SERM Senior Scientific Director, Oncology

As a senior leader within Global Safety, the Senior Scientific Director, Clinical Safety (Oncology) provides strategic scientific leadership and oversight of clinical safety and pharmacovigilance activities across assigned oncology assets. This role is accountable for driving safety strategy, enabling robust benefit-risk assessment, and ensuring the proactive identification, evaluation, and management of safety risks across both clinical development and post-marketing settings.

This position plays a critical role in protecting patient safety globally while influencing enterprise safety strategy and decision-making.

- Define and drive the clinical safety and pharmacovigilance strategy for assigned oncology assets in alignment with global business objectives - Lead safety governance activities, ensuring appropriate escalation, communication, and resolution of emerging safety issues - Anticipate, identify, and address safety signals, ensuring effective and timely implementation of risk mitigation strategies - Provide strategic recommendations on benefit-risk profiles to support development and lifecycle management decisions

- Exercise expert scientific judgment in the evaluation and interpretation of complex safety data - Lead safety data analyses and signal detection activities, ensuring scientifically robust conclusions and documentation - Guide causality assessments, benefit-risk evaluations, and safety evidence generation across the portfolio - Serve as a recognized subject matter expert in pharmacovigilance methodologies and regulatory expectations

- Oversee proactive identification and assessment of safety signals from clinical trials, post-marketing data, and real-world evidence - Develop and implement risk management strategies, including labeling updates, risk minimization measures, and stakeholder communication plans - Partner closely with safety physicians and cross-functional teams to ensure comprehensive safety oversight

- Lead and influence global, matrixed teams to ensure alignment and execution of safety strategies - Build strong collaborative relationships across clinical, regulatory, medical, and commercial functions - Contribute to due diligence activities, including safety assessments for business development opportunities - Demonstrate agility and resilience in a dynamic, fast-paced environment

- Provide strategic oversight and input into regulatory safety documents and responses to Health Authorities - Ensure compliance with global pharmacovigilance regulations (e.g., ICH, GVP, CIOMS) - Represent safety function in governance forums and external engagements as needed - Drive clear, concise, and influential communication with internal and external stakeholders

Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

- Advanced degree in a relevant scientific or healthcare discipline (e.g., PhD, PharmD, RN/BSN/MSN, NP, RPh, or equivalent) - Significant experience (7+ years) in pharmacovigilance and drug safety within the pharmaceutical or biotech industry - Deep expertise in clinical safety across drug development and post-marketing environments - Demonstrated experience in:

- Signal detection and evaluation - Benefit-risk assessment and safety decision-making - Risk management strategy development

- Strong knowledge of global pharmacovigilance regulations (ICH, GVP, CIOMS) - Experience working in complex, global matrix organizations - Proven ability to influence decisions and lead safety strategy at a program or portfolio level

Preferred Qualification If you have the following characteristics, it would be a plus:

- Prior leadership experience in a global SERM or safety function. - Experience with regulatory interactions and inspections in the US and other regions. - Familiarity with pharmacoepidemiology, real-world evidence, or biostatistics approaches. - Experience preparing Development Core Safety Information, PBRERs or DSURs. - Oncology therapeutic area expertise

- Experience leading global safety teams or major programs - Experience interacting directly with Health Authorities and regulatory submissions - Track record of influencing senior leadership and governance bodies - Demonstrated success in mentoring and developing scientific talent

Ready to apply? If this role aligns with your skills and ambition, please submit your application. We look forward to learning how you can help us get ahead of disease together.

Skills Digital Fluency, Enterprise Leadership, Influencing Without Authority, Pharmacovigilance, Presentation Techniques

- If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $217,800 to $363,000. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role.

In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.