compliance during trials.
- Extensive experience dealing with FDA review experts, clinical KOLs, and physician experts. Good understanding of competitive market and unmet needs of the patient to deliver differentiated new products for treatment.

**Skills:**

- With broader view of the whole process, has in-depth understanding in the scientific field of early research which includes target screening, drug discovery, transfer medical and disease/therapeutic, clinical needs and clinic practices.
- Capable of providing differentiation in clinical strategy in the competition environment.
- Outstanding communication skills when internal facing with CEO and research and commercial team; and when external facing with investors, KOLs and CROs. Good people management skills are a must.
- Strong in actions and know- how in the implementation and execution of responsibilities.
- Good knowledge and understanding of Statistics work.

**Salary Range:**

$250,000 to $375,000 per year, depending on qualifications and experience

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Opportunity Employer

California

Immuneering

Associate Director, Formulations Development (Remote)

**ABOUT IMMUNEERING**

Immuneering Corporation (Nasdaq: IMRX) is a clinical-stage biopharmaceutical company developing oncology therapies using its proprietary Deep Cyclic Inhibition platform. Our lead asset, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK in active Phase 2 and Phase 3 (MAPKeeper 301) clinical trials in pancreatic cancer and RAS-mutant non-small cell lung cancer, as well as additional solid tumor programs. We are committed to delivering transformative treatments to patients with limited options through rigorous science and a collaborative, mission-driven culture.

The Associate Director, Formulation Development will be responsible for overseeing all aspects of Immuneering’s drug product development program, from candidate nomination through the clinical development stage of product lifecycle. This entails the conduct of pre-formulation studies, formulation development, tech transfer, scale-up and manufacturing. This position requires experience in solid oral dosage formulation development, including enabling formulations for poorly soluble (BCS Class II/IV) compounds, and API form characterization and selection. This position also requires a thorough understanding of the principles of quality by design (QbD), and extensive experience in scientific technical writing for drug development and regulatory submissions. Prior experience managing drug product process development and manufacture at CROs and CDMOs is also critical for this position. The successful candidate will be a highly motivated, proactive team player with a strong background in formulation science and process development, and a proven track record of accomplishments. This position will report to the Head of CMC.

**Job Functions and Responsibilities**

• Conduct pre-formulation studies, including API form characterization and selection, in collaboration with Process Chemistry

• Design, execute, and interpret formulation screening and excipient selection studies

• Define phase-appropriate formulation approaches that balance clinical needs, manufacturability, regulatory expectations, and commercial considerations

• Develop innovative, robust, efficient, scalable and cost-effective drug product manufacturing processes

• Act as the main point of contact directing drug product manufacturing process development, technology transfer and manufacturing campaigns at external CDMOs, including development, review and approval of process development protocols, master batch records and manufacturing campaign reports

• Provide person-in-plant support for drug product manufacturing campaigns as required

• Review and approve executed batch records, and provide technical review and approval for quality investigations and batch disposition records

• Assist in establishing critical quality attributes and critical process parameters for drug products in development

• Author or review development reports and risk assessments

• Author assigned CMC sections to support regulatory filings (such as IND, IMPD, NDA, MAA) and respond to questions from regulatory agencies

• Serve as drug product SME for cross-functional project teams

• Collaborate within CMC and across the wider development team to deliver quality drug product for clinical trials within required timelines • Serve as a technical expert and keep current in the field of formulation and process development

• Work in compliance with cGMP, safety and regulatory requirements

• Champion a strong winning culture through the relentless pursuit of excellence, fostering a collaborative and collegial approach to teamwork, and a first-in-class quality organization

**Education, Skills and Qualifications**

**Required:**

• PhD in pharmaceutics, pharmaceutical sciences, chemical engineering, chemistry or related discipline with 8+ years of industry experience; or MS or BS degree in pharmaceutics, pharmaceutical sciences, chemical engineering, chemistry or related discipline with 12+ years of industry experience

• A foundational understanding of pre-formulation studies, formulation design and development and drug product manufacturing process development

• Experience in formulation development of poorly soluble (BCS Class II/IV) compounds (e.g., amorphous solid dispersions (spray-dried dispersions, hot-melt extrusions), lipid-based and self-emulsifying formulations (SEDDS, SMEDDS, lipid suspensions, LNPs, SLNs), micro-encapsulation, micro/nano formulations (nanocrystals, nanosuspensions), salt formulations, co-crystals, etc.)

• Experience in drug product technology transfer and manufacture

• Experience managing CDMOs for research, development and manufacturing campaigns

• Solid understanding of relevant FDA, EMA, and ICH regulatory guidelines as applicable to drug product manufacturing, and current standards of practice in the industry

• Demonstrated ability to apply regulatory guidance to formulate practical solutions and development strategies

• A critical and strategic thinker with exceptional decision-making skills and the ability to work independently in a fast-paced, high-pressure setting

• Excellent technical writing skills; experience with authoring regulatory submissions and responding to regulatory questions

• Values-based leadership and commitment to integrity and ethics in pharmaceutical product development and manufacture

**Preferred**

• Strong theoretical and practical background in relevant pharmaceutical technologies such as dry/wet granulation, extrusion, spray drying, tableting and coating

• Fundamental understanding of physicochemical and biopharmaceutical properties as related to formulation design

• Application of QbD principles to the drug development process, including experience in developing quality target product profiles (QTPPs), defining critical quality attributes (CQAs) and critical material attributes (CMAs), and determining critical process parameters (CPPs) using failure mode and effects analysis (FMEA) and other risk assessment tools • Expertise in pediatric formulation development

• Thorough understanding of analytical techniques used for API form characterization and selection and pre-formulation studies including HPLC, LC-MS, XRPD, DSC, Dissolution, and KF

• Experience in IND/IMPD and NDA/MAA submissions

• Experience in managing quality investigations

• Self-motivated, detail-oriented, with a continuous quality improvement mindset, high personal integrity, and excellent time management and organizational skills

• Excellent communication, problem-solving and organizational skills; thrives in a cross-functional team environment

**Additional Information**

• Travel: 10 to 20%

• Location: Remote

**EQUAL OPPORTUNITY EMPLOYER**

Immuneering Corporation is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

*The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.*

Nationwide

ImmunityBio, Inc

Clinical Trials Manager

**Company Overview**  
ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.  
**Why ImmunityBio?**

• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.

• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.

• Work with a collaborative team with the ability to work across different areas of the company.

• Ability to join a growing company with professional development opportunities.

**Position Summary**

The Clinical Trails Manager is responsible for managing the activities of several clinical studies including assisting in the development of study-related documents, study site management, and patient data monitoring. The role will provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.

**Essential Functions**

- Assist in the development and management of company-sponsored clinical trials
- Assist in reviewing completed assignments by members of the clinical development group
- Assist in the development and management of revisions to study-related documents such as the informed consent, laboratory manual, pharmacy manual, case report forms (CRFs) and other study execution tools.
- Provide support in site recruitment, site initiation, site payments and site close-out.
- Help to oversee the training of new clinical site staff or site training for protocol amendments.
- Liaise with the regulatory department for the collection of updated regulatory documents as needed.
- Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
- Assist in the training of clinical development group staff.
- Prepare and update clinical trial updates for Clinical Development team
- Lead/moderate DSMB teleconferences, monthly PI and Study Coordinator teleconferences.
- Provide support for summarizing and maintaining patient treatment, response and survival data for active studies.
- Performs other duties as assigned.

**Education & Experience**

- Bachelor’s degree in biological science with 5+ years ofrelevant experience in clinical research required

**Knowledge, Skills, & Abilities**

- Proficiency in MS Word, Excel, PowerPoint, Outlook
- Excellent written/oral communication skills as well as strong organizational and multi-tasking skills.
- Understand the job-specific system and processes as defined by the company’s SOPs and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager.
- Maintain corporate confidentiality at all times.

**Working Environment / Physical Environment**

- This position works on site in or remotely depending on the geographic location of the candidate as noted in the offer letter.
- Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
- This position will be exposed to an in-lab environment.
- This position may travel approximately 20% of the time.
- Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
- Lift and carry materials weighing up to 20 pounds.

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

National Market (all markets unless identified as Premium)

$130,000 (entry-level qualifications) to $143,000 (highly experienced) annually

Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston)

$136,500 (entry-level qualifications) to $150,000 (highly experienced) annually

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.

Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.

We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

New York

Clinical Research Associate, In-House

**Company Overview**  
ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.  
**Why ImmunityBio?**

• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.

• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.

• Work with a collaborative team with the ability to work across different areas of the company.

• Ability to join a growing company with professional development opportunities.

**Position Summary**

The Clinical Research Associate, In-House (IH) will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, support for process improvement, collection of essential documents and overall clinical trial support.

**Essential Functions**

- Facilitate study specific inspection readiness initiatives including tracking and maintaining ImmunityBio ClinOps study personnel list and training records
- Support development of new process and system implementations that impact assigned studies and IH team functions
- Identify process inefficiencies, gaps and provide process improvement recommendations to Trial Maintenance leadership
- Support Clinical Trial Manager (CTM) and Clinical Program Manager (CPM) with triage of clinical site inquiries regarding protocol interpretation and eligibility requirements
- Review and update study-related materials track feasibility/start-up activities
- Create regulatory document templates, oversee and support collection of essential documents during site start-up and as needed throughout the study
- Review non-investigational product (non-IP) supply list from the CTM for research sample processing and shipment, review non-IP supply orders forms and work with Supply Chain (SC) for distribution to clinical sites
- File documents to the Trial Master File (TMF) and maintain expected document lists (EDLs) for study and country level documents and provide tracking and/or metrics throughout the study lifecycle as delegated by the CTM
- Communicate regularly with field Clinical Research Associates (CRAs) during site start-up and provide missing document list before the Site Initiation Visit and as needed for subsequent visits
- Review investigational product (IP) metrics to ensure sites maintain sufficient quantities to properly conduct the trial
- File documents to the Trial Master File (TMF) and maintain expected document lists (EDLs) for assigned site documents and provide tracking and/or metrics throughout the study lifecycle
- Perform content review and post approval review of documents filed to the TMF
- Conduct clinical specimen log review, track and coordinate shipment of specimens to the sponsor or contracted supplier
- Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted suppliers
- Support supplier oversight including working with supplier quality group for supplier qualification and new vendor request process with finance and accounting
- Audit Investigator/Site invoices for accuracy and reconcile invoices against the case report forms (CRFs) and budget for payment submission, perform invoice reconciliation at site close-out
- Submit purchase requisitions to Enterprise Resource Planning (ERP) System
- Work with accounting and finance to ensure activated clinical site record is added to the ERP System for site payment processing
- Provide data listings and compile clinical study report documents to support medical writing activities
- Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations
- Support clinical operations safety reporting activities including distribution to sites, tracking, IRB submission and related document filing
- Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities

**Education & Experience**

- Bachelor’s degree with 4+ year experience as a Clinical Trials Associate (or 7+ years’ clinical research experience) required; or
- Associate’s degree with 7+ years’ experience as a Clinical Trials Associate (or 10+ years clinical research experience) required

**Knowledge, Skills, & Abilities**

- Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
- Excellent written/oral communication skills
- Strong organizational and multi-tasking skills
- Maintain corporate confidentiality at all times
- Ability to set priorities and independent decision making
- Ability to work independently as well as in teams

- Anticipate issues, identify process gaps and work to proactively and independently provide solutions

- Independent thinker and persuasive communicator
- Detail oriented, with solid organization and time management skills
- Knowledge of drug development process
- Computer literacy: EDC, eTMF, CTMS, etc.
- Working knowledge of ICH E6, and the Code of Federal Regulations

**Working Environment / Physical Environment**

- This position works on site in Dunkirk, NY.
- Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
- Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
- Lift and carry materials weighing up to 20 pounds.

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

$85,000 (entry-level qualifications) to $93,000 (highly experienced) annually

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.

Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.

We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Veeva Clinical Analyst

**Company Overview**  
ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.  
**Why ImmunityBio?**

• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.

• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.

• Work with a collaborative team with the ability to work across different areas of the company.

• Ability to join a growing company with professional development opportunities.

**Position Summary**

Veeva Clinical Vault Systems Analyst provides foundational technical and operational support for ImmunityBio’s cloud-based Veeva Clinical Vault applications. Working under manager guidance, this role assists in basic system configuration, user access management, and routine troubleshooting. This is an excellent opportunity for someone with a baseline understanding of life sciences software to develop specialized skills in a highly regulated GxP environment.

**Essential Functions**

- Manage day-to-day user administration, including provisioning user accounts, assigning security profiles, and managing permission sets across Clinical Vault applications.
- Assist in executing low-to-medium complexity system configurations, such as modifying picklists, updating document types, and adjusting basic lifecycle states or workflows.
- Create basic reports and Dashboards based upon user provided requirements.
- Monitor the access email inbox, acting as the first line of triage for end-user support. Diagnose access issues, clarify system behavior for users, and escalate complex technical bugs to senior team members or Veeva support.
- Assist in drafting documentation for Computer Software Validation (CSV). Participate in executing User Acceptance Testing (UAT) scripts and documenting results in strict accordance with GxP and 21 CFR Part 11 regulations.
- Support the review process for Veeva’s routine software updates. Assist in testing new platform features in sandbox environments before they are pushed to production.
- Maintain data integrity within the Vault by running routine reports, identifying data entry inconsistencies, and assisting with bulk data uploads or clean-up tasks.

- Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
- Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

**Education & Experience**

- Bachelor’s degree in Information Technology, Computer Science, Bio-Informatics, Life Sciences, or a related field is required.
- 2+ years of experience in an IT support, data coordination, or application management role is required.
- Prior exposure to software systems used in clinical trials, pharmaceutical manufacturing, or regulatory affairs is highly preferred.

**Knowledge, Skills, & Abilities**

- Foundational knowledge or academic exposure to cloud systems. Direct experience using or configuring Veeva Vault applications (such as eTMF, CTMS, CDMS/EDC or RIM) is a major plus but not strictly mandatory if the candidate has strong technical aptitude.
- Understanding GxP validation meaning and a willingness to learn the rigorous documentation standards required in the life sciences industry.
- Familiarity with Excel (for data mapping). Hands-on working knowledge of basic configurations, Veeva security, document types and reports in any of the Veeva vaults.
- Understanding of DIA Reference model, Submissions structures, EDC development principles, Software Development Life Cycle.

- Good communication skills and ability to collaborate with all levels of an organization.
- Ability to adapt quickly, work independently and manage competing priorities.
- Strong attention to detail.
- Strong research & analysis skills, creative thinker who can focus on the details without losing sight of the big picture.

**Working Environment / Physical Environment**

- This position works on site based in Dunkirk, NY.
- Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
- Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
- Lift and carry materials weighing up to 20 pounds

This position is eligible for a discretionary bonus and equity award. The hourly base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

$42.20 (entry-level qualifications) to $47.12 (highly experienced) per hour

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.

Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.

We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Adagene Incorporated

Senior Director, Clinical Development (U.S. Remote)

**About the Company**

Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science.

**Job Summary**

This role is responsible for leading clinical development strategy and execution for immuno-oncology (IO) assets across Phase I–III, serves as Medical Monitor ensuring patient safety and data integrity, drives regulatory interactions (FDA/EMA), and partners cross-functionally to deliver trials on time.

**Key Responsibilities**

- Clinical Strategy & Design: Lead the creation of Clinical Development Plans (CDPs) and design and draft Phase I–III clinical trial protocols for IO assets, ensuring scientific rigor and alignment with corporate goals.
- Medical Monitoring: Serve as the primary Medical Monitor for assigned studies, overseeing patient safety, reviewing SAEs, and providing expert medical judgment on clinical data. Provide expert medical management of Immune-Related Adverse Events (irAEs), such as cytokine release syndrome (CRS) or neurotoxicity, and develop toxicity management guidelines.
- Regulatory Leadership: Act as the lead clinical representative for interactions with health authorities (e.g., FDA, EMA), and author key clinical sections for IND, NDA, and BLA submissions.
- Cross-Functional Collaboration: Partner closely with Clinical Operations, CMC, and Regulatory Affairs to ensure study milestones are met on time and within budget.

**Qualifications & Skills**

- Education: M.D., M.D./Ph.D., with a specialization in Medical Oncology or Hematology/Oncology.
- Experience: 7+ years in clinical development within the biotech or pharmaceutical industry.
- Therapeutic Expertise: Deep knowledge in IO therapies for oncology
- Mindset: Proven ability to thrive in a "player-coach" role within a fast-paced, startup environment.
- Compliance: Expert understanding of GCP, ICH guidelines, and global regulatory requirements.

**Our Benefits and Perks**

- Medical, Dental, Vision
- Life Insurance
- Voluntary Plans
- Vacation
- Sick

**Equal Opportunity Employer**

Adagene is an equal opportunity employer that is committed to diversity and inclusion. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, pregnancy, veteran status, or other legally protected characteristics as outlined by federal, state, or local laws. Learn more about your [EEO Rights](<https://www.eeoc.gov/employers/small-business/employee-rights#:~:text=Employees%20have%20a%20right%20to,(including%20family%20medical%20history).>) as an applicant.

Adagene will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation.

Adagene will consider for employment all qualified applicants with criminal histories in a manner consistent with applicable law. If you are applying for a position in San Francisco, review the [San Francisco Fair Chance Ordinance](<https://sfgov.org/olse/sites/default/files/FCO%20poster2020.pdf>) guidelines applicable in your area.

Adagene participates in the E-Verify program in certain locations as required by law. Learn more about the [E-Verify program](<https://www.e-verify.gov/>).

Adagene is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities. Adagene is a drug-free workplace.