Cpl

About the Company

Cpl is a global provider of talent solutions to startup companies, multinationals, and SMEs in every sector from Pharmaceuticals to Fund Accounting.

Founded in 1989, Cpl employs over 14,000 people and has 50 office locations operating in 14 countries worldwide including Ireland, The United Kingdom, Belgium, Bulgaria, The Czech Republic, Germany, Hungary, Poland, Slovakia, The United States, and Australia.

Matching the right talent to the right organisation is the core guiding principle in everything we do.

Listed Jobs

Company Name

Cpl

Job Title

Clinical Development Director

Job Description

**Job Title:** Clinical Development Director **Role Summary:** Lead strategic and scientific oversight of global clinical development programs across neurology, immunology, and cardiology. Manage all phases of clinical trials—from protocol design to data interpretation—while ensuring regulatory compliance, inspection readiness, and effective stakeholder engagement. **Expectations:** - Deliver scientific leadership and strategy for live studies. - Collaborate tightly with cross‑functional teams (data management, biostatistics, medical affairs, regulatory). - Engage with external stakeholders: CROs, regulatory agencies, KOLs, advisory boards. - Maintain oversight of safety monitoring, risk management, and benefit‑risk assessments. - Ensure documentation meets regulatory requirements and supports audit readiness. **Key Responsibilities:** 1. Author, review, and approve clinical trial protocols, investigator brochures, and study reports. 2. Oversee medical monitoring and clinical data review to ensure data integrity and safety. 3. Contribute to global regulatory submissions, responses, and communication. 4. Provide strategic input into clinical development plans and translational strategies. 5. Lead inspection readiness efforts, GCP audit preparation, and compliance initiatives. 6. Develop and supervise publication strategies and scientific communications. 7. Mentor and support the development of clinical team members within a matrix structure. 8. Collaborate with external CROs and regulatory bodies to align study objectives and timelines. **Required Skills:** - Expertise in at least one therapeutic area: neurology, immunology, or cardiovascular. - Proven experience authoring clinical protocols, investigator brochures, and study reports. - Strong understanding of safety data evaluation, risk‑management, and benefit‑risk assessment. - Experience contributing to global regulatory submissions and regulatory interactions. - Ability to lead cross‑functional teams and engage external stakeholders. - Familiarity with GCP audits, inspection readiness, and regulatory compliance. - Excellent written and verbal communication skills. - Leadership and mentorship capability in a matrix environment. **Required Education & Certifications:** - Advanced degree preferred (Masters or PhD in Life Sciences, Medicine, Pharmacy, or related field). - Clinical trial oversight experience from early to late phase. - Knowledge of regulatory guidelines (FDA, EMA, ICH) and GCP standards. ---

London, United kingdom

On site

03-10-2025