Medical Director, Oncology Clinical Development
GSK
1 month ago
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
Medical Director, Oncology Clinical Development
On-site presence: 2 to 3 days/week in the UK (London or Stevenage); Switzerland (Zug); US (Upper Providence, PA or Waltham, MA); or Poland (Warsaw).
Key Responsibilities:
- Collaborate in a matrix environment to develop and execute phase 1–3 interventional clinical trials.
- Ensure high-quality protocol development aligned with the Clinical Development Plan (efficacy, safety, differentiation, patient value).
- Contribute end-to-end (protocol concept to final study report) to ensure scientific integrity, timely delivery, and alignment with clinical development strategy for regulatory approvals and lifecycle management; incorporate global considerations.
- Interpret and summarize study results to define safety, efficacy, PK/PD, and patient-reported outcomes and applicability to the target population.
- Provide medical responsibility with real-time medical monitoring (eligibility, study design questions, urgent safety questions; Safety/PV as relevant).
- Oversee medical review of trial data (directly and/or delegated); oversee blinded review for IDMC data packages.
- Review/monitor safety data with the pharmacovigilance group.
- Author clinical study reports and regulatory documents; respond to health authority and ethics committee queries with Regulatory Affairs, CMC, Toxicology, Research, Pharmacology.
- Collaborate with Principal Investigators on evaluation of publications (abstracts, posters, manuscripts).
- Network to develop long-term strategic partnerships with thought leaders.
- Understand biological mechanisms and target-based literature; serve on Clinical Matrix Team; represent clinical development on strategy teams; participate in Oncology Clinical Development initiatives.
Basic Qualifications:
- Medical degree with board certification/eligibility or registration qualifications in medical oncology, hematology, hematology/oncology, general surgery, internal medicine, or pathology.
- Oncology experience (pharma/biotech industry, clinical academic medicine, or clinical practice).
- Experience conducting/participating in clinical trials (investigator-initiated, company-sponsored, or cooperative group) and their publications.
Preferred Qualifications:
- Board/registration qualification in medical oncology, hematology, or pathology.
- Board/registration certified or eligible physician with a PhD.
- Experience in Lung or Head & Neck Oncology clinical trials (study design, data review/interpretation, overall clinical development process).
- Experience with regulatory requirements to support registration; GCP knowledge.
- Deep knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical trends, and treatment guideline evolution.
On-site presence: 2 to 3 days/week in the UK (London or Stevenage); Switzerland (Zug); US (Upper Providence, PA or Waltham, MA); or Poland (Warsaw).
Key Responsibilities:
- Collaborate in a matrix environment to develop and execute phase 1–3 interventional clinical trials.
- Ensure high-quality protocol development aligned with the Clinical Development Plan (efficacy, safety, differentiation, patient value).
- Contribute end-to-end (protocol concept to final study report) to ensure scientific integrity, timely delivery, and alignment with clinical development strategy for regulatory approvals and lifecycle management; incorporate global considerations.
- Interpret and summarize study results to define safety, efficacy, PK/PD, and patient-reported outcomes and applicability to the target population.
- Provide medical responsibility with real-time medical monitoring (eligibility, study design questions, urgent safety questions; Safety/PV as relevant).
- Oversee medical review of trial data (directly and/or delegated); oversee blinded review for IDMC data packages.
- Review/monitor safety data with the pharmacovigilance group.
- Author clinical study reports and regulatory documents; respond to health authority and ethics committee queries with Regulatory Affairs, CMC, Toxicology, Research, Pharmacology.
- Collaborate with Principal Investigators on evaluation of publications (abstracts, posters, manuscripts).
- Network to develop long-term strategic partnerships with thought leaders.
- Understand biological mechanisms and target-based literature; serve on Clinical Matrix Team; represent clinical development on strategy teams; participate in Oncology Clinical Development initiatives.
Basic Qualifications:
- Medical degree with board certification/eligibility or registration qualifications in medical oncology, hematology, hematology/oncology, general surgery, internal medicine, or pathology.
- Oncology experience (pharma/biotech industry, clinical academic medicine, or clinical practice).
- Experience conducting/participating in clinical trials (investigator-initiated, company-sponsored, or cooperative group) and their publications.
Preferred Qualifications:
- Board/registration qualification in medical oncology, hematology, or pathology.
- Board/registration certified or eligible physician with a PhD.
- Experience in Lung or Head & Neck Oncology clinical trials (study design, data review/interpretation, overall clinical development process).
- Experience with regulatory requirements to support registration; GCP knowledge.
- Deep knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical trends, and treatment guideline evolution.