Director, Clinical Development (MD)

Key Responsibilities

• Provides scientific and clinical expertise to cross-functional teams to support clinical development project deliverables and timelines, including but not limited to Respiratory/Emerging Viruses as well as pandemic preparedness and/or emerging outbreak responses.
• Contributes to the development and review of clinical trial protocols, clinical study reports, and responses to health authority inquiries.
• Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Contributes to the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures, and development plans.
• Supports the collection, review, and interpretation of clinical data for internal analysis and decision-making.
• Manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
• Presents scientific and clinical information at investigator meetings, internal forums, and scientific conferences.
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.

Basic Qualifications

MD and Four Years' Experience

Preferred Qualifications

• Clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment; Experience in the biopharma industry is preferred, with clinical experience in medical monitoring.
• Training and/or experience in Infectious Diseases, Immunology, Pulmonology, or a related medical specialty, and familiarity with emerging viruses and/or pandemic preparedness is preferred.
• Significant experience working on, with and leading cross-functional project/program teams in life sciences, healthcare, consulting or academia.
• Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
• Experience presenting scientific or clinical data through publications, abstracts, posters, presentations, or other scholarly activities is preferred.
• Experience collaborating across multidisciplinary teams in academic, clinical, research, or industry settings is preferred.
• Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.
• Demonstrated ability to learn quickly and apply new concepts in a fast-paced environment.
• Demonstrated flexibility and adaptability, with the ability to manage multiple priorities and contribute across projects as needed.
• Strong analytical and critical thinking skills, as evidenced through clinical practice, research, academic training, or other professional experiences.
• Foundational understanding of the drug development process and clinical research, or a strong interest and aptitude for learning these areas.
• Understanding of FDA and EMA regulations, ICH guidelines, GCP, and standard clinical research principles is preferred but not required.
• Strong scientific and medical knowledge, with the ability to critically evaluate and interpret clinical and scientific data.
• Excellent communication, presentation, organizational, and interpersonal skills.
• Ability to work effectively in a collaborative, cross-functional environment.
• Willingness and ability to travel as needed.

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.