Executive Director, Oncology Early Clinical Development Lead - GU/Prostate at GSK in Collegeville, PA

Are you excited by leading early-phase oncology clinical development and shaping the translational strategy for cutting-edge GU/Prostate 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 – Gyn/ GU, 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. Waltham. MA or Boston. MA); UK (London or Stevenage); Switzerland (Zug); or Poland (Warsaw).

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.

Translational Research Strategy:

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.

Data Analysis and Interpretation:

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.

Collaboration and Communication:

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.

Leadership:

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.

Qualifications:

Basic Qualifications:

Medical degree and Oncology board certification/eligibility/registration
Clinical and research experience in GYN or Prostate cancer
Strong physician scientist experience in the pharmaceutical industry or robust academic setting in the field of oncology with a focus on early phase clinical trials and translational research
Experience designing and executing early phase clinical studies, including FTIH and POC trials
Experience in Oncology 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

Preferred Qualifications:

PhD in addition to medical degree and Oncology board certification/eligibility/registration

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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