SERM Senior Medical Director, Oncology

As SERM Senior Medical Director, Oncology, you will lead clinical safety and pharmacovigilance strategy for oncology assets within Global Safety. You will oversee rigorous review, interpretation and communication of safety data, ensuring timely identification, escalation and management of safety issues. Working in a global, cross-functional matrix, you will collaborate with senior governance and partner teams to drive evidence-based safety decisions.

You will also mentor SERM colleagues, strengthening safety and risk-management capabilities and supporting their development across the portfolio.

- Provide expert leadership in clinical safety and pharmacovigilance for oncology assets, including signal evaluation, benefit-risk assessment, regulatory submissions and proactive risk-management strategies. - Oversee the review, interpretation and communication of safety data; identify, escalate and manage safety issues through established safety governance forums. - Develop and implement safety strategies, policies and processes aligned with Global Safety operational and strategic plans. - Coach and mentor medical and scientific colleagues in SERM in signal evaluation, risk management, and preparation of regulatory safety deliverables. - Lead within a global, cross-functional matrix, building strong collaborative relationships and influencing internal and external stakeholders on safety topics. - Lead or oversee SERM safety input into due diligence and other key strategic activities, ensuring safety perspectives shape decision-making.

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

- Medical degree, with completion of a formal postgraduate clinical training, residency or specialty training

- Experience in the pharmaceutical or biotechnology industry working in pharmacovigilance or drug safety.

- Experience in clinical safety and pharmacovigilance activities, including evidence generation, benefit-risk assessment, causality assessment and evaluation of safety signals.

- Experience developing and executing safety strategies for products in clinical development.

- Experience with international pharmacovigilance requirements and drug development and approval processes (for example ICH, GVP modules, CIOMS initiatives).

- Experience of leading large matrix organizations and cross-functional teams.

- Experience developing and executing safety strategies for products in clinical development, preferably in Oncology

- Proven record of high-quality, timely decision-making and creative problem-solving in complex or critical safety situations.

- Experience leading or contributing to safety governance activities, such as safety advisory panels and senior governance committees.

- Experience with successful global regulatory filings (e.g., IND/CTA, NDA/BLA, and EMA/MHRA MAAs).

- Recognised expertise in pharmacovigilance regulations and methodologies, and experience contributing to external pharmacovigilance or industry initiatives.

- Excellent verbal and written communication skills, with the ability to influence senior internal and external stakeholders and drive change to implementation.

- Resilience and adaptability, with the ability to adjust priorities in a changing environment while maintaining focus on patient safety and risk reduction.

This role is hybrid. You will be expected to work on site at a US office a minimum of two days per week, with flexibility for remote work for the remainder.

How we work and what we value We put patients first and act with transparency and integrity. We value clear communication, teamwork, and practical problem solving. We welcome applicants from all backgrounds and support inclusion.

We look for people who want to make a meaningful impact on patient health.

Ready to make a difference? If this role speaks to you, please apply now. We look forward to learning how your experience and perspective can help us get ahead of disease together.

Skills Clinical Development, Drug Regulatory Affairs, Evidence Based Decision Making, Good Clinical Practice (GCP), Influencing Without Authority, Learning Agility, People Management, Project Management, Scientific Presentations, Strategic Thinking

- 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 $284,625 to $474,375. 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.