Executive Director, Oncology Early Clinical Development Lead - Heme
Posted Date: Aug 5 2025 Are you a physician leader excited by leading early-phase oncology clinical development and shaping the translational strategy for cutting-edge Hematology therapies? If so, the Executive Director, Oncology Early Clinical Development Lead may be an ideal opportunity to explore. GSK ONCOLOGY GSK's ambition is to help increase overall quality of life, maximize survival and change the course of disease, expanding from our current focus on blood and women's cancers into lung and gastrointestinal cancers, as well as other solid tumors. Accelerated research areas including tumor-cell targeting therapies and next generation immuno-oncology agents, drawing internal capabilities, expertise in human genetics and the science of the immune system, as well as that of GSK's partners. Multiple investigational medicines in GSK's oncology pipeline that have the potential to make a meaningful difference for patients with cancer, and we continue to grow the pipeline through targeted business development. GSK Oncology Clinical Development seeks an Executive Director, Oncology Early Clinical Development Lead to drive the successful translation of therapies from preclinical research to clinical development. Reporting into the VP, Oncology Clinical Development - Heme, this role involves leading a team of Medical Directors and Clinical Scientists to design and execute early-phase studies while enhancing collaboration between Clinical Development and Preclinical/Discovery teams to optimize translational research strategies and advance GSK's Oncology portfolio. Please note: This position requires an on-site office-based presence 2 to 3 days a week in the US (Upper Providence, PA. or Waltham. MA.); UK (London or Stevenage); or Switzerland (Zug). Key responsibilities : Clinical Study Design & Execution:
- Develop clinical development plans (CDPs) for a portfolio of Phase I/II trials, including first-in-human, dose-escalation, and POC studies.
- Accountable for driving the end-to-end clinical development strategy and ensuring alignment to target medicine profiles (TMPs) and integrated evidence plans (IEPs) across all phases of development.
- Lead clinical strategy discussions at regulatory interactions and accountable for drafting clinical components of regulatory submissions (e.g., IND, NDA, BLA).
- Serve as a core member of the Medicine Development Team (MDT)/Early Development Team (EDT), providing single clinical development accountability at the program level.
- Ensure compliance with regulatory requirements, GCP guidelines, and GSK policies.
- Collaborate with teams across Oncology Research, Preclinical, Translational Science, AI/ML, and Clinical Pharmacology to develop and execute translational research strategies.
- Partner with Oncology Tumor Teams (OTTs) to advance translational strategies across assets and drive innovation in study designs.
- Interpret clinical and translational data to guide regulatory documents, safety analyses, and health authority responses.
- Author and/or review clinical data publications, abstracts, and presentations.
- Lead preparation of clinical sections for regulatory filings and governance discussions.
- As a therapy area subject matter expert, be accountable for integrating inputs from cross-disciplinary teams to ensure alignment on translational research initiatives.
- Build and maintain relationships with key external experts, academic collaborators, and research organizations, including the Oncology Translational Network.
- Serve as program medical expert for internal and external stakeholders.
- Lead, mentor, and coach a team of Oncology Early Clinical Development Medical Directors and Clinical Scientists.
- Drive cross-functional integration, alignment and collaboration to execute CDPs and translational strategies effectively.
- Foster a bold, swift, and integrity-driven culture within the team while contributing to standardized processes in Oncology Clinical Development.
- Medical degree and Oncology board certification/eligibility/registration
- Clinical and research experience in Hematology.
- Strong physician scientist experience in the pharmaceutical industry or robust academic setting in the field of hematology/oncology with a focus on early phase clinical trials and translational research in hematology
- Experience designing and executing early phase clinical studies, including FTIH and POC trials
- Experience in hematology treatment guidelines, therapeutic competitive landscape, clinical development process and drug approval process in major regions
- Experience developing and driving translational strategy: biomarker, companion diagnostic, PK/ PD modeling and simulation
- Experience managing direct reports and leading matrix teams
- Global regulatory experience
- Medical degree and Hematology board certification/eligibility/registration
- PhD in addition to medical degree and Oncology/Hematology board certification/eligibility/registration
- Experience in multiple myeloma, myeloproliferative disease spectrum, AML, MDS and MF.
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