Clinical Research Director

The Clinical Research Director (CRD) is a key clinical lead in the development of R&D programs.

Responsibilities / Key Responsibilities
- Collaborate with DMDs/DSDs and Global Project leadership to deliver development strategy and support regulatory body interactions.
- Provide clinical scientific expertise across study teams from early phases through LCM programs.
- Develop study-level regulatory documentation (Abbreviated Protocol, Protocol, protocol amendments) and lead study-start-up operational activities (e.g., pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment).
- Provide clinical input/support for study conduct (IRB/HA questions, protocol medical training, medical review/centralized monitoring input, information for advisors/Clinical Project Leaders/investigators).
- Contribute clinical sections to the Common Technical Document (CTD) and answer health authority questions.
- Ensure medical relevance of clinical data; serve as scientific/medical reference for the study team.
- Lead/support/oversee execution of clinical development and trial activities, ensuring compliance with GCP, laws/regulations, and SOPs; manage timelines, budgets, and risk.
- Develop/review CSICF and study committee charters; participate in feasibility/competitive intelligence collaboration.
- Review clinical input across study documents (e.g., RFPs, eCRF, e-diary, eCoA); support training at investigator/local team meetings.
- Answer medical questions from HA, EC/IRBs, and sites; ensure data quality (continuous validation, blinded review).
- Lead study-specific committees (IDMC, steering committee, adjudication); co-develop SAP with biostats; prepare key results.
- Review/contribute to regulatory and safety documents (Investigator’s brochure, CTA, IND, DSUR, DRMP, RMP) and contribute to BLA/CTD, briefing packages, PSP/PIP; detect/document safety signals with Patient Safety GSO; support Advisory Committee preparation.
- Author manuscripts/abstracts; establish collaborations; serve as clinical advisor for research teams/ad hoc tasks (e.g., in-licensing candidate evaluation).

Experience / Qualifications (Minimum)
- MD with specialization in dermatology or allergology, or GP with dermatology development experience.
- At least 3 years in Clinical or Pharmaceutical industry experience (Atopic Dermatitis or Hidradenitis suppurativa preferred).
- Previous experience in clinical development.

Required/Preferred Skills
- Strong scientific/medical and clinical development expertise; clinical study methodology knowledge.
- Very good communication (verbal/written) with cross-functional teams and regulators.
- Excellent problem solving; challenge status quo with risk-management approach.
- Negotiation skills to secure resources; fluency in written/spoken English; strong teaching ability.
- Ability to work in a matrix model; international/intercultural collaboration; open-mindedness to digital solutions.