Senior Director, Clinical Development

We are looking for a Senior Director of Clinical Development with deep expertise in immunology to lead the design, execution, and management of clinical programs. This leadership role will involve the development of strategic clinical plans, oversight of clinical trials, and ensuring compliance with regulatory requirements throughout all stages of development, from early-phase trials through to later-stage studies.

Key Responsibilities:

Clinical Strategy & Development:

• Develop and implement clinical development strategies that align with organizational goals, ensuring timely delivery of clinical trials from early to late-stage development.
• Collaborate with cross-functional teams to create clinical development plans that meet business objectives and address critical scientific and clinical challenges.
• Manage the clinical trial lifecycle from protocol design and execution through to reporting results.

Trial Design & Oversight:

• Lead the design and execution of clinical trials across multiple therapeutic areas in immunology, ensuring high-quality data collection and analysis.
• Monitor the progress of clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements.
• Ensure the safety and well-being of clinical trial participants by providing oversight on safety reporting, adverse event management, and risk mitigation.
• Ensure that trials are conducted according to Good Clinical Practice (GCP) and other regulatory standards.

Regulatory Affairs & Compliance:

• Lead regulatory interactions with health authorities, ensuring timely and successful submissions for Investigational New Drug (IND) applications, clinical trial authorizations, and other regulatory submissions.
• Ensure adherence to all regulatory requirements and support regulatory filing strategies.
• Manage the preparation of clinical study reports (CSRs), submission documents, and other necessary regulatory documentation.

Leadership & Team Management:

• Provide leadership, mentorship, and guidance to clinical teams, including clinical research associates (CRAs), medical monitors, clinical operations staff, and other key team members.
• Foster a culture of collaboration, accountability, and innovation within the clinical team and across cross-functional departments.
• Act as a key advisor and subject matter expert in immunology, offering insight and guidance on clinical trial design, regulatory strategies, and data interpretation.

Stakeholder Engagement:

• Build and maintain strong relationships with external partners, including clinical trial sites, key opinion leaders (KOLs), academic collaborators, and service providers.
• Participate in the preparation and presentation of clinical data at internal meetings, scientific conferences, and regulatory bodies.
• Liaise with commercial teams to ensure the clinical program aligns with business objectives and market needs.

Scientific Communication & Data Analysis:

• Ensure that clinical data is effectively communicated to internal and external stakeholders, translating complex scientific results into actionable insights.
• Lead data review meetings, discuss potential trial adjustments, and drive decision-making based on clinical data analysis.
• Collaborate with medical affairs teams to support scientific publications, presentations, and clinical insights.

Qualifications:

• M.D., Ph.D., or equivalent in immunology, rheumatology, or a related field.
• 10+ years of experience in clinical development within the biotech or pharmaceutical industry, with a focus on immunology.
• Extensive experience in Phase I–III clinical trials, including protocol design, regulatory submissions, clinical monitoring, and data analysis.
• Strong working knowledge of GCP, ICH guidelines, and regulatory processes in clinical trials.
• Proven ability to lead and mentor clinical teams, fostering collaboration and innovation in a high-performance environment.
• Excellent communication, leadership, and strategic thinking skills with the ability to influence and collaborate at all levels of the organization.

Preferred Qualifications:

• Experience in cell or gene therapy development and clinical trials.
• Expertise in managing clinical trials for autoimmune or inflammatory diseases.
• In-depth knowledge of regulatory submission processes, including INDs, Clinical Study Reports (CSRs), and interaction with health authorities.
• Experience in managing clinical operations in early-stage biotech environments.