Director, Clinical Development

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were looking for the next wave of passionate and ambitious people ready to make a direct impact.

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Job Description

Director Clinical Development

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 subjectmatter 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 startup execution and closeout 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 crossfunctional teams to support timely and highquality 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 handson pediatric development experience strongly preferred

• Familiarity with virology including HIV viral hepatitis COVID19 or related viral infectious diseases is preferred

• Pharmaceutical or biotechnology industry experience in clinical development is preferred

• Demonstrated experience working on crossfunctional 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 problemsolving 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

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.