Director, Clinical Development

Gilead Sciences•Foster City, CA

1d•$243,100 - $314,600•Hybrid

About The Position

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Requirements

PhD/ Pharm D 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

Nice To Haves

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.

Responsibilities

Support or lead multiple components of clinical trial programs in Inflammation/Fibrosis clinical development, including primary biliary cholangitis (PBC) or other liver disease indications with potential for opportunities across the Inflammation therapeutic area at Gilead.
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.
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.