Director, Clinical Development

Responsibilities may include clinical study design; protocol preparation; support for successful study start-up, maintenance, or close out; conduct or oversight of data cleaning to ensure high quality analyses; conduct or oversight of medical monitoring; contributions to data analysis plans and clinical study report drafting; providing clinical development input into regulatory documents or health authority interactions; leading efforts on publications and scientific communication of study results; thought leader engagement and representing Gilead among external stakeholders; providing clinical and scientific leadership on cross-functional teams.

Stage of studies to which you may be assigned include Phase 2, Phase 3, and Phase 4, with potential for earlier phase work as well. This is an opportunity for exposure and leadership across a range of clinical development activities.

Example Responsibilities

• Provide or oversee medical monitoring for clinical trials
• Provide input into, or lead, clinical trial protocol strategy, design, and content
• Support successful study start-up, maintenance, and/or closeout
• Present at clinical study investigator meetings and represent Gilead in interactions with investigators in other settings
• Serve as clinical reviewer of data listings for data cleaning, ensuring accurate and complete data to support high-quality analyses
• Collaboration with Biostats on analysis planning and generation of study results
• Provide input into, or lead, clinical study report content and responses to health authority inquiries
• Provide input into the Target Product Profile and support, or lead, creation of the Clinical Development Plan for assigned molecules/products
• Provide scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines
• Lead the clinical development component(s) in the preparation/review of investigator brochures or other regulatory documents
• Lead scientific communication of data through scientific conference abstract submissions and through manuscripts
• Adhere to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs

Basic Qualifications

PhD/PharmD and 8 years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment OR MD (or equivalent medical degree) and 4 years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment

Preferred Qualifications

• Experience in the biopharma industry is preferred, with clinical experience in medical monitoring and familiarity addressing medical concerns seen in clinical trials
• Significant experience 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/or presentations
• Medical expertise or experience working in liver disease specifically or internal medicine fields more broadly, with willingness to learn new therapeutic areas
• Demonstrated excellence in complex project management and effectively managing multiple project deliverables and priorities through matrix management and leadership
• Strong scientific acumen and analytical abilities as demonstrated through past industry experience and/or academic research
• Understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials
• Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees
• Strong desire to develop new expertise and learn new in new areas as needed to accomplish team goals and advance professional development within the biopharma industry
• Capable of working with attention to detail in a fast-paced environment
• Commitment to collaboration and teamwork
• When needed, ability to travel

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 the 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