Medical Director, Oncology (Billerica MA) at EMD Serono

Billerica, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Jan, 26

Salary

253900.0

Posted On

06 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Drug Development, Oncology, Translational Data, Biomarker Data, Clinical Strategy, Regulatory Affairs, Cross-Functional Leadership, Medical Monitoring, Data Review, Project Leadership, Analytical Thinking, Strategic Thinking, Communication Skills, Health Authority Interactions, Matrixed Environment, Independent Work

Industry

Pharmaceutical Manufacturing

Description

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 ICH‑GCP and clinical trial regulations. Preferred Qualifications: Background in oncogenic signaling and targeted therapy development (e.g., pathway inhibitors, precision oncology). Experience designing and executing FIH/Phase 1 expansion, PoC trials and transitioning to Phase 2/3. Familiarity with R&D interface partners (Regulatory, Clin Pharm, Biostats, Translational Medicine). Project leadership skills with a track record of driving timelines and decision points. Strong analytical and strategic thinking; thrives in dynamic settings and can manage multiple priorities. Board certification in Medical Oncology/Hematology (or relevant subspecialty) is a plus. Location: Billerica MA Pay range for this position: $142,500 - $ 253,900 Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Responsibilities

Lead the clinical strategy and execution for oncology programs, overseeing clinical study plans from Phase 1 through Phase 3. Provide strategic and medical leadership within cross-functional teams and ensure smooth transitions from early to late-stage development.