Medical Director, Oncology (Billerica MA)

 

Work Your Magic with us! Start your next chapter and join EMD Serono.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role:

As a Medical Director / Clinical Lead in Global Clinical Development Oncology, you will lead the clinical strategy and execution for programs within the Oncogenic Signaling team. You will drive studies from first‑in‑human/early development through potential late‑stage transition, integrating translational and biomarker insights to inform patient selection and go/no‑go decisions. You will provide strategic and medical leadership within cross‑functional teams and the Global Project Team (GPT), operating independently day‑to‑day.

Key Accountabilities:

• Lead clinical programs end‑to‑end: Oversee clinical study plans from Phase 1 through Phase 3 within the Clinical Team; ensure smooth transition from early proof‑of‑concept to late‑stage development where applicable.
• Own clinical strategy for targeted therapies: Design and refine clinical development strategies, including dose selection, expansion cohort rationale, patient enrichment, and registrational pathways.
• Integrate translational data into the clinic: Interpret preclinical and clinical biomarker data (e.g., genomic alterations, pathway activation, resistance mechanisms) to optimize indication selection, eligibility criteria, and combination strategies.
• Author and deliver high‑quality documents: Lead or contribute to clinical plans, study concept sheets, protocols/amendments, IBs, CSRs, clinical sections of regulatory submissions, and publications.
• Medical monitoring & data review: Provide medical oversight for assigned studies, review safety/efficacy data, and contribute to SAPs, DMC/IDMC interactions, and database lock readiness.
• Cross‑functional leadership: Partner effectively with Translational Medicine, Biostatistics, Clinical Pharmacology, Regulatory Affairs, Clinical Operations, Safety, and Commercial/BD.
• Health Authority and governance interactions: Support or lead interactions with FDA/EMA (and possibly Japan and China) and internal governance bodies; contribute to briefing materials and responses to queries.
• Operate across time zones: Work autonomously and communicate proactively to ensure progress with stakeholders in Europe and the US.

 

Who You Are

Minimum Qualifications:

• MD with expertise in clinical drug development.
• ≥3 years of industry experience in clinical R&D within pharma/biotech (early development experience strongly relevant).
• Demonstrated ability to integrate translational/biomarker data into clinical decision‑making for targeted oncology programs.
• Experience working in a matrixed, international environment with cross‑functional teams.
• Clear, concise communicator with excellent written and verbal English skills.
• Comfortable working independently across time zones with proactive alignment and accountability.
• Experience in interactions with Health Authorities; familiarity with