Medical Director, Oncology Clinical Development
GSK
5 months ago
Remote friendly (Collegeville, PA)
United States
Clinical Research and Development
Key Responsibilities
- Collaborate in a matrix environment to develop and execute phase 1-3 interventional clinical trials.
- Ensure high-quality protocol development aligned to the Clinical Development Plan.
- Contribute end-to-end (protocol concept to final study report) to ensure scientific integrity and timely trial delivery.
- Interpret and summarize study results (safety, efficacy, PK/PD, and patient-reported outcomes) for the targeted population.
- Provide real-time medical monitoring responsibilities, including patient eligibility, study design questions, and urgent safety questions.
- Oversee medical review of trial data, including blinded IDMC data package review.
- Review/monitor safety data with pharmacovigilance.
- Author clinical study reports and regulatory documents; respond to health authority/ethics queries.
- Collaborate on clinical publication evaluations; network with thought leaders; serve on Clinical Matrix Team; represent Clinical Development on strategy teams.
Basic Qualifications (Required)
- Medical degree with board certification/eligibility or registration qualifications in specified specialties (e.g., medical oncology/hematology/oncology, gynecologic oncology, general surgery, internal medicine).
- Oncology/gynecologic oncology experience in pharma/biotech, clinical academic medicine, or clinical practice.
- Oncology clinical drug development process experience in clinical trial conduct/participation.
Preferred Qualifications
- Experience focused on GYN/breast cancer or other solid tumors; regulatory experience (registration/GCP); strong disease/market guideline knowledge.
Benefits (explicitly stated)
- Health care/insurance, retirement, paid holidays, vacation, paid caregiver/parental and medical leave.
Application Instructions
- For application assistance: usrecruitment.adjustments@gsk.com.
- Collaborate in a matrix environment to develop and execute phase 1-3 interventional clinical trials.
- Ensure high-quality protocol development aligned to the Clinical Development Plan.
- Contribute end-to-end (protocol concept to final study report) to ensure scientific integrity and timely trial delivery.
- Interpret and summarize study results (safety, efficacy, PK/PD, and patient-reported outcomes) for the targeted population.
- Provide real-time medical monitoring responsibilities, including patient eligibility, study design questions, and urgent safety questions.
- Oversee medical review of trial data, including blinded IDMC data package review.
- Review/monitor safety data with pharmacovigilance.
- Author clinical study reports and regulatory documents; respond to health authority/ethics queries.
- Collaborate on clinical publication evaluations; network with thought leaders; serve on Clinical Matrix Team; represent Clinical Development on strategy teams.
Basic Qualifications (Required)
- Medical degree with board certification/eligibility or registration qualifications in specified specialties (e.g., medical oncology/hematology/oncology, gynecologic oncology, general surgery, internal medicine).
- Oncology/gynecologic oncology experience in pharma/biotech, clinical academic medicine, or clinical practice.
- Oncology clinical drug development process experience in clinical trial conduct/participation.
Preferred Qualifications
- Experience focused on GYN/breast cancer or other solid tumors; regulatory experience (registration/GCP); strong disease/market guideline knowledge.
Benefits (explicitly stated)
- Health care/insurance, retirement, paid holidays, vacation, paid caregiver/parental and medical leave.
Application Instructions
- For application assistance: usrecruitment.adjustments@gsk.com.