GSK · 1 month ago
Executive Director, Oncology Early Clinical Development Lead
USA - Massachusetts - Boston
Full-time
Hybrid
Director/Executive
$220K/yr - $368K/yrGSK is a global biopharma company focused on uniting science, technology, and talent to advance health. They are seeking an Executive Director for Oncology Early Clinical Development to lead a team responsible for designing and executing early-phase clinical studies and enhancing the translational research strategy for clinical assets.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Accountable for the clinical development plans (CDPs) for a portfolio of early phase (Phase I/II) clinical study protocols, including first-in-human (FIH) trials, dose-escalation studies, and proof-of-concept (POC) studies
Accountable for overall benefit: risk of a clinical program. If not a physician, the CDL is expected to delegate to and interface closely with the appropriate physician(s) on the program
Accountable for driving the end-to-end clinical development strategy and alignment to target medicine profiles (TMP) and integrated evidence plans (IEP), spanning all phases of development, including trial design, execution, and interpretation and delivery of trial results
Lead clinical development discussions and teams at regulatory interactions and accountable for drafting clinical components of regulatory submissions/files (i.e. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses
Participate as a core member of the Medicine Development Team (MDT) or Early Development Team (EDT) and provide a single Clinical Development accountability at the program level within these teams and other cross-functional partnerships with Medical Affairs, Integrated Evidence, Publications, and Global and Regional Commercial functions
Ensure that all clinical studies are conducted in compliance with applicable regulatory requirements, Good Clinical Practice (GCP) guidelines, and GSK policies and procedures
Lead the cross-functional Clinical Matrix Team and provide clinical leadership, Oncology Clinical Development expertise, and customer insight for the program
Oversee the development and execution of the clinical development components of the overall translational science strategy in partnership with Oncology Early Development Leaders, Oncology Translational Science, pre-clinical Oncology Research teams (ETCT & ITCT), AI/ML, Clinical Pharmacology & Experimental Medicine, Research Technologies
Partner with the Oncology Tumor Teams (OTTs) to develop the translational strategy across assets within a given tumor and drive OTT activities with a clinical and translational focus
Drive advancements in translational research and emerging technologies to improve study designs and foster innovation
Interpret complex translational and clinical data and identify trends for clinical and regulatory documents consult on safety analyses, and responses to health authority queries
Author and/or review abstracts, presentations and manuscripts for accuracy of clinical data, interpretation, and content
Prepare for governance discussions in close collaboration with cross-functional Early Development or Medicine Development Team and other business lines
Lead preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, annual reports, etc.)
Lead and provide clinical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards)
Present study results and translational insights to internal and external stakeholders, including senior management, scientific advisory boards, and regulatory agencies
As a therapy area subject matter expert, accountable for integrating inputs from across disciplines (research, clinical, medical, scientific, commercial, regulatory, manufacturing, operations, etc.) to ensure alignment and successful execution of translational research initiatives
Build and maintain strong relationships with key external experts (KEEs), academic collaborators, and external research organizations, including the Oncology Translational Network
Collaborate with Principal Investigators and Steering Committees in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data
Serve as program medical experts for internal and external collaborators, investigators, and consultants
Lead, coach and mentor a team of Oncology Early Clinical Development Medical Directors and Clinical Scientists. Provide direct reports with ongoing coaching, development and leadership; includes holding regular staff meetings, check-ins and 1:1 meetings
Guide direct reports to ensure cross-functional integration, coordination, collaboration, and alignment to enable effective and efficient CDP and translational strategy execution
Foster the development of our culture within the team of direct reports: be bold, be swift, act with integrity, as a One Oncology community
Contribute to the establishment of standards for clinical documents and data review processes across Oncology Clinical Development
Qualification
Required
Advanced degree Required, PhD/PharmD
Clinical and Research Experience in Oncology
Pharmaceutical or relevant scientific/medical/clinical experience in Oncology with focus on designing and executing early phase clinical trials, including FTIH and POC, and translational research
Experience with Oncology treatment guidelines, clinical development process and drug approval process in major regions
Prior experience developing and driving translational strategy: biomarker, companion diagnostic, PK/ PD modeling and simulation
Preferred
MD Preferred
Board certification/eligibility or clinical experience in oncology
Experience in the gastro-intestinal therapeutic area highly preferred
In-depth knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
Experience leading matrix teams with a strong reputation of inspiring and motivating high performance
Strong business acumen
In depth knowledge of medical and drug terminology and a sound foundation in pharmacology
Highly effective communication skills; able to present complex data, design, strategy to groups at all levels of the organization
Demonstrated ability to produce written scientific communications with clarity, accuracy and rigor and in compliance with GSK control documents governing disclosure, publication and principles of scientific exchange
Demonstrated track record of quality decision making and creative problem resolution in critical situations, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context
Ability to adjust behaviors and priorities based on changing environment and dynamics
Ability to engage in, and contribute to, Oncology Clinical Development Culture and broad GSK environment with confidence, impact, integrity and professionalism
Demonstrated understanding of the detection, investigation, assessment and prevention of adverse effects of medicines on patients
Highly developed negotiating and influencing skills. Ability to influence others to make sound decisions from a clinical perspective
Benefits
Annual bonus
Eligibility to participate in our share based long term incentive program
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave
Company
GSK
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
Founded in 1929
10001+ employees
H1B Sponsorship
GSK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Julie Brown
CFO
Mike Elmore
SVP & Chief Information Security Officer, GSK
Recent News
South China Morning Post
2026-01-08
2026-01-07
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