Director, Clinical Development

Gilead

Dublin, Ireland

Job Description

The Director, Clinical Development will play a key role in the design, execution, and evaluation of Phase 1, 2, and 3 clinical trials, providing subject‑matter expertise in pediatric viral infectious diseases. This role will support the development and registration of novel therapies for pediatric viral diseases and will be responsible for a broad range of clinical development activities within the pediatric virology therapeutic area.

The successful candidate will collaborate across multiple functions to support clinical trial start‑up, execution, and close‑out, and will contribute clinical development expertise to data analysis, regulatory submissions, publications, and scientific presentations. The role may serve as Pediatric Development Lead for assigned disease areas, molecules, or products.

As Pediatric Development Lead, you will be responsible for shaping, implementing, and executing the pediatric clinical development strategy, ensuring alignment with overall asset development plans and regulatory expectations.

Essential Functions

Provide input into, or lead, the development of pediatric development plans for applicable compounds and products;
Serve as a trusted clinical and scientific advisor to cross‑functional teams to support timely and high‑quality clinical development deliverables;
Lead or contribute to clinical trial protocol design, clinical study reports, and responses to health authority inquiries;
Partner closely with Gilead asset development teams to ensure alignment with overall development strategies;
Provide ongoing clinical oversight for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance;
Lead or support the preparation and review of regulatory documents, investigator brochures, and development plans;
Coordinate the collection and synthesis of ongoing clinical data for internal analysis and review;
Oversee the preparation and/or review of data listings, summary tables, study reports, and scientific presentations;
Present scientific and clinical data at investigator meetings and international scientific conferences;
Ensure compliance with applicable regulatory requirements, industry standards of Good Clinical Practice (GCP), and Gilead SOPs.

Knowledge, Experience & Skills

MD or equivalent medical degree, PharmD, or PhD in a clinical and/or scientific discipline, or equivalent combination of education, training, and experience;
Experience in pediatric medicine and/or pediatric drug development is highly desirable, with direct hands‑on pediatric development experience strongly preferred;
Familiarity with virology, including HIV, viral hepatitis, COVID‑19, or related viral infectious diseases, is preferred;
Pharmaceutical or biotechnology industry experience in clinical development is preferred;
Demonstrated experience working on cross‑functional, matrixed project and program teams within life sciences, healthcare, academia, or consulting environments;
Strong verbal, written, and interpersonal communication skills;
Proven ability to manage complex clinical development projects, balancing multiple priorities and deliverables through influence and leadership;
Strong analytical and problem‑solving capabilities, demonstrated through professional experience and/or academic research;
Thorough understanding of global pharmaceutical regulatory requirements and their impact on the design and execution of clinical trials;
Willingness to travel as required.