Medical Director, Oncology
Company: emd serono
Location: Billerica
Posted on: January 3, 2026
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Job Description:
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. Thats
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.
Keywords: emd serono, Hartford , Medical Director, Oncology, Science, Research & Development , Billerica, Connecticut
