Director, Clinical Development

Job Description

The Director, Clinical Development, will help design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide expertise on pediatric viral infectious diseases. You will support the development and registration of compounds to treat pediatric viral diseases and will be responsible for various aspects of clinical trial program-related activities within the pediatric virology therapeutic area. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study startup/execution/close out, including clinical development input on data analysis and reporting, regulatory submission documents, publications, and scientific presentations.

Essential Functions:

• Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
• Contributes to, or otherwise leads, the design and development of protocols, and Clinical Development components of study manuals, Investigator meeting presentations, CRFs, and Statistical Analysis Plans
• Provides ongoing clinical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and review of safety data
• Addresses questions regarding scientific and related procedural issues from Investigators and sites
• Contributes to, or otherwise leads, clinical development input in the review of data listings, summary tables, study results, and scientific presentations
• Presents scientific information at clinical study investigator meetings
• Manages the clinical development component(s) in the preparation/review of regulatory documents including pediatric development plans, investigator brochures, and (s)NDAs/MAAs/T2Vs
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs

Knowledge, Experience & Skills:

• MD or equivalent medical degree, PharmD, or PhD within a clinical and/or scientific profession, or an equivalent level of professional, clinical and/or scientific education, training and experience
• Experience in pediatric medicine and/or pediatric drug development is highly desirable
• Familiarity with virology, including HIV, viral hepatitis, COVID-19, or related virologic infectious diseases, preferred
• Pharmaceutical/Biotech industry experience in clinical development preferred
• Significant experience working on cross-functional project/program teams in life sciences, healthcare, consulting, or academia
• Excellent verbal and written communication skills and interpersonal skills
• Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership
• Proven analytical abilities as demonstrated through past experience and/or academic research
• Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials
• When needed, ability to travel