Executive Director, Clinical Development (Pediatrics)
Gilead Sciences, Inc., Foster City, California, United States, 94420
Executive Director, Clinical Development (Pediatrics)
Location: Foster City, CA (global headquarters); we will also consider highly qualified remote employees. Job Description
This is an opportunity to work in a dynamic role to support the clinical development of novel drugs for viral infectious diseases in children. The Executive Director, Clinical Development will provide expertise in pediatric drug development and oversee the design, conduct, and evaluation of Phase 1, 2, and 3 clinical trials. You will lead a portfolio of pediatric programs in virology clinical development for HIV treatment and PrEP, viral hepatitis, viral respiratory diseases, and other antiviral indications. You will supervise Pediatric Development Leads across the assigned project portfolio and be accountable for the design, conduct, evaluation, close-out and reporting of clinical trials. You will lead or oversee the development, implementation, and execution of the pediatric clinical development strategy for the assigned molecules/products, including Pediatric Clinical Development Plans and input into Target Product Profiles where applicable. You will liaise with the Gilead Asset Teams and support the Pediatric Development Leads as they liaise with the Development Evidence Teams, and contribute to regulatory documentation, publications, and scientific presentations. We are committed to ensuring medicines are studied in and approved for pediatric populations. Key Responsibilities
Strategic input and oversight for pediatric development programs
Oversee development and execution of Phase 1, 2, and 3 clinical trials and provide scientific expertise
Serve as a resource for pediatric drug development across Clinical Development and cross-functional areas
Liaise between pediatric teams and Gilead Asset Teams; support Pediatric Development Leads in engaging with Development Evidence Teams
EXAMPLE RESPONSIBILITIES: Leadership in clinical strategy and execution of all pediatric virology programs; collaborate with Virology leadership and Development Evidence Leaders
Represent or oversee representation for assigned molecules/products in cross-functional steering and governance committees
Manage direct reports as Pediatric Development Team Leaders to ensure project deliverables and timelines are met
Lead or oversee clinical trial protocol design and study reporting for assigned molecules/products
Oversee communications with health authorities
Oversee medical monitoring of trials, including eligibility, toxicity management, and drug safety surveillance
Lead regulatory document preparation (PIPs/PSPs) and data collection for analysis and reporting
Prepare and present data listings, summary tables, and study results; contribute to scientific publications
Develop external relationships to guide pediatric development strategies
Ensure adherence to Good Clinical Practice and Gilead SOPs
Provide scientific guidance to cross-functional teams
May lead components of organizational strategic initiatives
We require candidates to review the qualifications carefully and apply accordingly. MINIMUM EDUCATION & EXPERIENCE
MD or equivalent with 8+ years’ experience OR MS, PharmD or PhD in clinical research or clinical pharmacology with 14+ years’ experience in drug development in the biopharma industry
Experience in pediatric drug development is strongly preferred; experience in HIV treatment or prevention, viral hepatitis, respiratory or other viral diseases is an asset
Extensive experience leading high-complexity cross-functional drug development strategies and plans, including governance and oversight
Extensive experience leading clinical study plans, protocol design, regulatory filings, publications, and presentations
Understanding of Clinical Pharmacology/Clinical Pharmacokinetics and modeling/simulation for pediatric development
Line management experience of at least 5+ years in biopharma drug development
Experience presenting to executives is strongly preferred
KNOWLEDGE & OTHER REQUIREMENTS
Expert-level knowledge of drug development with a track record of setting development strategies
Leadership experience with cross-functional teams and strong EQ
Understanding regulatory requirements for pediatric development globally
Strong leadership, vision, and mentoring abilities
Ability to work in a multidisciplinary, inclusive, cross-functional environment
Strong communication and organizational skills; ability to distill complex matters into a clear business case
Ability to travel 8-12 times per year (domestic/international, as needed)
Salary range refers to Bay Area and other US locations and may vary by experience and location. Benefits include medical, dental, vision, life insurance, and a discretionary compensation package. See compensation details on the Gilead careers site. Equal Employment Opportunity
- Gilead Sciences is an equal opportunity employer. We value diversity and inclusion and prohibit discrimination based on race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other prohibited characteristic. Reasonable accommodations are available for applicants during the hiring process. For current employees: please apply via the Internal Career Opportunities portal in Workday. Job Requisition ID R0050170
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Location: Foster City, CA (global headquarters); we will also consider highly qualified remote employees. Job Description
This is an opportunity to work in a dynamic role to support the clinical development of novel drugs for viral infectious diseases in children. The Executive Director, Clinical Development will provide expertise in pediatric drug development and oversee the design, conduct, and evaluation of Phase 1, 2, and 3 clinical trials. You will lead a portfolio of pediatric programs in virology clinical development for HIV treatment and PrEP, viral hepatitis, viral respiratory diseases, and other antiviral indications. You will supervise Pediatric Development Leads across the assigned project portfolio and be accountable for the design, conduct, evaluation, close-out and reporting of clinical trials. You will lead or oversee the development, implementation, and execution of the pediatric clinical development strategy for the assigned molecules/products, including Pediatric Clinical Development Plans and input into Target Product Profiles where applicable. You will liaise with the Gilead Asset Teams and support the Pediatric Development Leads as they liaise with the Development Evidence Teams, and contribute to regulatory documentation, publications, and scientific presentations. We are committed to ensuring medicines are studied in and approved for pediatric populations. Key Responsibilities
Strategic input and oversight for pediatric development programs
Oversee development and execution of Phase 1, 2, and 3 clinical trials and provide scientific expertise
Serve as a resource for pediatric drug development across Clinical Development and cross-functional areas
Liaise between pediatric teams and Gilead Asset Teams; support Pediatric Development Leads in engaging with Development Evidence Teams
EXAMPLE RESPONSIBILITIES: Leadership in clinical strategy and execution of all pediatric virology programs; collaborate with Virology leadership and Development Evidence Leaders
Represent or oversee representation for assigned molecules/products in cross-functional steering and governance committees
Manage direct reports as Pediatric Development Team Leaders to ensure project deliverables and timelines are met
Lead or oversee clinical trial protocol design and study reporting for assigned molecules/products
Oversee communications with health authorities
Oversee medical monitoring of trials, including eligibility, toxicity management, and drug safety surveillance
Lead regulatory document preparation (PIPs/PSPs) and data collection for analysis and reporting
Prepare and present data listings, summary tables, and study results; contribute to scientific publications
Develop external relationships to guide pediatric development strategies
Ensure adherence to Good Clinical Practice and Gilead SOPs
Provide scientific guidance to cross-functional teams
May lead components of organizational strategic initiatives
We require candidates to review the qualifications carefully and apply accordingly. MINIMUM EDUCATION & EXPERIENCE
MD or equivalent with 8+ years’ experience OR MS, PharmD or PhD in clinical research or clinical pharmacology with 14+ years’ experience in drug development in the biopharma industry
Experience in pediatric drug development is strongly preferred; experience in HIV treatment or prevention, viral hepatitis, respiratory or other viral diseases is an asset
Extensive experience leading high-complexity cross-functional drug development strategies and plans, including governance and oversight
Extensive experience leading clinical study plans, protocol design, regulatory filings, publications, and presentations
Understanding of Clinical Pharmacology/Clinical Pharmacokinetics and modeling/simulation for pediatric development
Line management experience of at least 5+ years in biopharma drug development
Experience presenting to executives is strongly preferred
KNOWLEDGE & OTHER REQUIREMENTS
Expert-level knowledge of drug development with a track record of setting development strategies
Leadership experience with cross-functional teams and strong EQ
Understanding regulatory requirements for pediatric development globally
Strong leadership, vision, and mentoring abilities
Ability to work in a multidisciplinary, inclusive, cross-functional environment
Strong communication and organizational skills; ability to distill complex matters into a clear business case
Ability to travel 8-12 times per year (domestic/international, as needed)
Salary range refers to Bay Area and other US locations and may vary by experience and location. Benefits include medical, dental, vision, life insurance, and a discretionary compensation package. See compensation details on the Gilead careers site. Equal Employment Opportunity
- Gilead Sciences is an equal opportunity employer. We value diversity and inclusion and prohibit discrimination based on race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other prohibited characteristic. Reasonable accommodations are available for applicants during the hiring process. For current employees: please apply via the Internal Career Opportunities portal in Workday. Job Requisition ID R0050170
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