Executive Director, Oncology Early Clinical Development Lead

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.

GSK Oncology Clinical Development is seeking a highly skilled and motivated Executive Director, Oncology Early Clinical Development Lead to join our dynamic Oncology Research and Development team. In this role the successful candidate will create a strong link between Clinical Development and Pre-clinical/Discovery teams to improve forward and reverse translation and, thereby, increase the success of our Oncology clinical portfolio. They will be responsible for leading a team of talented Oncology Early Clinical Development Medical Directors and Clinical Scientists who will design and execute early-phase clinical studies, as well as contribute to the translational research strategy for early phase clinical assets. This role offers a unique opportunity to bridge the gap between preclinical research and clinical development, ensuring the successful translation of innovative therapies from the lab to the clinic.

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); Switzerland (Zug) or Poland (Warsaw).

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.
• 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.

Translational Research Strategy

• 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.

Data Analysis and Interpretation

• 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.

Collaboration and Communication

• 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.

Oncology Clinical Development Leadership

• 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.

Basic Qualifications

• 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 Qualifications

• 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.