Clinical Development Director, Oncology

Position Summary:
You will lead clinical development activities that advance oncology programs from early studies through regulatory interactions, working with cross-functional teams, external experts, and leadership to design studies, interpret data, and shape clinical strategy.

Please note:
On-site office-based presence 2 to 3 days/week in the US (Waltham, MA or Upper Providence, PA), UK (London or Stevenage), Switzerland (Zug), Poland (Warsaw), or Canada (Mississauga, ON).

Responsibilities:
- Provide clinical leadership for study strategy and design (Phase I–IV), ensuring consistency with the CDP, asset profile, and regulatory expectations (MHRA, HRA, EMA, and other relevant authorities).
- Lead protocol development from concept to final study report; author/review Clinical Study Proposal (CSP), Investigator’s Brochure (IB), and clinical sections of regulatory submissions.
- Ensure study objectives, endpoints, and safety monitoring meet regulatory/ethical/medical governance standards; establish and monitor Go/No-Go criteria.
- Integrate internal and external scientific evidence (literature, conferences, competitor data) to shape strategy and interpret findings.
- Lead clinical matrix teams and collaborate with Clinical Operations, Biostatistics, Clinical Pharmacology, Safety/Pharmacovigilance, Regulatory Affairs, and other stakeholders to deliver studies on time, quality, and budget.
- Provide clinical input to regulatory interactions/submissions (IND/CTA, Scientific Advice, EoP2, MAA/NDA/BLA); prepare briefing materials and support regulatory meetings.
- Oversee clinical safety reporting; support DSURs and expedited reporting; coordinate responses to Ethics Committees/IRBs and IDMCs.
- Drive clinical interpretation for CSRs, publications, abstracts, and external presentations; represent programs externally as required.
- Contribute to process improvements to enhance study quality, efficiency, and data integrity.
- Define clinical elements of protocols; present at governance forums (e.g., Protocol Review Forum).
- Ensure protocol and study documentation reflects input from internal/external experts and upholds patient safety.
- Participate in eCRF design/UAT and advise on analysis and reporting plans.
- Lead in-stream data reviews, interim analyses, and IDMC interactions as needed.
- Provide clinical leadership at Investigator Meetings and for site communications.
- Support publication strategy and external scientific engagement activities.

Basic Qualifications (Required):
- Master’s Degree in a life science, medicine, or equivalent with relevant clinical research experience.
- Demonstrable oncology or immuno-oncology clinical development experience across early and late phases.
- Proven matrix leadership; ability to influence cross-functional stakeholders.
- Knowledge of UK/EU regulatory frameworks (MHRA, HRA, EMA) and international submission processes.
- Strong clinical judgement, data interpretation, and communication across governance and external audiences.
- Minimum 2 years clinical scientist experience (oncology preferred).

Preferred Qualifications:
- Experience with immuno-oncology/advanced oncology modalities and biomarkers.
- Experience with clinical pharmacology, translational medicine, or evidence generation planning.
- Experience driving change and improving processes for study delivery.
- Advanced clinical degree (MD, PhD, PharmD, RN) or equivalent senior clinical research experience.
- Experience with regulatory submissions, Scientific Advice/EoP2 interactions, and safety governance committees (IDMC/ISRC).
- Publication record and conference presentation experience.

Application Instructions:
- If you are ready to lead clinical development that can make a real difference for patients, please apply to join the team.