Jobs · Healthcare · Pennsylvania

Senior Medical Director, Oncology Clinical Development - GU

GSK · Collegeville, PA · 3 wk ago
Healthcare$284k–$474k/yrFull-time

This role reports to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Senior Medical Director will lead clinical research activities to advance GSK’s oncology portfolio and engage with internal scientific and medical leaders to drive clinical data generation. This position also involves managing relationships with Key External Experts and requires an on-site office presence (minimum of two days a week) at one of GSK’s sites in Switzerland (Zug), Poland (Warsaw), the UK (Stevenage or London HQ), or the US (PA or MA).

Responsibilities

  • Exhibit leadership at the program and cross-functional level, collaborating with physicians, scientists, regulatory professionals, biostatisticians, and executive staff to develop and execute Phase 1-3 interventional clinical trials.
  • Represent Clinical Development on disease area strategy, integrated evidence, and medical affairs strategy teams.
  • Oversee the development of high-quality protocols aligned with the Clinical Development Plan to determine a medicine’s efficacy, safety profile, differentiation, and patient value efficiently.
  • Contribute to the end-to-end clinical trial process (protocol concept to final study report) to ensure scientific integrity and timely delivery, incorporating global considerations into decision-making.
  • Interpret and summarize study results to define safety, efficacy, pharmacokinetic/pharmacodynamic outcomes, and applicability to the targeted patient population.
  • Assume medical responsibility for clinical trials, including real-time medical monitoring, patient eligibility assessment, study design questions, and medical data review.
  • Review and monitor safety data in collaboration with the pharmacovigilance group for active clinical studies.
  • Participate in authoring clinical study reports and regulatory documents, collaborating with Regulatory Affairs, CMC, Toxicology, Research, and Pharmacology to respond to health authority and ethics committee queries.
  • Collaborate with Principal Investigators to evaluate and assess publications (abstracts, posters, manuscripts) associated with clinical data.
  • Develop long-term strategic partnerships with thought leaders internally and externally to support GSK’s vision.
  • Contribute to the clinical and technical diligence assessment of business development opportunities.
  • Understand biological mechanisms, clinical strategy, and scientific interpretation of disease and target-based literature.
  • Represent GSK at medical meetings, advisory boards, and outreach meetings as needed.
  • Serve as a core member of the Clinical Matrix Team for one or more assets in development.
  • Lead Oncology Clinical Development-wide initiatives and workstreams as appropriate.

Requirements

  • Medical degree and completion of advanced specialty training, fellowship, or country-equivalent higher-level qualification in Medical Oncology, Radiation Oncology, Urology, or Internal Medicine (with GU or oncology experience).
  • Experience in the global pharmaceutical/biotechnology industry in the field of GU prostate cancer.
  • Experience leading GU Oncology drug development, including Phase 1, 2, and 3 clinical trial design, initiation, execution, and closure.
  • Academic and/or clinical research publication history or history of medical practice in GU Oncology.

Qualifications

Preferred Qualifications:

  • PhD in addition to a medical degree and completion of advanced specialty training or fellowship.
  • Established relationships with key external experts (KEEs) in medical oncology and credibility within the medical community.
  • Experience in the clinical assessment of business development opportunities to expand a growing portfolio.
  • Thorough knowledge of worldwide regulatory and safety requirements for drug development, research projects, and/or market support.
  • Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends, and treatment guidelines evolution.
  • Highly developed communication and interpersonal skills for engaging senior stakeholders in a matrixed environment.
  • Demonstrated track record of quality decision-making and innovative problem resolution in critical situations.
  • Knowledge of regulatory requirements to support registration, including adherence to GCP principles.

Skills

  • Clinical Data Interpretation
  • Clinical Pharmacology
  • Clinical Trial Designs
  • Clinical Trials Monitoring
  • Digital Fluency
  • Drug Development
  • Drug Regulatory Affairs
  • Evidence-Based Decision Making
  • Executive Presence
  • Hematology and Oncology
  • Learning Agility
  • Matrix Leadership
  • Real World Evidence (RWE)
  • Scientific Presentations
  • Strategic Direction

Pay

  • US (Cambridge, MA; Waltham, MA; Rockville, MD; San Francisco, CA): Annual base salary ranges from $284,250 to $473,750. This range reflects factors such as work location, skills, experience, and education. The role also offers an annual bonus and eligibility for a share-based long-term incentive program.
  • Poland (Warsaw): Annual gross base salary ranges from PLN 593,250 to PLN 988,750. This range accounts for skills, experience, and education. The role may also include an annual bonus and eligibility for a share-based long-term incentive program.

For other locations, compensation details will be discussed during the recruitment process. Salaries vary by country based on skills, experience, education, and market rates.

Similar jobs