Senior Clinical Research Director

Role: Senior Clinical Research Director (sCRD)

Role responsibilities:
- Report to Global Project Head (GPH) or Principal Clinical Lead (PCL); collaborate with CRDs, Pharmacovigilance, Regulatory, and key functions.
- Provide medical expertise for clinical studies (except select Exploratory Pharmacology) and registries (protocol, key results, Clinical Study Report).
- Support clinical development activities (pressure testing/cluster feasibility, medical review/validation of data, study risk assessment).
- Contribute to Extended Synopsis and Protocol; develop clinical submission dossier content (CTD for FDA/EMA, Japan/China filings, responses to health authority questions).
- Provide medical input/training support for feasibility, medical review, study-team medical information, and investigator support.
- Lead clinical development planning: clinical development plans and IDP clinical sections; resolve study issues; raise issues to GPH/PCL; contribute to product value proposition (TVP), TPP, market access strategy, and clinical research strategy; evaluate medical literature and competitive products.
- Oversee execution: review/validate protocol/amendments, ICF/WSI and TDF; ensure GCP/law/SOP-compliant execution via timelines/budgets/contingency & risk plans; lead study committees; co-develop SAP; key results preparation; develop Clinical Study Report.
- As needed: develop abbreviated protocol/final protocol amendments; feasibility medical support; clinical input across study documents (subject information, CRF, e-diary, monitoring plan); review/approve study documents; support investigator meeting training; continuous medical review of aggregated data; answer EC/IRB/site medical questions; support trial master file readiness and mandatory training.
- Regulatory/safety documents: review/contribute clinical sections of Investigator’s Brochure, CTA, IND, DSUR, INDAR, DRMP, RMP; contribute BLA/CTD and regulatory meeting briefing packages; ensure regulatory standards; participate in Advisory Committee prep.
- Scientific data evaluation and authorship; contribute to advisory board planning and collaborations; ad hoc in-licensing evaluation; clinical advisor to research teams.

Qualifications/requirements:
- MD (or equivalent).
- Fluent English (spoken and written).
- Medical Oncology or Hematology/Oncology specialist.
- At least 4 years in pharmaceutical industry/biotech clinical development.
- Computer skills.

Required skills/experience:
- Strong clinical development and study methodology expertise; pharmaceutical product development/lifecycle knowledge.
- Excellent scientific/medical expertise; strong verbal/written communication with cross-functional teams and regulators.
- Risk-management approach; ability to negotiate operational resources; fluency in English.
- Teaching/training ability; matrix-model experience; international/intercultural working skills.
- Open-mindedness to apply digital solutions.

Benefits (explicitly stated): Health and wellbeing benefits including high-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.