Director, Clinical Science – Oncology Clinical Development
GSK · Waltham, MA · 1 wk ago
RemoteRemoteHealthcare$190k–$316k/yrFull-time
About the role
GSK is committed to transforming outcomes for patients through innovative science, bold ambition, and strong partnerships across the healthcare ecosystem. The Director, Clinical Science – Oncology Clinical Development role is part of this commitment.
Responsibilities
- Provide scientific leadership across defined components of study-level activities, including protocol development, study design, data review, and interpretation, within the strategic direction set by the CDL.
- Serve as a core member of the Clinical Matrix Team (CMT), ensuring scientific alignment across study objectives, timelines, and deliverables.
- Provide scientific insight to the CDL and Senior Scientist to inform asset-level strategy, benefit-risk assessment, and programme-level decision-making.
- Ensure the scientific quality and consistency of key clinical and regulatory documents, including protocols, Investigator’s Brochures, Clinical Study Reports, and submission materials.
- Apply scientific and clinical expertise to analyse and interpret data, ensuring rigour, integrity, and relevance to the target patient population.
- Engage with internal and external stakeholders, including investigators and Key External Experts, to support study execution and scientific exchange.
- Contribute to a culture of scientific excellence, innovation, and continuous improvement within Oncology Clinical Development.
Requirements
- Bachelor’s degree in life sciences or related scientific discipline required.
- 5+ years of experience in pharmaceutical/biotechnology industry or related clinical development experience, with a focus on oncology.
- Experience in clinical development from early stage through to regulatory submission, including study design, protocol authoring, and data review/interpretation.
- Experience working within GCP, ICH, and global regulatory guidelines.
- Experience authoring or contributing to clinical study proposals, protocols, Investigator’s Brochures, informed consent forms, clinical study reports, and regulatory submissions.
- Experience working within cross-functional matrix teams and contributing to clinical decision-making.
- Proven track record of working with investigators, site staff, external experts, CROs, and vendors.
Qualifications
- Advanced degree (e.g. MS, PhD, PharmD) strongly preferred in life sciences or a related discipline.
- Oncology or immuno-oncology clinical development experience.
- Experience presenting or preparing materials for Protocol Review Boards, governance meetings, or scientific forums.
- Knowledge of regulatory requirements to support registration, including experience contributing to IND, EoP2, scientific advice, pre-NDA/BLA, NDA/MAA, or AdCom submissions.
Skills
- Analytical Thinking
- Clinical Data Interpretation
- Clinical Data Review
- Clinical Development
- Clinical Trial Designs
- Clinical Trials Monitoring
- Digital Fluency
- Drug Regulatory Affairs
- Executive Presence
- Hematology and Oncology
- Learning Agility
- Matrix Leadership
- Real World Evidence (RWE)
- Scientific Presentations
Pay
The annual base salary for new hires in this position ranges $189,750 to $316,250.
Schedule
This role is hybrid. You will be on-site at one of the posted locations at least two days per week. Remote work is available on other days.