GSK
Executive Director, Oncology Early Clinical Development Lead
GSK, Collegeville, Pennsylvania, United States, 19426
Executive Director, Oncology Early Clinical Development Lead
Apply for the
Executive Director, Oncology Early Clinical Development Lead
position at
GSK .
Site:
United States (Upper Providence, PA; Waltham, MA), United Kingdom (London, Stevenage), Switzerland (Zug), Poland (Warsaw)
Posted Date:
Dec 5 2025.
On‑site presence:
2–3 days a week at any of the listed locations.
Position Summary GSK Oncology Clinical Development seeks a highly qualified Executive Director to bridge pre‑clinical research and clinical development, leading a team of Oncology Early Clinical Development Medical Directors and Clinical Scientists. The role enhances translational research strategy, drives early‑phase clinical study design, and ensures regulatory compliance across the portfolio.
Responsibilities Clinical Study Design & Execution
Accountable for the clinical development plans (CDPs) for early‑phase (Phase I/II) protocols, including first‑in‑human trials, dose‑escalation studies, and proof‑of‑concept studies.
Oversee benefit: risk analyses for clinical programs and delegate to physician leadership as needed.
Drive end‑to‑end clinical development strategy, aligning to target medicine profiles (TMP) and integrated evidence plans (IEP).
Lead discussions with regulatory bodies and draft clinical components of submissions (IND, NDA, BLA, MAA).
Act as the single Clinical Development accountability point within Medicine Development/ Early Development Teams and cross‑functional partnerships.
Ensure compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and GSK policies.
Lead the cross‑functional Clinical Matrix Team and provide oncology expertise and customer insight.
Translational Research Strategy
Oversee clinical components of the translational science strategy in partnership with Oncology Early Development Leaders and translational science teams.
Partner with Oncology Tumor Teams (OTTs) to develop translational strategies across assets, driving OTT activities.
Advance translational research and emerging technologies to improve study designs and foster innovation.
Data Analysis and Interpretation
Interpret complex translational and clinical data, consult on safety analyses, and respond to health authority queries.
Author and review abstracts, presentations, and manuscripts for accuracy.
Prepare for governance discussions with cross‑functional teams.
Lead preparation of clinical sections for regulatory filings (IND, study reports, NDA, annual reports).
Provide clinical support for investigator and consultant meetings.
Present study results and translational insights to stakeholders.
Collaboration and Communication
Integrate inputs from research, clinical, medical, scientific, commercial, regulatory, manufacturing, and operations disciplines.
Build and maintain relationships with external experts, academic collaborators, and research organizations.
Collaborate with Principal Investigators and Steering Committees on publications linked to clinical data.
Serve as program medical expert 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.
Guide direct reports toward cross‑functional integration and alignment.
Promote a culture of boldness, speed, integrity, and One Oncology community.
Establish standards for clinical documents and data review processes across Oncology Clinical Development.
Why You? This role offers a unique opportunity to impact the translation of innovative therapies from laboratory to clinic, while shaping early clinical development in a collaborative environment.
Basic Qualifications
Advanced degree required (PhD/PharmD).
Clinical and research experience in oncology.
Experience designing and executing early‑phase clinical trials, including FTIH and POC.
Knowledge of oncology treatment guidelines and drug approval processes in major regions.
Prior experience developing 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.
In‑depth knowledge of GCP, ICH, FDA, EMEA, NICE, and other regulatory guidelines.
Broad experience in data analysis, interpretation, and clinical relevance.
Experience leading matrix teams and motivating high performance.
Strong business acumen.
In‑depth knowledge of medical and drug terminology and pharmacology.
Highly effective communication skills, capable of presenting complex data to all organization levels.
Demonstrated ability to produce clear, accurate scientific communications in compliance with GSK policies.
Track record of quality decision‑making and creative problem‑resolution.
Adaptability to changing environments and priorities.
Commitment to GSK’s clinical development culture.
Understanding of adverse effect detection, investigation, and prevention.
Advanced negotiating and influencing skills.
Salary range varies by location: $242,550–$404,250 (Boston, MA areas) or $220,500–$367,500 (other US locations). Annual bonus and long‑term incentive program eligibility apply. Benefits include health care, retirement, paid holidays, vacation, and leave.
Benefits and Compensation GSK offers a comprehensive benefits program, including health care, retirement plans, paid holidays, vacation, and leave. Annual bonus and share‑based long‑term incentive programs are available depending on role level.
Equal Opportunity Employment GSK is an Equal Opportunity Employer. All qualified applicants 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, military service, or any prohibited basis.
Accessibility If you require accommodation or assistance to apply, contact GSK Service Centre at 1‑877‑694‑7547 (US Toll‑Free) or +1 801 567 5155 (outside US).
Compliance Notice GSK does not accept referrals from employment businesses or agencies. Employment agencies may only refer candidates after obtaining prior written authorization from GSK’s procurement/human resources department. Any actions undertaken without such approval are deemed performed without consent.
Financial Transparency For licensed healthcare professionals in the U.S., GSK may be required to capture and report expenses incurred on your behalf. For more information, visit the Centers for Medicare and Medicaid Services website at https://openpaymentsdata.cms.gov/.
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Executive Director, Oncology Early Clinical Development Lead
position at
GSK .
Site:
United States (Upper Providence, PA; Waltham, MA), United Kingdom (London, Stevenage), Switzerland (Zug), Poland (Warsaw)
Posted Date:
Dec 5 2025.
On‑site presence:
2–3 days a week at any of the listed locations.
Position Summary GSK Oncology Clinical Development seeks a highly qualified Executive Director to bridge pre‑clinical research and clinical development, leading a team of Oncology Early Clinical Development Medical Directors and Clinical Scientists. The role enhances translational research strategy, drives early‑phase clinical study design, and ensures regulatory compliance across the portfolio.
Responsibilities Clinical Study Design & Execution
Accountable for the clinical development plans (CDPs) for early‑phase (Phase I/II) protocols, including first‑in‑human trials, dose‑escalation studies, and proof‑of‑concept studies.
Oversee benefit: risk analyses for clinical programs and delegate to physician leadership as needed.
Drive end‑to‑end clinical development strategy, aligning to target medicine profiles (TMP) and integrated evidence plans (IEP).
Lead discussions with regulatory bodies and draft clinical components of submissions (IND, NDA, BLA, MAA).
Act as the single Clinical Development accountability point within Medicine Development/ Early Development Teams and cross‑functional partnerships.
Ensure compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and GSK policies.
Lead the cross‑functional Clinical Matrix Team and provide oncology expertise and customer insight.
Translational Research Strategy
Oversee clinical components of the translational science strategy in partnership with Oncology Early Development Leaders and translational science teams.
Partner with Oncology Tumor Teams (OTTs) to develop translational strategies across assets, driving OTT activities.
Advance translational research and emerging technologies to improve study designs and foster innovation.
Data Analysis and Interpretation
Interpret complex translational and clinical data, consult on safety analyses, and respond to health authority queries.
Author and review abstracts, presentations, and manuscripts for accuracy.
Prepare for governance discussions with cross‑functional teams.
Lead preparation of clinical sections for regulatory filings (IND, study reports, NDA, annual reports).
Provide clinical support for investigator and consultant meetings.
Present study results and translational insights to stakeholders.
Collaboration and Communication
Integrate inputs from research, clinical, medical, scientific, commercial, regulatory, manufacturing, and operations disciplines.
Build and maintain relationships with external experts, academic collaborators, and research organizations.
Collaborate with Principal Investigators and Steering Committees on publications linked to clinical data.
Serve as program medical expert 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.
Guide direct reports toward cross‑functional integration and alignment.
Promote a culture of boldness, speed, integrity, and One Oncology community.
Establish standards for clinical documents and data review processes across Oncology Clinical Development.
Why You? This role offers a unique opportunity to impact the translation of innovative therapies from laboratory to clinic, while shaping early clinical development in a collaborative environment.
Basic Qualifications
Advanced degree required (PhD/PharmD).
Clinical and research experience in oncology.
Experience designing and executing early‑phase clinical trials, including FTIH and POC.
Knowledge of oncology treatment guidelines and drug approval processes in major regions.
Prior experience developing 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.
In‑depth knowledge of GCP, ICH, FDA, EMEA, NICE, and other regulatory guidelines.
Broad experience in data analysis, interpretation, and clinical relevance.
Experience leading matrix teams and motivating high performance.
Strong business acumen.
In‑depth knowledge of medical and drug terminology and pharmacology.
Highly effective communication skills, capable of presenting complex data to all organization levels.
Demonstrated ability to produce clear, accurate scientific communications in compliance with GSK policies.
Track record of quality decision‑making and creative problem‑resolution.
Adaptability to changing environments and priorities.
Commitment to GSK’s clinical development culture.
Understanding of adverse effect detection, investigation, and prevention.
Advanced negotiating and influencing skills.
Salary range varies by location: $242,550–$404,250 (Boston, MA areas) or $220,500–$367,500 (other US locations). Annual bonus and long‑term incentive program eligibility apply. Benefits include health care, retirement, paid holidays, vacation, and leave.
Benefits and Compensation GSK offers a comprehensive benefits program, including health care, retirement plans, paid holidays, vacation, and leave. Annual bonus and share‑based long‑term incentive programs are available depending on role level.
Equal Opportunity Employment GSK is an Equal Opportunity Employer. All qualified applicants 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, military service, or any prohibited basis.
Accessibility If you require accommodation or assistance to apply, contact GSK Service Centre at 1‑877‑694‑7547 (US Toll‑Free) or +1 801 567 5155 (outside US).
Compliance Notice GSK does not accept referrals from employment businesses or agencies. Employment agencies may only refer candidates after obtaining prior written authorization from GSK’s procurement/human resources department. Any actions undertaken without such approval are deemed performed without consent.
Financial Transparency For licensed healthcare professionals in the U.S., GSK may be required to capture and report expenses incurred on your behalf. For more information, visit the Centers for Medicare and Medicaid Services website at https://openpaymentsdata.cms.gov/.
#J-18808-Ljbffr