Job Title: Senior Director, Clinical Development
Department: Clinical Development
Location: United Kingdom - Remote
Reports To: Chief Medical Officer
About Us
Our client is a leading biotechnology company specializing in the discovery, development, and commercialization of innovative therapies for transplant medicine and autoimmune diseases, with a specific focus on rheumatology. Our mission is to improve patient outcomes and quality of life by advancing groundbreaking science and delivering novel treatments.
Position Summary
The Senior Director of Clinical Development will lead the strategy, planning, and execution of clinical development programs for our innovative pipeline in transplantation and/or rheumatology. As a key member of the clinical leadership team, you will work cross-functionally to drive the development of clinical strategies, oversee the design and implementation of clinical trials, and ensure regulatory compliance. This role requires a visionary leader with deep therapeutic expertise, a track record of successful drug development, and the ability to navigate the complexities of the biotech environment.
Key Responsibilities
Strategic Leadership
* Develop and implement clinical development strategies aligned with corporate objectives, focusing on transplantation and/or rheumatology programs.
* Provide expert guidance on the design and execution of clinical trials, including Phase I-IV studies.
* Collaborate with senior leadership to define program priorities, timelines, and resource allocation.
* Serve as the clinical development lead in meetings with external stakeholders, including regulatory authorities, key opinion leaders, and strategic partners.
Clinical Program Execution
* Oversee the development of clinical protocols, investigator brochures, and clinical study reports.
* Lead cross-functional teams to ensure timely and efficient execution of clinical studies within budget.
* Monitor clinical trial progress, addressing any operational or scientific challenges that arise.
* Drive biomarker strategy and translational research efforts in collaboration with research teams.
Regulatory and Compliance
* Serve as the clinical development representative for regulatory submissions, including INDs, CTAs, and NDAs/BLAs.
* Ensure all clinical activities comply with ICH-GCP guidelines, FDA, EMA, and other regulatory requirements.
* Engage with regulatory agencies to address questions, present data, and gain alignment on development plans.
Cross-Functional Collaboration
* Partner with preclinical, regulatory, CMC, and commercial teams to align clinical strategies with broader corporate goals.
* Act as a mentor to clinical development staff, fostering a culture of collaboration, innovation, and scientific excellence.
* Build and maintain relationships with investigators, patient advocacy groups, and external partners.
Qualifications
* MD, PhD, or equivalent advanced degree in life sciences or medicine.
* Minimum of 10-15 years of experience in clinical development, with at least 5 years in a leadership role in the biotech or pharmaceutical industry.
* Deep expertise in transplant medicine, rheumatology, or autoimmune diseases.
* Proven track record of designing and executing clinical trials, from concept to regulatory submission.
* Strong understanding of regulatory requirements, including FDA and EMA guidelines.
* Excellent leadership, communication, and interpersonal skills.
* Demonstrated ability to work in a fast-paced, matrixed environment.
* Experience with biomarkers and translational research is highly desirable.
Why Join Us?
* Be part of a passionate and collaborative team dedicated to transforming the lives of patients.
* Opportunity to shape the development of innovative therapies in high-impact therapeutic areas.
* Competitive compensation and benefits package, including equity participation.
* Work in a dynamic environment where your contributions will directly influence corporate success and patient care.