Medical Director, Oncology Clinical Development
GSK
5 months ago
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
On-site office presence for a minimum of two days a week is required in one of the following campuses: UK (London or Stevenage), US (PA or MA), Switzerland (Zug), Poland (Warsaw), or Canada (Mississauga).
Key Responsibilities:
- Collaborate with physicians, scientists, regulatory professionals, biostatisticians, executive staff, and others to develop and execute phase 1-3 interventional clinical trials.
- Ensure high-quality protocol development aligned with the Clinical Development Plan (efficacy, safety, product differentiation, and patient value).
- Provide end-to-end medical expertise (protocol concept to final study report) to ensure scientific integrity, timely trial delivery, regulatory consistency, reimbursable medicines, lifecycle management, and incorporation of global considerations.
- Interpret and summarize study results to define safety, efficacy, PK/PD, and patient-reported outcomes, and assess applicability to the targeted patient population.
- Assume medical responsibility for clinical trials, including real-time medical monitoring (patient eligibility, study design questions, urgent safety questions; including Safety/PV as relevant).
- Oversee medical review of clinical trial data (directly and/or via oversight of delegated review); oversee blinded review of IDMC-intended data packages.
- Review/monitor safety data in collaboration with pharmacovigilance for active studies.
- Author clinical study reports and regulatory documents and respond to health authority and ethics committee queries with Regulatory Affairs, CMC, Toxicology, Research, and Pharmacology.
- Collaborate with Principal Investigators on evaluation of publications (abstracts, posters, manuscripts).
- Network to develop long-term strategic partnerships with internal/external thought leaders.
- Understand biological mechanisms, clinical strategy, scientific interpretation of disease, and target-based literature.
- Serve as a core member of the Clinical Matrix Team for one or more assets.
- Represent Clinical Development on disease area strategy, integrated evidence, and medical affairs strategy teams.
- Participate in Oncology Clinical Development-wide initiatives and workstreams.
Basic Qualifications (Required):
- Medical degree with board certification/eligibility or registration qualifications in medical oncology, hematology, hematology/oncology, gynecologic oncology, general surgery, or internal medicine.
- Oncology or gynecologic oncology experience in pharmaceutical/biotechnology industry, clinical academic medicine, or clinical medical practice.
- Oncology clinical drug development process experience in conducting/participating in clinical trials (investigator-initiated, company-sponsored, or cooperative group trials).
Preferred Qualifications:
- Oncology clinical research and drug development experience focused on GYN cancer, breast cancer, or other solid tumors.
- Regulatory experience supporting registration and GCP principles.
- Strong knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends, and treatment guideline evolution.
Benefits (explicitly stated):
- Annual bonus; eligibility for share-based long-term incentive program (dependent on role level).
- Health care and other insurance benefits (employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
Compensation (explicitly stated, location-dependent):
- If based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA: annual base salary range $222,750 to $371,250.
- Poland base salary range: PLN 455,250 to PLN 758,750 gross (plus possible bonus/awards and statutory benefits per law).
Application Instructions:
- Contact recruitment staff for accommodation or assistance to apply: usrecruitment.adjustments@gsk.com
Key Responsibilities:
- Collaborate with physicians, scientists, regulatory professionals, biostatisticians, executive staff, and others to develop and execute phase 1-3 interventional clinical trials.
- Ensure high-quality protocol development aligned with the Clinical Development Plan (efficacy, safety, product differentiation, and patient value).
- Provide end-to-end medical expertise (protocol concept to final study report) to ensure scientific integrity, timely trial delivery, regulatory consistency, reimbursable medicines, lifecycle management, and incorporation of global considerations.
- Interpret and summarize study results to define safety, efficacy, PK/PD, and patient-reported outcomes, and assess applicability to the targeted patient population.
- Assume medical responsibility for clinical trials, including real-time medical monitoring (patient eligibility, study design questions, urgent safety questions; including Safety/PV as relevant).
- Oversee medical review of clinical trial data (directly and/or via oversight of delegated review); oversee blinded review of IDMC-intended data packages.
- Review/monitor safety data in collaboration with pharmacovigilance for active studies.
- Author clinical study reports and regulatory documents and respond to health authority and ethics committee queries with Regulatory Affairs, CMC, Toxicology, Research, and Pharmacology.
- Collaborate with Principal Investigators on evaluation of publications (abstracts, posters, manuscripts).
- Network to develop long-term strategic partnerships with internal/external thought leaders.
- Understand biological mechanisms, clinical strategy, scientific interpretation of disease, and target-based literature.
- Serve as a core member of the Clinical Matrix Team for one or more assets.
- Represent Clinical Development on disease area strategy, integrated evidence, and medical affairs strategy teams.
- Participate in Oncology Clinical Development-wide initiatives and workstreams.
Basic Qualifications (Required):
- Medical degree with board certification/eligibility or registration qualifications in medical oncology, hematology, hematology/oncology, gynecologic oncology, general surgery, or internal medicine.
- Oncology or gynecologic oncology experience in pharmaceutical/biotechnology industry, clinical academic medicine, or clinical medical practice.
- Oncology clinical drug development process experience in conducting/participating in clinical trials (investigator-initiated, company-sponsored, or cooperative group trials).
Preferred Qualifications:
- Oncology clinical research and drug development experience focused on GYN cancer, breast cancer, or other solid tumors.
- Regulatory experience supporting registration and GCP principles.
- Strong knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends, and treatment guideline evolution.
Benefits (explicitly stated):
- Annual bonus; eligibility for share-based long-term incentive program (dependent on role level).
- Health care and other insurance benefits (employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
Compensation (explicitly stated, location-dependent):
- If based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA: annual base salary range $222,750 to $371,250.
- Poland base salary range: PLN 455,250 to PLN 758,750 gross (plus possible bonus/awards and statutory benefits per law).
Application Instructions:
- Contact recruitment staff for accommodation or assistance to apply: usrecruitment.adjustments@gsk.com