Regulatory

Frederick National Laboratory for Cancer Research

Preventative Maintenance & Compliance Specialist (Asset)

**Preventative Maintenance & Compliance Specialist (Asset)**

Job ID: req4699

Employee Type: nonexempt full-time

Division: Facilities, Maintenance & Engineering

Facility: Frederick: Ft Detrick

Location: PO Box B, Frederick, MD 21702 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 Facilities Maintenance and Engineering (FME) Directorate is responsible for laboratory space, administrative space, infrastructure, campus landscape, planning and design, and construction management at Frederick National Laboratory for Cancer Research.

The Preventive Maintenance & Compliance Specialist is responsible for developing, implementing, and managing comprehensive asset identification and tracking programs to ensure the optimal utilization, reliability, and maintenance of all equipment supporting scientific operations, animal welfare, and facility infrastructure across both the Main Campus and the ATRF Campus. This position directly supports the scientific mission by maintaining an accurate and complete inventory of physical assets, coordinating preventive maintenance activities, and ensuring compliance with NCI-Frederick policies as well as all applicable local, state, and federal safety standards.

**KEY ROLES AND RESPONSIBILIES**

- Conduct field surveys of all mechanical spaces to verify that assets are properly identified, clearly labeled, and accurately enter into Maximo.
- In coordination with the PM Maintenance Coordinator, develop, implement, and oversee asset life cycle maintenance programs to minimize downtime and ensure operational continuity.
- Review, input, and update Safety Plans for all assets to ensure compliance with EHS and OSHA policies.
- Maintain and revise Energy Control Procedures (ECPs) for all applicable assets to ensure adherence to safety and regulatory requirements.
- Collaborate with shop supervisors to regularly review and update Job Plans for each preventive maintenance activity, ensuring accuracy and compliance.
- Conduct condition assessments and analyze repair data to make recommendations for utility system upgrades, improvements, or replacements.
- Conducts a comprehensive spare parts inventory by reconciling warehouse inventory with asset materials recorded in Maximo.

**BASIC QUALIFICATIONS**

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

- Possession of a high school diploma or equivalent. Foreign degrees must be evaluated for U.S. equivalency.
- In addition to the education requirement, a minimum of five (5) years of craft/trade-related experience in maintenance, facilities, or asset management is required.
- Ability to frequently lift and carry items weighing up to 25 lbs.
- Must be able to walk, stand for extended periods, climb stairs, bend, stoop, and work in confined spaces and various environmental conditions (dusty, noisy, or outdoor settings).
- Experience using Enterprise Asset Management (EAM) or Computerized Maintenance Management Systems (CMMS).
- Strong analytical, organizational, and communication skills.
- Demonstrated ability to work collaboratively across multidisciplinary teams and manage relationships effectively.
- This position is considered safety sensitive and will be subject to random drug testing per the Leidos Biomedical Research Drug Free Workplace Program.
- Ability to obtain and maintain a security clearance.

**PREFERRED QUALIFICATIONS**

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

- Certification in Asset Management (e.g., IAM, ISO 55000, or equivalent).
- Experience in biomedical research, laboratory operations, or regulated facilities environments.
- Knowledge of complex research equipment, facility systems, and asset tracking technologies.
- Experience with Continuous Improvement and a demonstrated commitment to process optimization, operational efficiency, and best practices in asset lifecycle management.

**JOB HAZARDS**

- This position is subject to working with or has the potential for exposure to animals(s) and/or animal material(s).
- This position is subject to working with or has the potential for exposure to infectious material,
  requiring medical clearance and immunizations.
- This position is subject to working in or have the potential to exposure to high noise levels for
  extended periods of time required medical clearance.

**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>)

55,400.00 - 81,600.00 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

Research Associate II - VICD

**Research Associate II - VICD**

Job ID: req4706

Employee Type: exempt full-time

Division: Vaccine, Immunity and Cancer Directorate

Facility: Frederick: ATRF

Location: 8560 Progress Dr, Frederick, MD 21701 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 Vaccine, Immunity and Cancer Directorate (VICD) at the Frederick National Laboratory investigates immune responses to vaccines in preclinical and clinical studies. The Frederick National Laboratory (FNL) and other stakeholders to develop assays with the highest reproducibility, sensitivity, and specificity for evaluation of immune responses against this new virus. To address gaps and unmet needs in serology assay development and standardization and to gain a solid fundamental knowledge of the immune response to underlying mechanisms of protection against infection, leveraging the vast expertise and excellence in HPV serology at the FNL.

**KEY ROLES/RESPONSIBILITIES**

We are seeking an individual with a strong background in molecular biology and immunology to develop and implement validated immunoassays to be utilized in clinical trial studies. The ideal candidate will have prior experience in cell culture, flowcytometry, neutralization assay, ELISA, PCR, working under Good Clinical Laboratory Practices, with understand of immunology. This position is not eligible for telework and is a 100% onsite position.

Responsibilities include, but are not limited to, the following:

- Perform tissue culture and immunological/virological techniques, including aseptic techniques, cell line maintenance.
- Develop and qualify/validate T cell assays by multi-color flowcytometry.
- Perform serology projects from conception to execution.
- Responsible for sample management and inventory using laboratory information management systems.
- Optimize and validate procedures and methodologies for assessment of immune responses.
- Perform immunoassays and testing of samples from clinical studies.
- Implement protocols, as well as troubleshoot assays and experiments independently.
- Evaluate, analyze and compile data, maintain databases.
- Responsible for routine QC/QA procedures, ordering supplies, and maintaining equipment and inventories.
- Prepare reports, present data and participate in report and proposal preparation.
- SOP development or review and modify SOPs in Master Control and perform validations on processes as required.
- Perform laboratory processes in LIMS.
- Maintain equipment, supply inventory, assist in routine laboratory operation matters.
- Independently troubleshoot assays, processes, laboratory matters and bring to manager’s attention.
- Remain current on literature and relevant laboratory techniques
- Other duties as assigned.

**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 in immunology, vaccinology, or molecular biology from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
- In addition to the education requirement, a minimum of five (5) years of progressively responsible experience in a related biomedical laboratory.
- Detailed knowledge of vaccines, immunology, and virology.
- Expertise in tissue culture and immunological/virological techniques, including aseptic techniques, cell line maintenance, production of plasmids and virus-like particles, western-blot, ELISA, Luminex assays, flow cytometry, virus neutralization assays and PCR.
- Experience in performing T cell functional analyses, using multi-color flowcytometry and other technologies, including panel design, acquisition, and high-dimensional analyses.
- Excellent record keeping and organization skills.
- Excellent communication and presentation skills (written and oral), with proficiency in Word, Excel, PPT.
- Ability to obtain and maintain security clearance.

**PREFERRED QUALIFICATIONS**

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

- Master's or Ph.D. in immunology, vaccinology, virology or molecular biology.
- Experience managing lab operations.
- Experience in immune assay (ELISA, multiplex assays) development and validation under GCLP or GLP environment.
- Experience handling large data sets, statistics, software tools (Word, Excel, PowerPoint).
- Experience in laboratories operating under GCLP/GMP/GLP/CLIA.
- Experience with robotics and automated systems.
- Experience with electronic documentation systems and LIMS.

**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>)

72,200.00 - 103,400.00 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

Supervisor, Research Associate - VICD

**Supervisor, Research Associate - VICD**

Job ID: req4694

Employee Type: exempt full-time

Division: Vaccine, Immunity and Cancer Directorate

Facility: Frederick: ATRF

Location: 8560 Progress Dr, Frederick, MD 21701 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 Vaccine, Immunity and Cancer Directorate (VICD) has a primary mission to provide scientific leadership and laboratory infrastructure to study immune responses to Human Papillomavirus (HPV) vaccines and other cancer preventive strategies in the context of preclinical and clinical studies. As of recent and part of a large effort, the National Institute of Allergy and Infectious Diseases (NIAID) and the Frederick National Laboratory (FNL) and other stakeholders are evaluating vaccines with durable protection for influenza virus. VICD is leading the development of immunoassays with the highest reproducibility, sensitivity, and specificity for evaluation of immune responses against the virus and vaccine.

VICD is recruiting for a Lead, Research Associate to work in a new high impact laboratory that will develop and implement validated immunoassays to be utilized in clinical trial studies, within an internationally recognized research directorate. The ideal candidate will have prior experience working under the Good Clinical Laboratory Practices, with deep understanding of the immunology of influenza viruses or other respiratory viruses, infections and vaccines. This role offers a unique opportunity to shape new scientific directions within a mission-driven environment that integrates new assay development, translational research, and clinical evaluation of new preventive strategies.

**KEY ROLES/RESPONSIBILITIES**

The Vaccine, Immunity, and Cancer Directorate (VICD) is recruiting for a Lead/Supervisor, Research Associate, reporting to the Scientific Manager, assisting with managing a laboratory team and support the development, standardization, and validation of multiple new serology and cellular immunity assays, and conduct sample testing for critical trials. This position is a laboratory position.

- Oversee laboratory projects from conception to execution
- Develop and qualify/validate T cell assays by flowcytometry and Antibody
- Dependent Cytotoxicity Assays
- Responsible for sample management and inventory using laboratory information management systems (LIMS)
- Develop, optimize, and validate procedures and methodologies for assessment of immune responses to infections and vaccines
- Plan experiments and conduct testing of large number of samples from clinical studies, support Scientific Manager in scheduling staff for testing
- Design and implement protocols (literature searches as required), as well as troubleshoot assays and experiments independently and assist laboratory staff to advance the experiments or studies
- Evaluate, analyze and compile data using data analysis software (or other scripts such as R or Python, etc.), and maintain databases
- Responsible for routine QC/QA procedures and maintaining equipment under
- Good Clinical Laboratory Practices
- Manage laboratory supplies and inventory, ensuring minimal impact to workflow
- Prepare reports, present data and participate in report and proposal preparation
- Contribute or write SOPs or protocols in Master Control
- Utilize Laboratory Information Management System (LIMS) for laboratory operation
- Remain current knowledge of emerging relevant scientific literature and immune profiling technologies and laboratory techniques
- Ensures assay rigor, reproducibility, and compliance with GCLP/GLP standards where applicable
- Other duties as assigned

**BASIC QUALIFICATIONS**

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

- Possession of a Master’s degree in Virology, Molecular Biology, Microbiology, particularly in Immunology, or a related field, from in accredited college/university according to the Council for Higher Education Accreditation (CHEA) or six (6) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
- In addition to the education requirement, a minimum of four (4) years of progressively responsible experience, including one (1) years of experience in a leadership/manager capacity of full-time staff
- Deep knowledge of influenza immunology in particular, and viral immunology
- Proven ability to independently design, execute, and troubleshoot complex experiments
- Experience in development, validation and implementation of advanced immunological assays, specifically Multiplex platforms (e.g. Lumines), and including ELISA and antibody-based serological assays, such as for avidity and isotype characterization, using high-throughput immunogenicity testing systems
- Experience in performing T-cell and B-cell epitope mapping and T-cell and B-cell functional analyses, using multi-color flow cytometry and other technologies. Proficiency in multicolor or spectral flow cytometry, including panel design, acquisition, and high-dimensional analysis
- Experience in cellular and molecular biological techniques, including tissue culture, including aseptic techniques, cell line maintenance, production of plasmids and virus-like particles, western-blot, virus neutralizing assays, plaque assays, and PCR
- Flexibility to adopt new emerging techniques and technologies and to troubleshoot effectively
- Ability to work independently and deliver high-quality, consistent results in a timely fashion, prioritize multiple projects effectively and meet timelines successfully
- Experience with managing and analyzing large data sets and ability to understand, interpret, and communicate complex scientific data
- Excellent record keeping and organizational skills
- Exceptional critical thinking and commitment to scientific rigor and reproducibility
- Excellent communication and presentation skills (written and oral), with proficiency in Word, Excel, PPT
- Experience working with LIMS and Master Control (or other electronic documentation system)
- Ability to obtain and maintain security clearance

**PREFERRED QUALIFICATIONS**

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

- Possession of Ph.D. in Virology, Molecular Biology, Microbiology, particularly in Immunology and Virology from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
- Three to five (3-5) years of managerial experience in a GCLP/GLP/GCP laboratory
- Experience supporting immunology components of clinical trials, including multi-omics projects
- Familiarity with integrated immune profiling approaches combining serological, cellular, and molecular data
- Experience with robotics and electronic documentation systems and LIMS
- Familiarity with human research subject requirements and regulations

**JOB HAZARDS**

- Work may involve the use of potentially hazardous chemical or biological materials or may be located in areas where such materials are used
- 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>)

77,600.00 - 113,600.00 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

**Supervisor, Research Associate - VICD**

Job ID: req4693

Employee Type: exempt full-time

Division: Vaccine, Immunity and Cancer Directorate

Facility: Frederick: ATRF

Location: 8560 Progress Dr, Frederick, MD 21701 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 Vaccine, Immunity and Cancer Directorate (VICD) has a primary mission to provide scientific leadership and laboratory infrastructure to study immune responses to Human Papillomavirus (HPV) vaccines and other cancer preventive strategies in the context of preclinical and clinical studies. As of recent and part of a large effort, the National Institute of Allergy and Infectious Diseases (NIAID) and the Frederick National Laboratory (FNL) and other stakeholders are evaluating new vaccines with durable protection for influenza virus. VICD is leading the development of immunoassays with the highest reproducibility, sensitivity, and specificity for evaluation of immune responses against the virus and vaccine.

VICD is recruiting for a Lead, Research Associate to work in a new high impact laboratory that will develop and implement validated immunoassays to be utilized in clinical trial studies, within an internationally recognized research directorate. The ideal candidate will have prior experience working under the Good Clinical Laboratory Practices, with deep understanding of the immunology of influenza viruses or other respiratory viruses, infections and vaccines. This role offers a unique opportunity to shape new scientific directions within a mission-driven environment that integrates new assay development, translational research, and clinical evaluation of new preventive strategies.

**KEY ROLES/RESPONSIBILITIES**

The Vaccine, Immunity, and Cancer Directorate (VICD) is recruiting for a Lead/Supervisor, Research Associate, reporting to the Scientific Manager, assisting with managing a laboratory team and support the development, standardization, and validation of multiple new serology and cellular immunity assays, and conduct sample testing for critical trials. This position is a laboratory position.

- Oversee laboratory projects from conception to execution
- Develop and validate Multiplex based assays by Luminex or other platform and Antibody Dependent Cytotoxicity Assays
- Responsible for sample management and inventory using laboratory information management systems (LIMS)
- Develop, optimize, and validate procedures and methodologies for assessment of immune responses to infections and vaccines
- Plan experiments and conduct testing of large number of samples from clinical studies, support Scientific Manager in scheduling staff for testing
- Design and implement protocols (literature searches as required), as well as troubleshoot assays and experiments independently and assist laboratory staff to advance the experiments or studies
- Evaluate, analyze and compile large sets of data using data analysis software (or other scripts such as R or Python, etc.), and maintain databases
- Responsible for routine QC/QA procedures and maintaining equipment under
- Good Clinical Laboratory Practices
- Manage laboratory supplies and inventory, ensuring minimal impact to workflow
- Prepare reports, present data and participate in report and proposal preparation
- Contribute or write SOPs or protocols in Master Control
- Utilize Laboratory Information Management System (LIMS) for laboratory operation
- Remain current knowledge of emerging relevant scientific literature and immune profiling technologies and laboratory techniques
- Ensures assay rigor, reproducibility, and compliance with GCLP/GLP standards where applicable
- Other duties as assigned

**BASIC QUALIFICATIONS**

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

- Possession of a Master’s degree in Virology, Molecular Biology, Microbiology, particularly in Immunology, or a related field, from in accredited college/university according to the Council for Higher Education Accreditation (CHEA) or six (6) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
- In addition to the education requirement, a minimum of four (4) years of progressively responsible experience, including one (1) years of experience in a leadership/manager capacity of full-time staff
- Deep knowledge of influenza immunology in particular, and viral immunology
- Proven ability to independently design, execute, and troubleshoot complex experiments
- Experience in development, validation and implementation of advanced immunological assays, specifically Multiplex platforms (e.g. Lumines), and including ELISA and antibody-based serological assays, such as for avidity and isotype characterization, using high-throughput immunogenicity testing systems
- Experience in performing T-cell and B-cell epitope mapping and T-cell and B-cell functional analyses, using multi-color flow cytometry and other technologies. Proficiency in multicolor or spectral flow cytometry, including panel design, acquisition, and high-dimensional analysis.
- Experience in cellular and molecular biological techniques, including tissue culture, including aseptic techniques, cell line maintenance, production of plasmids and virus-like particles, western-blot, virus neutralizing assays, plaque assays, and PCR
- Flexibility to adopt new emerging techniques and technologies and to troubleshoot effectively
- Ability to work independently and deliver high-quality, consistent results in a timely fashion, prioritize multiple projects effectively and meet timelines successfully
- Experience with managing and analyzing large data sets and ability to understand, interpret, and communicate complex scientific data
- Excellent record keeping and organizational skills
- Exceptional critical thinking and commitment to scientific rigor and reproducibility
- Excellent communication and presentation skills (written and oral), with proficiency in Word, Excel, PPT
- Experience working with LIMS and Master Control (or other electronic documentation system)
- Ability to obtain and maintain security clearance

**PREFERRED QUALIFICATIONS**

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

- Possession of a Ph.D. in Virology, Molecular Biology, Microbiology
- Three to five (3-5) years of managerial experience in a GCLP/GLP/GCP laboratory
- Experience supporting immunology components of clinical trials, including multi-omics projects
- Familiarity with integrated immune profiling approaches combining serological, cellular, and molecular data
- Experience with robotics and electronic documentation systems and LIMS
- Familiarity with human research subject requirements and regulations

**JOB HAZARDS**

- Work may involve the use of potentially hazardous chemical or biological materials or may be located in areas where such materials are used.
- 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>)

79,500.00 - 113,600.00 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

Syngene International Ltd

Quality Analyst Document Control

**Job Title:** QA Analyst I

**Department:** Quality Assurance

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

*At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.*

**Job Summary:** The QA Analyst I will be responsible for scanning, filing, archiving, organizing, and maintaining an inventory of documents as well as assisting employees in providing assistance for technical writing and formatting documents for consistency, accuracy, and process flow to owners and authors of documents. They are accountable for the execution of daily activities as related to documentation record management, archive, and retrieval of GMP controlled documents ensuring the site complies with relevant regulations. The role will contribute to organizational management on all electronic and paper-based systems that support daily activities of documentation management and proper design.

**Primary Responsibilities:**

- Ensure maintenance of documentation archival and record chain of custody and traceability for onsite and offsite documents for easy identification and retrieval
- Execute daily activities that support documentation compliance and traceability to all executed activities
- Using a systematic approach, scan the contents of various binders and folders into identifiable and properly formatted PDF documents
- Edit the PDF files to ensure that they are bookmarked and linked appropriately
- Perform routine verification to ensure latest documentation archived accordingly
- Achieve and maintain SME status on all functional area application systems and reporting tools for the Electronic Data Management System (EDMS)
- Collaborate with team members and site customers to ensure timely deliverables for documentation and training objectives
- Provide end user assistance/training for document control procedures
- SOP generation and review, providing subject matter expertise to other document authors on site
- Must be capable to work independently and strategically to ensure day¬ to-day activities are carried out in support of the business goals
- Frequently interacts with direct manager, peers, internal customers, and other cross functional peers across Emergent

**Education & Qualifications:**

- Bachelor’s Degree in Scientific or related fields
- A minimum of three (3) years of cGMP in QA documentation in Pharmaceutical industry
- Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.
- The ability to coordinate multiple priorities in a fast-paced environment
- Excellent organizational, analytical and problem-solving skills
- Experience in maintaining CGMP compliance preferred
- Excellent communication skills with the ability to interact with all levels throughout the organization

**Additional requirements for this role:**  Type/keyboard, visual acuity, stand, walk, sit, squat/kneel, sense of hearing, and lift/carry 15 lbs. Use phone, fax, copier and computer. Organize/coordinate, analyse/interpret, problem solve, make decisions, plan, communicate and prepare written communications.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Sanofi US

Senior Manager Regulatory Affairs Advertising and Promotion

**Job title:** Senior Manager Regulatory Affairs Advertising and Promotion

- **Location:** Morristown, NJ/Cambridge, MA

**About the job**

As the Senior Manager, Regulatory Affairs Advertising and Promotionwithin our GRA Advertising and Promo Team, you will be responsible for conducting the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns. Ready to get started?

With some direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches. As the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling, product defense, and development projects. Serve as the primary liaison with FDA, for assigned products, on matters related to advertising and promotional compliance matters.

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

**About Sanofi:**

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

**Main Responsibilities:**

- Identifies product-specific or therapeutic area A&P issues and works with other teams to propose and implement solutions.
- Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound business decisions with the understanding of the potential risk/benefits with respect to intervening regulatory matters.
- Oversees and bears responsibility for the successful implementation of regulatory strategic objectives and projects with minimal supervision.
- Active participant and Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials, respectively.
- Provides guidance and feedback to internal Sanofi constituencies (commercial groups, R&D) to maximize the competitive impact of product development as well as ultimate promotion, advertising, and reimbursement. Provides input to the Global organization on domestic regulatory strategies for in-line products through life cycle management programs.
- Contribute A&P expertise to the development of optimal labeling on new and supplemental new drug applications.
- Provides product-specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders.
- Performs other duties as assigned.

**About You:**

**Basic Education Qualifications:**

- Bachelors degree from an accredited four-year college or university; Science focus preferred but not required.

**Work Experience Required:**

- 3+ Years experience in the within pharmaceutical or medical device advertising and promotional review.
- Successful track record with ideally 1-3 years relevant regulatory experience.
- Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.

**Knowledge, Skills and Equivalent Experience:**

- Knowledge and understanding of complex medical and scientific subject matter.
- Ability to work well within cross-functional teams.
- Demonstrates solid oral communication and writing skills.
- Understanding of the U.S. pharmaceutical marketplace, and familiarity with medical terminology.
- Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
- Develops collaborative relationships to facilitate the accomplishment of work goals.
- Develops and proposes innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
- Shows ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans.
- Can build collaborative internal networks to obtain cooperation.
- Unquestionable ethics, professional integrity and personal values consistent with the Sanofi values.
- Is able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.
- Is able to establish priorities and timelines to effectively manage workload. Is able to multi-task well.
- Deals with people in an honest and forthright manner representing information and data accurately.

**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.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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-Hybrid

\#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>)

New Jersey

**Job title:** Senior Manager, Regulatory Affairs Advertising and Promotion

**Location:** Morristown, NJ/Cambridge, MA

**About the job**

As the Senior Manager, Regulatory Affairs Advertising and Promotionwithin our GRA Advertising and Promo Team, you will be responsible for conducting the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns. Ready to get started?

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

With some direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches. As the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling, product defense, and development projects. Serve as the primary liaison with FDA, for assigned products, on matters related to advertising and promotional compliance matters.

**About Sanofi**

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

**Main Responsibilities:**

- Identifies product-specific or therapeutic area A&P issues and works with other teams to propose and implement solutions.
- Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound business decisions with the understanding of the potential risk/benefits with respect to intervening regulatory matters.
- Oversees and bears responsibility for the successful implementation of regulatory strategic objectives and projects with minimal supervision.
- Active participant and Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials, respectively.
- Provides guidance and feedback to internal Sanofi constituencies (commercial groups, R&D) to maximize the competitive impact of product development as well as ultimate promotion, advertising, and reimbursement. Provides input to the Global organization on domestic regulatory strategies for in-line products through life cycle management programs.
- Contribute A&P expertise to the development of optimal labeling on new and supplemental new drug applications.
- Provides product-specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders.
- Performs other duties as assigned.

**About You**

**Basic Qualifications:**

- Bachelors degree from an accredited four-year college or university; Science focus preferred, but not require

**Work Experience Required:**

- 3+ Years experience within pharmaceutical or medical device advertising and promotional review.
- Successful track record with relevant regulatory experience.
- Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.

**Knowledge, Skills and Equivalent Experience:**

- Knowledge and understanding of complex medical and scientific subject matter.
- Ability to work well within cross-functional teams.
- Demonstrates solid oral communication and writing skills.
- Understanding of the U.S. pharmaceutical marketplace, and familiarity with medical terminology.
- Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
- Develops collaborative relationships to facilitate the accomplishment of work goals.
- Develops and proposes innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
- Shows ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans.
- Can build collaborative internal networks to obtain cooperation.
- Unquestionable ethics, professional integrity and personal values consistent with the Sanofi values.
- Is able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.
- Is able to establish priorities and timelines to effectively manage workload. Is able to multi-task well.
- Deals with people in an honest and forthright manner representing information and data accurately.

**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.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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-SA #LI-SA

\#LI-Hybrid

\#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>)

Senior Clinical Research Director

**Job title**: *Senior Clinical Research Director*

- *Location: Cambridge, MA*

**About the job**

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

Join our Fitusiran Clinical Team as Senior Clinical Research Director, where you will serve as the primary Clinical Lead for the fitusiran registrational development program and ongoing global regulatory submissions. Qfitlia (fitusiran) is a first-in-class antithrombin-lowering therapy approved in the United States and multiple countries for the prophylactic treatment of adults and adolescent patients with hemophilia.

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.

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

**About Sanofi**

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

**Main responsibilities:**

- Develop and implement clinical development plan strategies.
- Lead, support, and oversee the execution of clinical development and study activities.
- Collaborate with functions to ensure a uniform, aligned operational approach. Provide leadership, build consensus, and coordinate action plans with other CRDs and stakeholders to resolve project-related clinical study issues.
- Contribute to the clinical part of submission dossiers for projects, including responsibilities related to regulatory and safety documents and meetings.
- Serve as the medical reference in the team, ensuring the medical relevance of clinical data.
- Lead scientific data evaluation and dissemination.
- Ensures strict compliance with current regulations, laws and HA guidance as well as with Sanofis policies and procedures.
- Foster a collaborative, engaging, and high-performing team environment for Clinical Research Directors and Clinical Scientists.

**About you**

**Minimum Requirements:**

- Medical Doctor or equivalent with specialist training in Hematology, Internal Medicine, Pediatrics, or other relevant specialty
- Minimum 8 years experience

**Basic Qualifications:**

- Strong scientific and clinical background with deep understanding of the therapeutic field
- Expertise in clinical development and methodology of clinical studies
- Understanding of pharmaceutical product development and life cycle management
- Excellent communication, problem solving and decisions making skills for interactions across functional areas and for interactions with key regulatory agencies.
- Strong leadership and collaboration abilities, including the capacity to inspire and guide cross functional teams towards achieving project and team goals.
- English fluent (spoken and written)

**Preferred Qualifications:**

- MD/PhD degree

**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.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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-SA

\#LI-SA

\#vhd

\#LI-Hybrid

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

Assistant General Counsel Policy, Strategy & Litigation

**Job Title**: Assistant General Counsel Policy, Strategy & Litigation

- Location: Washington, DC/Morristown, NJ/Cambridge, MA

**About the Job**

Ready to push the limits of whats possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

This is a senior, high-visibility strategic legal role within Sanofis LEBI organization. The Assistant General Counsel Policy, Strategy & Litigation will help shape how Sanofis Law Division engages the external policy and legal environment that governs how its medicines are priced, purchased, distributed, reimbursed, and accessed. This is not a role that owns a single program it is a role that helps the Law Division think and act strategically across the full landscape of U.S. government pricing and drug pricing reform, including the 340B Drug Pricing Program, PBM reform, Most Favored Nation (MFN) implementation, IRA drug price negotiation, and related federal and state policy developments.

This role reports to the Head of Market Access Legal and will partner closely with the business, the North America General Counsel, the Head of Litigation, the Head of Public Policy & Corporate Affairs, and Communications among others to define Sanofis internal positions, shape affirmative litigation and advocacy strategy, and help design and defend internal programs that advance Sanofis interests and the interests of patients. The role will also maintain day-to-day responsibility for a portion of Sanofis 340B program implementation, providing a concrete operational anchor for the broader strategic mandate. This is a rare opportunity to help build a strategic capability at the center of the Law Division translating legal analysis into positions, programs, and advocacy that shift the external environment in Sanofis favor.

**About Sanofi:**

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

**Main Responsibilities**

*Policy Strategy & Environment Shaping:*

- Help define Sanofis internal legal positions on the drug pricing and government program issues that matter most to the business and the patients it serves including 340B, PBM reform, MFN implementation, and government pricing programs more broadly (Medicaid Drug Rebate Program, Federal Supply Schedule, Medicare Part B/Part D).

- Partner with the Head of Market Access Legal, the North America General Counsel, the Head of Litigation, and the Head of Public Policy & Corporate Affairs among others to develop the Law Divisions environment-shaping strategy identifying where legal, policy, and advocacy tools can be used together to favorably position Sanofis medicines and the broader industry.

- Monitor and analyze federal and state legislative, regulatory, and litigation developments affecting drug pricing, government programs, and access, and translate that analysis into actionable recommendations for senior leadership.

*340B Program Implementation:*

- Serve as day-to-day legal lead on a defined portion of Sanofis 340B program implementation, including aspects of the 340B Integrity Initiative and Credit Model.

- Manage or support 340B HRSA Administrative Dispute Resolution (ADR) proceedings and related federal and state legal matters, in coordination with the Litigation team.

- Maintain current legal positions on key 340B interpretive questions covered entity eligibility, patient definition, contract pharmacy arrangements, orphan drug exclusions, duplicate discounts, and diversion and ensure they are reflected consistently in Sanofis broader policy and litigation strategy.

*Affirmative Litigation & Strategy:*

- Proactively identify, assess, and help develop affirmative litigation and advocacy opportunities that advance Sanofis drug pricing and market access positions.

- Provide litigation strategy counsel across the Law Divisions drug pricing and government program docket, working alongside (not in place of) the attorneys managing individual matters, to ensure litigation positions are coordinated with Sanofis broader policy and advocacy strategy.

- Advise on the litigation risk and strategic implications of policy positions and program design choices before they are adopted.

*Internal Program Design & Defense:*

- Partner with market access legal, market access, and government pricing teams to help design internal programs (e.g., 340B integrity and credit programs, PBM-related initiatives) that are both commercially sound and legally defensible.

- Help build the legal and factual record needed to defend Sanofis programs in litigation, agency proceedings, and public/legislative debate.

*Advocacy & Third-Party Engagement:*

- Serve as Sanofis representative on key trade association working groups (e.g., PhRMA) addressing drug pricing reform, government pricing, and market access policy, representing Sanofis interests and coordinating positions with industry peers.

- Represent Sanofis legal perspective in other industry coalitions and forums on drug pricing reform, government pricing, and market access policy.

- Collaborate with Government Affairs, Public Policy, and Communications to develop and advance Sanofis legislative and regulatory positions, including engagement with Congress, HHS, CMS, HRSA, and relevant state agencies.

- Engage directly with government and regulatory agencies to represent Sanofis legal perspective and advocate for policy outcomes consistent with Sanofis strategy.

*Cross-Functional Partnership & Senior Leadership Counsel:*

- Serve as a trusted strategic advisor to senior Law Division and business leadership, preparing and presenting clear, actionable analysis on high-stakes drug pricing and policy questions.

- Serve as a primary point of contact ensuring legal, policy, and litigation strategies are integrated and coherent across functions rather than developed in silos.

- Prepare and deliver training to commercial, market access, and compliance teams on relevant legal requirements and strategic positioning.

**About You**

**Basic Qualifications**

- J.D. from an ABA-accredited law school; active bar membership in good standing in at least one U.S. jurisdiction.

- Minimum 8 years of experience as a practicing attorney, including substantial experience in complex litigation (through discovery, dispositive motions, and/or trial) and in developing and executing legal or policy strategy at a global company, government agency, trade association, or top law firm.

- Demonstrated ability to master complex, unfamiliar subject matter quickly and to exercise sound judgment before becoming a subject-matter expert.

- Demonstrated strategic thinking, creativity, and sound judgment a track record of shaping positions and strategy, not just executing on settled ones.

- Strong executive presence and communication skills, with the ability to advise and influence senior leaders and to represent the Law Division credibly with external stakeholders.

- Highly collaborative, with the interpersonal skill to build trust and alignment across legal, business, and policy functions.

*Preferred Qualifications:*

- Working knowledge of the 340B Drug Pricing Program and other federal government pricing programs (Medicaid Drug Rebate Program, Federal Supply Schedule, Medicare Part B/Part D), including familiarity with Best Price, AMP, and ceiling price concepts. Direct 340B experience (contract pharmacy, duplicate discounts, diversion, HRSA ADR proceedings) is a plus given this roles ongoing operational 340B responsibilities but is not required at hire.

- Experience with, or working knowledge of, PBM reform, Most Favored Nation (MFN) policy, Inflation Reduction Act (IRA) drug price negotiation, or related drug pricing reform issues.

- Experience litigating constitutional claims, statutory and regulatory challenges, and/or Administrative Procedure Act (APA) matters.

- Experience engaging with trade associations, government agencies, and/or state attorneys general on policy or litigation matters.

- A federal appellate clerkship or comparable litigation pedigree.

- Enthusiasm for using AI and emerging technology to work more effectively.

**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.
- Make your work count by supporting a company that brings life-changing treatments to millions and is committed to doing right by patients, communities, and the planet.
- Drive progress from within by helping simplify, scale, and modernize how a global biopharma business delivers smarter, faster, and more sustainably
- Support teams across science, medicine, and operations by building better systems, shaping bold strategies, and enabling innovation at speed

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-SA

\#LI-SA

\#vhd

\#LI-Hybrid

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>)

District of Columbia

**Job Title:** Senior Clinical Research Director

**Location:** Cambridge, MA

**About the Job**

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

We are looking for a Senior Clinical Research & Development (CRD) to join our Rheumatology/Transplant clinical development team, playing a pivotal leadership role in shaping and advancing our clinical programs. If you are a medically trained expert with a passion for immunoscience and a drive to mentor, collaborate, and innovate, this is your opportunity to make a meaningful impact at scale.

**About Sanofi**

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

**Main Responsibilities:**

The Senior CRD serves as a senior medical and scientific leader within the Rheumatology/Transplant team. Key responsibilities include:

**Leadership & Mentorship**

- Act as a mentor for other CRDs and Clinical Scientists within the same project or therapeutic area
- Provide leadership, build consensus, and coordinate action plans with other CRDs and stakeholders to resolve project-related study issues
- Anticipate potential issues by sharing lessons learned across project and study teams
- Raise study or project-level issues to TA Heads as relevant, and share pertinent information within and beyond project teams

**Cross-Functional Collaboration**

- Collaborate with functions to ensure a uniform, aligned operational approach (e.g., harmonizing study documents, endpoints, protocols)
- Interact with other CRDs in the project, Global Project Head, PV Representatives, Regulatory, and other key functional representatives

**Clinical Research & Development (CRD Role)**

- Provide medical expertise to clinical studies (except select Exploratory Pharmacology studies) and/or registries, including protocol development, Key Results, and Clinical Study Reports
- Support other clinical development activities such as pressure testing and cluster feasibility, medical review and validation of clinical data, and study risk assessment
- Contribute to the clinical part of submission dossiers, including Common Technical Documents for FDA & EMA submissions, filings in Japan and China, and responses to health authority questions
- Provide appropriate medical input and support for all activities related to clinical studies, including medical training, feasibility assessments, medical review of data, and medical information for study teams, medical advisors, Clinical Project Leaders from Clinical Study Units, and investigators
- Serve as the medical reference within the Clinical Study team, ensuring the medical relevance and integrity of clinical data

**About You:**

**Experience & Competencies:**

- Understanding of pharmaceutical product development and life cycle management gained through approximately 4 years of clinical development and medical experience
- Excellent scientific and medical/clinical expertise
- Excellent expertise in clinical development methodology and design of clinical studies
- Excellent communication skills (verbal and written) for interactions across functional areas and with key regulatory agencies
- Demonstrated capability to challenge decisions and the status quo with a risk-management approach
- Ability to negotiate to ensure operational resources are available for continued clinical conduct
- Fluency in written and spoken English
- Excellent teaching skills with a demonstrated ability to assist and train others
- Ability to work effectively within a matrix model
- Strong international/intercultural working skills
- Open-minded and adaptable to new digital solutions

**Qualifications:**

- MD or equivalent medical degree is required (DO, MBBS)
- Medical training or clinical development experience in rheumatology, hematology, transplant, or immunology
- At least 4 years in the pharmaceutical industry (experience in late-stage clinical development preferred)
- English fluency (spoken and written)

**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 a 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 US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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-SA

\#LI-SA

\#LI-Hybrid

\#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>)

Patient Privacy Officer & Counsel

**Job title:** Patient Privacy Officer & Counsel

**Location:** Morristown, NJ / Cambridge, MA

**About the job**

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Privacy team as a Patient Privacy Officer to shape the Sanofi Privacy strategy towards Patients, preventing risks to materialize, protecting Patients fundamental rights whilst enabling trustworthy innovation .

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

**About Sanofi**

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

**Main responsibilities:**

In this role you will act as a global officer and expert on Data Privacy, promote and maintain a culture of privacy at every stage of the patients data life cycle, mastering TRT (Thoughtful Risk Taking) and a Patient centric approach

- As the business partner for several R&D and/or Medical departments, you will have end-to-end accountability to drive all privacy activities within your area, from driving privacy-by-Design of new projects to the effective monitoring and reporting of the risk management strategies to senior R&D leaders.
- As a Subject Matter Expert of patient data, you will drive transversal privacy initiatives to foster responsible use of patient data, informed by patient perspectives, ethical and regulatory standards, and cross-functional alignment to protect patient rights and maintain trust while enabling innovation
- You will monitor privacy risks in your area
- You will partner with the local Privacy Officers and Legal teams in ensuring the Global Patients initiatives you support are compliant with local practices and regulations, and offering local resolutions,
- You will co-author internal position papers with Legal, R&D and Government Affairs, representing Sanofi in industry advocacy efforts with Trade associations, Patient Associations Groups and Data Protection Regulators;
- You will oversee patients rights requests coming from your respective areas, ensuring patients rights are upheld in line with regulatory requirements and Sanofis commitments to privacy;
- You will drive the effective closure of action plans originating from regulatory inspections and internal audits

**About you**

**Qualifications:**

- Juris Doctorate (JD) degree from an accredited law school, (or an equivalent advanced degree in law) and a valid license to practice law in the US
- Minimum of 7 years of professional experience, including significant experience in data privacy
- In depth knowledge of U.S. State and federal privacy laws/regulations: California Consumer Privacy Act, Health Insurance Portability and Accountability Act, familiarity with AI regulations and ethical frameworks
- Relevant privacy certification: CIPP/US, CIPP/E, CIPM or equivalent is preferred
- Excellent understanding and working experience of the R&D journey of a new drug from the definition of the drug candidate to product registration and safety, in a regulated research and development setting (i.e. subject to Good Clinical Practices)
- Demonstrated experience in applying privacy principles and regulations in Research and Development, additional experience in patient programs if a plus
- Proven crisis leadership with strong accountability, and the ability to navigate tensions, align stakeholders, and drive coordinated action toward resolution.
- Solid communication skills and stakeholder management to establish credibility and drive decision making with senior internal stakeholders, balancing authority (executive presence) with solutions orientation.
- Advanced advocacy skills with external stakeholders (regulators and industry peers) to influence future regulations and shape Healthcare ecosystem.
- Ability to translate how the regulatory, societal and technological changes in biomedical research are impacting the patient privacy risk profile to proactively identify long term risk mitigations and opportunity strategies.

**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 US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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-SA

\#LI-SA

\#LI-Onsite

\#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>)

Daiichi Sankyo

Director, Global Regulatory Affairs (GRL)

Job Description

Job Title: Director, Global Regulatory Affairs (GRL)

Job Requisition ID: 2046

Posting Start Date: 8/18/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

**Job Summary**

The Global Regulatory Lead (GRL) is responsible for leading and developing global regulatory strategy for assigned development projects. The GRL represents Daiichi Sankyo's regulatory group in internal and external development project meetings, provides guidance to peers and cross-functional team members regarding strategic regulatory issues, and develops overall regulatory strategy with input from respective regional strategists for global Health Authority interactions. The GRL is responsible for representing Global Regulatory Affairs on the Global Project Team (GPT), as well as in early- and late-stage governance meetings. The GRL interfaces with clinical and non-clinical groups, Regulatory CM&C, Biostatistics, Companion Diagnostics, Precision Medicine, and other appropriate functions within the company.

**Job Description**

**Responsibilities**

- Manages, directs, and drives the strategy for all regulatory activities associated with the registration and support of new and approved drug products.
- Responsible for ensuring aligned global regulatory strategy is endorsed by the Global Project Team and governance bodies.
- Serves as a leader of the Global Regulatory Team (GRT) and is responsible for strategic integration of regional strategies, including an understanding of CMC, supply chain and commercialization aspects to support Health Authority requirements. This includes review of key regulatory documents, e.g., protocols, briefing books, and health authority submission documents.
- Serves as the primary point of contact with Alliance Partners Joint-regulatory teams and Joint-GPT.
- Keeps current with latest Health Authority guidelines and provides regulatory advice to members within Regulatory, and other departments within the Company.
- Communicates with outside consultants (i.e. CROs, external partners) as needed.

**Qualifications**

**Education Qualifications** (from an accredited college or university)

- Bachelor's Degree preferably in a scientific discipline required
- Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD) preferred

**Experience Qualifications:**

- Broad and deep scientific and regulatory expertise in early- and late-stage development across modalities and therapeutic areas with focus on oncology
- Drug Discovery and Development knowledge across the R&D continuum
- 7 or more years of relevant pharmaceutical experience including 5 years of experience in a Strategy role within Regulatory Affairs
- Hands on NDA/BLA submission experience in a major geographical region, including the US
- Demonstrated experience in global Health Authority negotiations
- Manages complexity of regulatory strategy across regions and has the knowledge to provide regulatory guidance based on understanding of global regulations
- Communicates and collaborates effectively and deals well with ambiguity
- Working knowledge of CMC and Companion Diagnostics

**Travel Requirements**

Ability to travel up to 20% of the time.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

**Salary Range:**

USD$193,040.00 - USD$289,560.00

[Download Our Benefits Summary PDF](<https://dmscdn.successfactors.com/886bee122c7aa5b9923a39bc71a2674d43c27f80448c122562765b1812b407af/static_content/1659df144cbb4da8ae09/2026_BenefitsHighlightsForPublicPosting.pdf>)

Professionals

Associate Director, Regulatory Affairs Advertising and Promotion

Job Description

Job Title: Associate Director, Regulatory Affairs Advertising and Promotion

Job Requisition ID: 1826

Posting Start Date: 7/16/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

**Job Summary**

The Associate Director, Regulatory Affairs Advertising and Promotion (RAAP) provides strategic and tactical regulatory support for U.S. promotional and selected non-promotional communications across assigned products, disease-state initiatives, and related external-facing materials within the Daiichi Sankyo portfolio.

Reporting to the Head of RAAP, this role serves as a primary Regulatory reviewer and subject matter expert for assigned scope and helps ensure materials are developed, reviewed, and approved in accordance with FDA regulations, guidance, approved labeling, internal standards, and relevant regulatory precedent prior to dissemination.

The Associate Director provides practical, risk-based regulatory guidance to cross-functional stakeholders and supports compliant, business-aligned promotional execution. This role is responsible for independent day-to-day review of assigned materials, participation in cross-functional review forums, and contribution to review practices that improve consistency, efficiency, and transparency across the RAAP function.

The Associate Director applies established regulatory standards and precedent within assigned scope and escalates novel, high-risk, or precedent-setting matters to the Head of RAAP, as appropriate.

**Job Description**

**Responsibilities**

Promotional Review, Regulatory Intelligence, and Regulatory Assessment

- Provide regulatory review, guidance, risk assessment, and mitigation recommendations for branded and unbranded promotional materials to ensure compliance with FDA advertising and promotion requirements, approved labeling, internal policies, and company standards.
- Review a broad range of HCP- and patient-facing promotional materials and assess them for consistency with prescribing information, fair balance, risk communication, evidentiary support, and relevant FDA/OPDP expectations.
- Apply current laws, regulations, guidances, enforcement trends, and regulatory precedent to assigned reviews and recommend practical, compliant solutions that support business objectives.
- Maintain current knowledge of evolving advertising and promotion requirements and communicate relevant regulatory developments and implications to stakeholders and colleagues.

Strategic Regulatory Guidance and Cross-Functional Leadership

- Participate in concept-stage discussions and formal promotional review meetings to provide proactive, solution-oriented, and risk-based regulatory guidance during material development.
- Serve as the RAAP reviewer for assigned products and communications within PMRT and other cross-functional review forums.
- Partner with Medical, Legal, Compliance, Commercial, Clinical, Labeling, Public Affairs, Corporate Communications, Market Access, including alliance partners to support aligned, efficient, and compliant review of promotional materials.
- Build effective working relationships with stakeholders and escalate significant regulatory issues, interpretive questions, or unresolved cross-functional disagreements to RAAP leadership, as appropriate.

Governance, Policy Interpretation, and Health Authority Support

- Serve as a RAAP reviewer in promotional review committees and as a functional representative on the Labeling Working Team for assigned products and materials, as appropriate.
- Guide and support required promotional submissions, including Form FDA 2253, Subpart E/H, advisory comment submissions, and other regulatory filing activities.
- Support ad/promo interactions with OPDP and other regulatory authorities in partnership with RAAP leadership.
- Apply current FDA regulations, guidances, enforcement trends, compliance letters, and relevant regulatory precedent to assigned reviews, and escalate ambiguous, novel, or high-risk interpretive issues as appropriate.

Functional Support, Process Improvement, and Capability Building

- Support implementation and reinforcement of consistent RAAP review practices, workflows, decision principles, and review expectations across assigned products and materials.
- Assist in development, maintenance, and application of internal procedures, standards, guidance documents, and review tools related to promotional review.
- Support continuous improvement efforts that enhance review quality, consistency, transparency, and efficiency across the RAAP function.
- Provide training and knowledge-sharing for internal stakeholders on advertising and promotion requirements, enforcement trends, and company expectations.

**Qualifications**

**Education Qualifications**

- Bachelor's Degree Scientific, healthcare, or related discipline required
- PharmD, PhD, MS, MPH, or JD preferred

**Experience Qualifications**

- 7+ years relevant pharmaceutical or biotechnology industry experience in Regulatory Affairs, including direct support of U.S. advertising and promotion review preferred
- 4+ years U.S. regulatory affairs advertising and promotion review experience in oncology with product launch experience required

**Travel Requirements**

In-house office position that may require occasional travel.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

**Salary Range:**

USD$166,720.00 - USD$250,080.00

[Download Our Benefits Summary PDF](<https://dmscdn.successfactors.com/886bee122c7aa5b9923a39bc71a2674d43c27f80448c122562765b1812b407af/static_content/1659df144cbb4da8ae09/2026_BenefitsHighlightsForPublicPosting.pdf>)

Professionals

Director, Regulatory Affairs, Companion Diagnostics

Job Description

Job Title: Director, Regulatory Affairs, Companion Diagnostics

Job Requisition ID: 2194

Posting Start Date: 9/14/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

**Job Summary**

Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical products. Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.

**Job Description**

**Responsibilities**

CDx development: Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before and after CDx testing

- At the time of implementation of a CDx study/IVDR performance evaluation study & integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)
- Serve as the Point of Contact (PoC) for gathering country/region specific CDx RA requirements from local RA team members (e.g. from Japan, China, Australia, Canada, Korea etc.)
- For recruitment in EU: It is critical that this person has, and continues to develop regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR requirements to enable and support timely registration of both therapeutic and diagnostic products in the EU as well as UK and Switzerland.

CDx RA Strategy: Represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (e.g., Diagnostic Development Teams) and to external diagnostic business partners specifically:

- Use of CTA/CDx within clinical trials
- Device protocols and SAPs
- Device non-significant/significant risk determinations (both submission to CDRH in a Q-sub process and in a streamlined fashion within protocol submission to CDER via the INDs), IDEs
- Biomarker strategies towards patient selection, patient stratification, bridging between CTA/CDx assays, prospective vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures.
- Clinical trial protocol development and reviews (clinical trial protocols and medical device protocols)
- ICF reviews to ensure adequate disclosure for collection, retention, testing and retesting of samples

Project Team Participation: Provide device-specific regulatory insight/guidance during CDx Indication Team & Working Group (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to communicate key RA updates from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with the creation of contingency/backup plans for CDx submission. Health Authority Submission Preparation: Assist with preparation of pre-submission documents and CDx related portions of therapeutic marketing applications and respond to regulatory queries/feedback from HAs. Contribute to providing timely feedback for Dx Partners to address regulatory questions from Global Health Authorizes (HAs) during review of device submissions

- In collaboration with CDx lead work with Dx partners to ensure robust development of assay, participate in HA interaction for drug-related CDx topics/questions, and attend device company HA meetings as appropriate
- In collaboration with therapeutic Regulatory leads and CDx lead develop key questions and company positions related to CDx for Health Authority interactions (for both sponsor and partner side)

CDx RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these changes

- Assessing the impacts of relevant drug and diagnostic regulations on the development and registration activities for the respective medical products
- Contribute to shared learning forums, workshops and training on new guidances, regulations to enterprise
- Sharing case studies with enterprise

**Qualifications**

**Education Qualifications**

- Bachelor's Degree preferably in a scientific discipline required
- Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD preferred

**Experience Qualifications**

- 7+ years relevant pharmaceutical experience including experience within Regulatory Affairs required
- Understanding of scientific content and complexities and good knowledge of diagnostic development, including extensive experience of IDE submissions and approvals required
- Extensive experience developing companion diagnostics and devices required
- Experience of drug development and drug regulatory procedures.
- Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process required

**Travel Requirements**

Ability to travel up to 10% of the time. Occasional travel to Health Authority meetings in US and Europe, potentially Japan.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

**Salary Range:**

USD$184,240.00 - USD$276,360.00

[Download Our Benefits Summary PDF](<https://dmscdn.successfactors.com/886bee122c7aa5b9923a39bc71a2674d43c27f80448c122562765b1812b407af/static_content/1659df144cbb4da8ae09/2026_BenefitsHighlightsForPublicPosting.pdf>)

Professionals

Protara Therapeutics

Paralegal

**Company Overview:**

Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes.

Protara was named one of the **Best Places to Work** by BioSpace, a leading industry news and job source. This honor demonstrates the company’s desirability in the recruitment marketplace, looking at various merits with an emphasis on culture, career growth and development opportunities, leadership and innovation. Attracting and retaining top talent is integral to building a successful company in biotech, and we are committed to ensuring Protara provides our employees with an exceptional experience throughout their careers, even as we continue to grow.

**Job Overview:**

Protara is seeking a highly organized and detail-oriented Paralegal to support the Legal & Compliance function focused on developing innovative therapies for patients with NMIBC (non-muscle invasive bladder cancer) and rare diseases. This role will provide broad legal and administrative support across contracting, commercial, clinical, regulatory, intellectual property, corporate governance, and compliance activities. The ideal candidate will thrive in a fast-paced, highly regulated environment and have experience supporting legal operations within the life sciences, pharmaceutical, or biotechnology industries.

**\*This person must be able to come into the NYC office twice a week.**

\***Essential Duties and Responsibilities** include the following. Other duties may be assigned.

- Assist with the preparation, review, tracking, and administration of a wide variety of agreements, including:
  - Confidentiality and non-disclosure agreements (NDAs)
  - Clinical trial agreements
  - Vendor and consulting agreements
  - Master service agreements (MSAs)
  - Research collaboration agreements
  - Licensing and manufacturing agreements
  - Sponsorship and grant agreements
- Manage contract lifecycle processes, including intake, execution, filing, renewals, and reporting
- Maintain contract management systems and legal databases to ensure accurate records and accessibility
- Coordinate contract signatures through Docusign

**Corporate Governance**

- Assist with corporate entity management, including maintaining corporate records, minute books, resolutions, and governance documentation
- Prepare materials for board meetings and committee meetings as requested
- Support annual filings and corporate compliance requirements

**Cross-Functional Collaboration**

- Partner closely with Finance, Research & Development, Commercial and Human Resources teams
- Serve as a trusted resource for business stakeholders seeking guidance on legal processes and documentation

**Education**

- A bachelor’s degree is required
- Paralegal certificate from an ABA-approved program preferred

**Experience**

- 3–7 years of paralegal experience, preferably within biotechnology, pharmaceuticals, healthcare, medical devices, or a highly regulated industry
- Experience supporting in-house legal departments strongly preferred
- Experience with contract management systems and legal operations tools

**Knowledge, Skills & Abilities**

- Understanding legal and regulatory frameworks applicable to biotechnology, pharmaceutical, or life sciences companies
- Knowledge of clinical research, drug development, and healthcare compliance concepts preferred
- Strong contract administration and document management skills
- Exceptional organizational skills and attention to detail
- Ability to manage multiple priorities and meet deadlines in a dynamic environment
- Excellent written and verbal communication skills
- Proficiency with Microsoft Office Suite and legal technology platforms

**Preferred Qualifications**

- Experience supporting companies focused on oncology, rare diseases, biologics, or specialty therapeutics
- Familiarity with FDA regulations, GxP environments, Sunshine Act reporting, and international compliance requirements
- Experience working with intellectual property portfolios and external patent counsel
- Experience supporting publicly traded biotechnology companies is a plus

**Core Competencies**

- Integrity and professionalism
- Sound judgment and discretion
- Collaboration and relationship building
- Problem solving and critical thinking
- Adaptability and continuous improvement
- Customer service mindset
- Commitment to improving outcomes for patients with serious and rare diseases

**Supervisory Responsibilities:** None

**Computer Skills:**

- Must be proficient in the MS Office Suite.

**Certificates, Licenses, Registrations:** none required

**Other Skills and Abilities:**

- Strong interpersonal skills, including ability to communicate effectively with diverse audiences and build strong relationships
- Excellent written and oral communication and presentation skills
- Ability to prioritize and multi-task successfully in a fast-paced environment
- Excellent organizational skills and attention to detail are essential
- It is essential that this individual demonstrates the ability to work with highly confidential information
- Ability to manage both day-to-day operations as well as project work in a fast-paced environment
- Strong analytical and problem-solving skills
- Ability to work both independently and in a collaborative team setting
- Proficiency in data mining/data extraction
- Demonstrated experience working with and presenting to senior level management
- Ability to work through uncertainty

\*Salary Requirements are between $115,000 - $120,000 based on job-related knowledge, experience, education, and skills demonstrated. We offer a competitive Compensation & Benefits package including incentive bonus, equity compensation, matching 401(k), medical, dental, vision, commuter, and fertility benefits.

**Why You’ll Love Working at Protara**

- **Friendly, open, and fun team-oriented culture that values unique & diverse perspectives.**
- **Company-wide dedication to profoundly impacting patients’ lives.**
- **Amazing culture whereby our core values and behaviors are shared cross-functionally.**
- **Flexible working hours/schedules.**
- **Generous Paid Holidays and Unlimited PTO.**

*Protara is committed to being a diverse and inclusive workplace. Protara is an Equal Opportunity Employer and is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, creed, religion, national or ethnic origin, citizenship status, age, sex or gender, gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information or any other characteristic protected by applicable federal, state or local laws*.

New York

Senior Director, Assistant General Counsel

**Company Overview:**

Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes.

Protara was named one of the **Best Places to Work** by BioSpace, a leading industry news and job source. This honor demonstrates the company’s desirability in the recruitment marketplace, looking at various merits with an emphasis on culture, career growth and development opportunities, leadership and innovation. Attracting and retaining top talent is integral to building a successful company in biotech, and we are committed to ensuring Protara provides our employees with an exceptional experience throughout their careers, even as we continue to grow.

**Job Overview:**

The Senior Director, Assistant General Counsel, serves as a legal leader and strategic business partner supporting Protara’s mission to develop and commercialize TARA 002 and IV Choline Chloride for patients with non-muscle invasive bladder cancer, (NMIBC) and rare diseases.

Reporting to the Chief Legal and Compliance Officer, the incumbent will advise SEC, R&D, Clinical Development and corporate functions to enable business objectives while managing legal and compliance risks in a highly regulated biotechnology environment.

This is a critical leadership role requiring deep experience in the biopharmaceutical industry, including expertise in FDA-regulated activities, clinical development, strategic transactions, product commercialization, and healthcare compliance.

**\*This person must be able to come into the NYC office once a week.**

**Essential Duties and Responsibilities** include the following. Other duties may be assigned.

**Strategic Legal Counsel**

- Serve as a trusted advisor to senior leadership on legal, regulatory, and business matters impacting the company's oncology and rare disease portfolio
- Provide practical, risk-balanced legal guidance aligned with corporate objectives and patient-focused values
- Advise on emerging legal, regulatory, healthcare, and industry developments affecting the biotechnology sector
- Support Board and executive management initiatives as needed

**Commercial & Medical Affairs Support**

- Review and advise on promotional materials, disease-awareness campaigns, digital initiatives, and medical communications
- Partner with Medical Affairs on scientific exchange, publication strategies, advisory boards, investigator engagements, and medical education programs
- Advise Commercial and Market Access teams on contracting, pricing, reimbursement, patient support programs, and interactions with healthcare professionals and institutions

**Healthcare Compliance & Ethics**

- Collaborate with Compliance leadership to ensure adherence to:
  - Anti-Kickback Statute
  - False Claims Act
  - FDA promotional regulations
  - Sunshine Act/Open Payments requirements
  - HIPAA and privacy laws
  - Industry codes, including PhRMA and AdvaMed
- Conduct legal risk assessments and support investigations, audits, and corrective action initiatives
- Deliver training and guidance to business stakeholders on legal and compliance obligations

**Business Development & Corporate Transactions**

- Support licensing, collaboration, co-development, co-promotion, supply, manufacturing, and commercial partnership transactions
- Lead negotiation and draft complex strategic agreements
- Provide legal support for mergers, acquisitions, divestitures, joint ventures, and other strategic initiatives
- Conduct due diligence and advice on transaction-related risks and mitigation strategies.

**Contracting & Legal Operations**

- Draft, review, and negotiate a broad range of commercial and operational agreements.
- Manage outside counsel and legal spend effectively
- Develop and improve contracting processes, templates, and legal operations efficiencies
- Support enterprise risk management initiatives

**Privacy & Data Governance**

- Advise on data privacy and cybersecurity matters affecting clinical, commercial, and corporate operations
- Counsel stakeholders on patient data, clinical trial data, secondary use of data, artificial intelligence initiatives, and cross-border data transfer issues and GDPR
- Support implementation of privacy programs and governance frameworks

**Leadership & Cross-Functional Collaboration**

- Build strong partnerships across business functions to foster a culture of compliance, accountability, and innovation
- Contribute to strategic planning and legal department initiatives

**Supervisory Responsibilities:** None currently, subject to change.

**Education/ Qualifications:**

- Juris Doctor (J.D.) degree from an accredited law school
- Active membership in good standing with at least one U.S. state bar
- 12+ years of legal experience, including significant in-house experience within biotechnology, pharmaceutical, life sciences, or healthcare organizations
- Demonstrated experience supporting oncology, rare disease, specialty pharmaceutical, or advanced therapy programs preferred
- Strong knowledge of FDA regulatory frameworks and pharmaceutical commercialization
- Experience supporting clinical development and Medical Affairs organizations
- Significant contracts and transaction experience, including strategic collaborations and licensing arrangements
- Prior law firm experience preferred
- Deep understanding of the biotechnology and pharmaceutical legal landscape
- Strong knowledge of:
  - FDA regulations
  - Healthcare fraud and abuse laws
  - Clinical trial regulations
  - Data privacy and data governance requirements
  - Commercialization and market access issues
  - Exceptional drafting, negotiation, and communication skills
  - Ability to balance legal risk with business objectives in a fast-paced environment
  - Sound judgment and strong executive presence
  - Excellent relationship-building and influencing skills across all organizational levels
  - Demonstrated ability to manage complex, high impact matters independently
  - Strategic thinker with strong analytical and problem-solving capabilities
  - High integrity and commitment to ethical leadership

**Preferred Qualifications**

- Experience supporting global biotechnology organizations.
- Expertise in oncology, hematology, cell and gene therapy, rare disease, or orphan drug programs
- Experience with launch and commercialization of specialty therapeutics
- Familiarity with international regulatory and compliance frameworks
- Experience supporting publicly traded biotechnology companies.

- The ideal candidate is a pragmatic, business-oriented attorney who thrives in a dynamic biotechnology environment and is passionate about advancing therapies for patients with serious and life-threatening diseases. This individual combines strong legal expertise with strategic thinking, collaboration, and leadership to help the company achieve its scientific, clinical, and commercial objectives while maintaining the highest standards of integrity and compliance.

**Computer Skills:**

- Must be proficient in Microsoft Office Suite.

**Certificates, Licenses, Registrations:** must be a member of NY or another state Bar.

**Other Skills and Abilities:**

- Strong interpersonal skills, including ability to communicate effectively with diverse audiences and build strong relationships
- Excellent written and oral communication and presentation skills.
- Ability to prioritize and multi-task successfully in a fast-paced environment.
- Excellent organizational skills and attention to detail are essential
- It is essential that this individual demonstrates the ability to work with highly confidential information.
- Ability to manage both day-to-day operations as well as project work in a fast-paced environment.
- Strong analytical and problem-solving skills.
- Ability to work both independently and in a collaborative team setting.
- Proficiency in data mining/data extraction.
- Demonstrated experience working with and presenting to senior level management.
- Ability to work through uncertainty.

**Physical Demands:**

*The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.*

- This position requires minimal travel; average travel for this position is 5% with some variation based upon the demands of the business imperatives.

**Work Environment:**

*The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.*

No specific work demands.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.*

\*Salary Requirements are between $300,000 - $305,000 based on job-related knowledge, experience, education, and skills demonstrated. We offer a competitive Compensation & Benefits package including incentive bonus, equity compensation, matching 401(k), medical, dental, vision, commuter, and fertility benefits.

**Why You’ll Love Working at Protara**

- **Friendly, open, and fun team-oriented culture that values unique & diverse perspectives.**
- **Company-wide dedication to profoundly impacting patients’ lives.**
- **Amazing culture whereby our core values and behaviors are shared cross-functionally.**
- **Flexible working hours/schedules.**
- **Generous Paid Holidays and Unlimited PTO.**

*Protara is committed to being a diverse and inclusive workplace. Protara is an Equal Opportunity Employer and is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, creed, religion, national or ethnic origin, citizenship status, age, sex or gender, gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information or any other characteristic protected by applicable federal, state or local laws*.

Dyne Therapeutics

Executive Director, Regulatory Affairs

**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 Executive Director, Regulatory Affairs serves as a visionary leader who shapes long-term program regulatory strategy, collaborates on regulatory functional strategy, and drives organizational impact across Dyne's regulatory operations. The Executive Director provides strategic program direction for regulatory affairs, ensuring compliance with applicable regulations and maintaining strong relationships with regulatory bodies. This position requires a leader who contributes to department-wide strategy, develops corporate policies and processes that influence the organization's direction, and ensures alignment with the mission of delivering meaningful outcomes for patients. The role demands strategic program regulatory oversight and execution of regulatory strategies that align with business objectives and support the achievement of timely regulatory interactions and filings. This role requires a leader with emotionally intelligent leadership, embedding Dyne's values into long-term people strategies while ensuring accountability, talent development, and organization-wide alignment.

This role is based in Waltham, MA.

**Primary Responsibilities Include:**

- Shape and lead comprehensive global regulatory strategy for a Dyne program, driving long-term vision that aligns with corporate, functional, and program objectives and advances patient-focused mission
- Contribute to functional strategy by collaborating to establish mid-term goals, setting strategic priorities, and ensuring execution aligns with financial performance targets and organizational objectives
- Provide strategic oversight of regulatory function for a program through functional managers and leaders, setting the tone for emotionally intelligent, feedback-driven leadership across the organization
- Partner with executive stakeholders to negotiate and influence critical regulatory matters affecting the entire organization, building trust through transparent communication and inclusion
- Develop and execute corporate regulatory policies that influence organizational direction, ensuring alignment with delivering meaningful outcomes for patients
- Lead interactions with global health authorities including FDA, EMA, and other regulatory agencies, representing the company at critical strategic meetings and shaping regulatory pathway decisions
- Ensure compliance with regulatory requirements throughout the product lifecycle
- Oversee preparation and submission of major regulatory filings including INDs, CTAs, NDAs, BLAs, and MAAs, maintaining compliance with all regulatory requirements
- Direct regulatory program strategy for expedited programs and designations for rare muscle diseases, including Fast Track, Orphan Drug Designation, Breakthrough Therapy, and Regenerative Medicine Advanced Therapy designations
- Foster innovation and bold thinking across the regulatory team by leveraging deep company knowledge, guiding functional leaders in embedding purpose, accountability, and emotional intelligence into operations
- Lead talent development initiatives, mentoring senior regulatory professionals and building organizational capability to support long-term growth and sustained high performance
- Exercise judgment in contributing to corporate strategy, addressing complex and intangible organizational challenges related to regulatory science and policy
- Interact internally and externally with executive stakeholders across the organization, negotiating and influencing critical matters that affect the entire enterprise
- Contribute to strategic direction for the regulatory function and influences enterprise-wide initiatives, building trust through transparent communication, empowerment, and inclusion while modeling high standards of leadership across the company
- Leverage deep company knowledge to foster innovation, guide functional managers and leaders in embedding purpose, accountability, and emotional intelligence into operations, and model Dyne's values through leading with commitment and resolve
- Exercise judgment in setting and contributing to program and functional strategy, establishes mid-term goals, sets priorities, and ensures execution aligns with corporate objectives and financial performance targets
- Monitor global regulatory trends and provide strategic guidance to senior leadership
- Embed Dyne's values into long-term people strategies, and ensure accountability, talent development, and organization-wide alignment
- Encompass broad decision-making latitude in addressing complex organizational challenges, anticipating regulatory risks and opportunities, and making decisions that influence department-wide direction and enterprise strategy
- Lead regulatory inspections and audits and ensure corrective actions are implemented promptly
- Develop and mentor the regulatory affairs team on best practices and regulatory changes
- Collaborate cross-functionally for successful product development and launch

**Education and Skills Requirements:**

- A Bachelor's degree in life sciences or related discipline is required, with a Master's degree preferred
- 18+ years of progressive experience in regulatory affairs with a minimum of 10 years in management or leadership roles
- Deep expertise in regulatory strategy for clinical-stage biotechnology companies is essential, with strong experience in CTD format and content for regulatory filings
- Demonstrated knowledge of FDA, EMA, and international regulations related to clinical, nonclinical, and CMC development is critical
- Deep industry knowledge
- Ability to apply strategic thinking to foster innovation
- Models Dyne's values of purpose, commitment, vision, and resolve
- Experience leading health authority meetings, negotiating with regulatory agencies, and influencing enterprise-wide regulatory decisions
- Outstanding communication skills including regulatory writing, cross-functional collaboration, and the ability to effectively communicate regulatory strategy, risks, and mitigation plans to executive leadership are essential

\#LI-Onsite

MA Pay Range

$294,000 - $318,000 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.*

BioMarin Pharmaceutical Inc.

Senior Director, Health Economics & Outcomes Research (HEOR)

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Commercial

Be part of the worldwide infrastructure that gets our drugs to underserved patients around the world. Our global sales force solidifies BioMarin’s commercial presence in the United States and Europe and is rapidly growing in other regions, such as South America, EuMEA, and Asia-Pacific.

Summary

The Health Economics & Outcomes Research (HEOR) Senior Director leads asset-specific payer evidence strategies, including patient-relevant outcomes strategy, to generate differentiated evidence, strengthen the payer value proposition, and optimize access for BioMarin assets across all therapeutic areas of interest. s. The role is responsible for shaping patient-relevant outcomes requirements within the clinical programs, ensuring alignment with Regulatory, HTA and access needs. In partnership with internal cross-functional and external stakeholders, the Senior Director leads the design and execution of patient-relevant outcomes research initiatives.

The Sr. Director cultivates strong partnerships with cross-functional partners across Value & Access, Commercial, Medical Affairs, Clinical Development, Regulatory Affairs and Patient Advocacy, while engaging with external stakeholders including HTA agencies, payers and patient organizations. This role requires deep expertise in patient-relevant outcomes research and a strong understanding of market access, value and HTA frameworks.

The position reports to the ED, Head of the Global HEOR team, which sits within the Pricing Access Value & Evidence (PAVE) organization and has a direct report.

Description

• Lead the development, execution and communication of payer evidence strategies aligned with brand and Value & Access priorities for early-stage pipeline assets

• Collaborate closely with Value & Access, Commercial, Medical Affairs, Clinical Development & Regulatory Affairs & Patient Advocacy organizations

• Drive organizational understanding of payer and HTA requirements related to patient-relevant outcomes and health utility measurement

• Drive the strategic assessment for patient-relevant outcomes requirements for HTA and access to support differentiation and value demonstration

• Ensure payer evidence requirements are incorporated into clinical development plans to enable optimal patient access

• Lead the development of cross-functionally aligned, asset-specific patient-relevant outcomes strategies informed by disease conceptual models

• Lead patient-relevant endpoint planning and provide oversight of implementation within clinical trials

• Lead early Joint Clinical Assessment (JCA) strategy development, including assessment of access implications and trade-offs across markets

• Assess payer evidence gaps and inform future integrated evidence planning for early-stage pipeline assets

• Manage and partner with external partners in the execution of asset-level patient-relevant outcomes strategies, including PRO development and validation, health state valuation studies (time trade-off or standard gamble), and patient preference research, as appropriate

• Lead scientific interactions with HTA agencies, particularly scientific advice (e.g., EU HTA JSC, NICE, CADTH), including preparation of briefing materials and evidence packages related to PRO endpoints, MCIDs, etc

• Support scientific interactions with regulatory agencies and patient advocacy organizations

• In partnership with the Integrated Evidence Teams (IET), lead the exploration, analysis and interpretation of patient-relevant outcomes data from clinical trials to generate insights, and strengthen value propositions for HTA, payer and other stakeholders

• Shape strategic scientific communication plans, and lead presentation and publication of research in peer-reviewed journals

• Assess business development opportunities against payer and HTA requirements to identify risks, evidence gaps, and access considerations

Education & Experience

• 12+ years of Pharma Industry experience with 7+ years of experience in HEOR roles in pharmaceutical companies or consulting, and at least 5 years of direct experience with patient-relevant outcomes research

• Advanced degree in health economics, outcomes research, epidemiology, public health, health services research, pharmacy, or a related scientific discipline

• Deep understanding of market access, value and global HTA frameworks

• Demonstrated experience developing and executing patient-relevant outcomes strategies to meet payer and HTA requirements

• Prior experience in the evaluation, development, and validation of PRO measures to support regulatory, payer, and HTA decision making

• Experience supporting HTA submissions, value dossiers, and patient-relevant briefing books

• Proven ability to influence and drive alignment across senior cross-functional stakeholders, including Value & Access, Commercial, Medical Affairs, Clinical Development & Regulatory Affairs

• Ability to lead multiple complex initiatives and effectively prioritize in a dynamic, fast-paced environment

• Recognized leader within the patient-reported outcomes field, with a strong professional network and external visibility

• Experience engaging with external stakeholders, including HTA agencies, payers, health economists, clinical experts, and patient advocacy organizations

• Rare disease experience preferred

• Prior people leadership experience, including talent development preferred

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

California

Associate Director, Legal, Corporate Counsel, Product and Commercial

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Corporate Groups

It takes a village, and at BioMarin, our general and admin teams are the village behind our success. From the IT experts who manage our technology to the human resources professionals who hire the people who make it all possible, these teams support our organization and span all areas of operations.

**Associate Director, Corporate Counsel, Product and Commercial**

**Role and Responsibilities**

- Counsel internal stakeholders regarding advertising and promotion, external communications, sales and marketing initiatives, FDA and OIG guidance, and industry codes (e.g. PhRMA) as they relate to business activities and communications with healthcare professionals, payors, patients, and/or patient advocacy organizations.
- Serve as Legal reviewer across MLR committees for assigned products and disease states
- Independently draft, review, and negotiate commercial contracts to support BioMarin’s Commercial organization.
- Provide analysis, guidance, training, and support to functions such as Marketing, Sales, Market Access, Patient Advocacy, Medical Affairs, and Corporate Communications engaged in external communications and outreach related to pipeline and/or approved products and related conditions.
- Advise internal stakeholders on potential legal issues and appropriate risk mitigation strategies regarding advertising, promotion, product liability, anti-trust, and relevant healthcare rules and regulations (e.g., fraud and abuse, anti-kickback, and false claims act statutes).
- Work closely with Global Compliance & Ethics Program including counseling and training on compliance policies and healthcare compliance regulations.
- Assist with periodic compliance risk assessments and investigations of alleged violations of corporate policies and procedures, laws, or regulations, and advise on development and implementation of corrective action plans where compliance violations have been established.
- Prepare regular briefing documents to keep Executive Management up to date on latest industry events and trends related to key risk areas including OIG and FDA enforcement, CIA trends, and analysis of OPDP warning and untitled letters.
- Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology companies, along with recent industry trends and changes.

**Education**

A JD degree and active bar license

**Experience**

- 3 - 7 years of experience working in a law firm or the pharmaceutical/healthcare legal/compliance field. Experience in-house, at a regulatory agency, or at a major law firm also welcome.
- Experience with pipeline and marketed brand support and associated statutes, regulations, guidance documents, enforcement trends, and best practices related to the pharmaceutical, biotechnology, and/or healthcare industry generally.
- Experience with AdPromo framework and as reviewer on MLR
- Experience in drafting, reviewing, and negotiating commercial agreements.
- Experience with the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines.
- Experience with the legal/compliance framework affecting the pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and abuse issues, OIG and other industry guidance documents, clinical trial regulations, and issues arising under the Anti-Kickback Statute and the False Claims Act.
- Demonstrated effectiveness operating in complex organizational and regulatory environments.
- Excellent written, oral, and presentation skills.
- Proven ability to work with all levels of management and the general workforce, a strong sense of professionalism, and the drive to provide superb and timely support to internal clients.
- Strong problem solving, risk analysis, and project management skills.
- Demonstrated ability to partner effectively with others in addressing complex issues.
- Strong persuasive skills and sound business judgment.
- Motivated, self-starter with ability to appropriately prioritize issues, drive projects, and allocate resources.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Director, Corporate Counsel, Early Research & Development

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Corporate Groups

It takes a village, and at BioMarin, our general and admin teams are the village behind our success. From the IT experts who manage our technology to the human resources professionals who hire the people who make it all possible, these teams support our organization and span all areas of operations.

**Position Summary**

BioMarin is seeking an experienced and business-oriented attorney to serve as the lead legal support and strategic advisor for its Early Research & Development (RED) organization. This role will partner closely with scientific, business, and functional leaders to enable innovative research collaborations, advance BioMarin's pipeline, and support the company's long-term strategic objectives.

The Director, Corporate Counsel, Early Research & Development will provide proactive legal counsel on a broad range of research, innovation, intellectual property, and transactional matters. The successful candidate will possess deep experience negotiating and drafting complex research and collaboration agreements including licenses, strong intellectual property acumen, and a demonstrated ability to effectively partner with scientists and senior business leaders in a fast-paced life sciences environment.

**Key Responsibilities**

**Strategic Legal Partnership**

- Serve as the primary legal advisor to BioMarin's Early Research & Development organization.
- Provide practical, risk-based legal counsel to scientific and business stakeholders to support research initiatives, external innovation activities, and strategic collaborations.
- Partner closely with senior leaders across Worldwide Research & Development (WWRD), Business Development, Intellectual Property, Alliance Management, Procurement, and other functions.
- Develop trusted relationships with executive and senior leadership and contribute to strategic decision-making.

**Transactional Support**

- Lead the drafting, review, negotiation, and execution of a wide variety of agreements supporting research and development activities, including:
- Confidential Disclosure/Non-Disclosure Agreements (CDAs/NDAs)
- Master Services Agreements (MSAs)
- Material Transfer Agreements (MTAs)
- Sponsored Research Agreements (SRAs)
- Research Collaboration Agreements
- Option, License, and Technology Evaluation Agreements
- Academic and Institutional Collaborations
- Consulting and Scientific Advisory Agreements
- Other strategic research and development transactions
- Structure and negotiate complex licensing, research, and collaboration arrangements involving proprietary technologies, intellectual property rights, and scientific data.
- Advise stakeholders on contractual risk allocation, governance structures, publication rights, ownership of intellectual property, data rights, and commercialization considerations.

**Intellectual Property and Innovation Support**

- Partner with BioMarin's Intellectual Property team to support patent strategy and technology transactions.
- Provide strategic legal guidance to business stakeholders regarding intellectual property protection, ownership, licensing, and commercialization.
- Advise on intellectual property aspects of collaborations with academic institutions, biotechnology companies, vendors, and other external partners.

**Cross-Functional Leadership**

- Collaborate effectively with Legal, Intellectual Property, Compliance, Business Development, Procurement, and Research leadership teams.
- Support due diligence activities and strategic partnering opportunities involving early-stage science and technology.
- Develop and improve contracting processes, templates, policies, and training materials to support research and development operations.
- Monitor legal and regulatory developments affecting research collaborations, innovation partnerships, and intellectual property rights.

**Qualifications**

**Required**

- J.D. degree from an accredited law school and active membership in at least one U.S. state bar.
- 7+ years of relevant legal experience, including substantial experience in the biotechnology, pharmaceutical, life sciences, or related industry.
- Significant experience negotiating and drafting research, collaboration, licensing, and technology-related agreements.
- Deep understanding of intellectual property principles, including patent, licensing, ownership, and commercialization issues.
- Demonstrated ability to provide strategic legal counsel in a complex and highly collaborative environment.
- Experience partnering directly with scientific teams and translating complex scientific concepts into practical legal advice.
- Excellent negotiation, communication, and stakeholder management skills.
- Ability to independently manage a diverse portfolio of sophisticated legal matters.

**Preferred**

- In-house legal experience within a biotechnology or pharmaceutical company.
- Experience supporting early-stage research, discovery, translational science, or external innovation organizations.
- Familiarity with academic collaborations, sponsored research arrangements, and technology transfer practices.
- Experience supporting business development transactions, licensing activities, and strategic partnerships.
- Advanced scientific training or demonstrated aptitude for understanding complex scientific and technical concepts.

**Leadership Competencies**

- Strategic thinker with strong business judgment.
- Collaborative and solutions-oriented approach.
- Ability to influence and build credibility with senior leaders and cross-functional stakeholders.
- Skilled at balancing innovation enablement with appropriate risk management.
- Strong organizational skills and ability to manage competing priorities in a dynamic environment.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.