Director, Clinical Science – Oncology Clinical Development
$189,750–$316,250 year
On-siteWarsaw, Mazovia, Poland or Waltham, Massachusetts, United States
Job Summary
Provide scientific leadership across study-level activities, including protocol development, study design, data review, and interpretation within the strategic direction set by the Clinical Development Lead. Serve as a core member of the Clinical Matrix Team to ensure scientific alignment across study objectives and deliverables. Author or co-author key study documents such as Clinical Study Proposals, Investigator's Brochures, and Clinical Study Reports while ensuring data integrity and regulatory compliance. Analyze clinical data to generate insights on safety, efficacy, and patient populations, translating findings into clear scientific insights to inform programme progression and decision-making. Engage with internal and external stakeholders, including investigators and Key External Experts, to support study execution and scientific exchange. Identify scientific and operational risks at the study level and provide input into mitigation strategies. This individual contributor role requires deep oncology clinical development expertise and operates within a complex, matrixed environment.
Required Qualifications
- Bachelor's degree in life sciences or related scientific discipline
- 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
- Working model: 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
Desired Qualifications
- Advanced degree (e.g. MS, PhD, PharmD) strongly preferred in life sciences or a related discipline
- Clinical development experience across multiple phases of development (Phase I–IV)
- GU 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
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