Executive Director, Clinical Development (Pediatrics)
Scorpion Therapeutics, San Francisco, California, United States, 94199
Role Summary
This position is 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 1–3 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 across your project portfolio. 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, as applicable. You will liaise with the Gilead Asset Teams and support the Pediatric Development Leads as they liaise with the Development Evidence Teams. Additional leadership responsibilities include input into regulatory documentation, publications, and scientific presentations. This role helps ensure medicines are studied in and approved for pediatric populations. Location: Foster City, CA, with remote options for highly qualified candidates. 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 for Clinical Development and cross-functional areas Liaise and engage between the pediatric teams and the Gilead Asset Teams and support the Pediatric Development Leads in engaging with the Development Evidence Teams Leadership role in clinical strategy and execution of all pediatric virology programs including collaboration with Vice Presidents in Virology (Department Review Committee Chairs) and Development Evidence Leaders for molecules / products Represents or oversee representation for the assigned molecules / products in cross-functional steering and /or governance committees Manages direct reports as Pediatric Development Team Leaders to ensure clinical development project deliverables and timelines are consistently met Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules / products In general, provides oversight for communications, both written and oral, with health authorities Oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents including pediatric investigation plans (PIPs) and pediatric study plans (PSPs) Oversees and directs as needed the collection and assimilation of ongoing data for internal analysis and review and the preparation and/or review of data listings, summary tables, study results and scientific presentations Presents or oversees presentations of scientific information at scientific conferences as well as clinical study investigator meetings; where applicable, takes a lead on authoring scientific publications Key insight and involvement in the evaluation of pediatric aspects of business development opportunities Develops thought leader and other external relationships that can guide short- and long-range pediatric clinical development strategies and direction for multiple molecules, the disease or therapeutic area overall Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs Provides scientific and clinical guidance to Research, Biology, Virology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff, as applicable May lead two or more specific components of organizational strategic initiatives Qualifications
Required: 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 Preferred: Experience in pediatric drug development is strongly preferred; experience performing clinical research studies in HIV treatment or prevention, viral hepatitis, respiratory or other viral diseases is also an asset Required: Extensive experience leading high-complexity cross-functional drug development strategies and plans, including short- and long-range strategic planning, governance, and oversight Required: Extensive experience taking the lead on clinical study plans, protocol design, regulatory filings, clinical publications, and presentations Required: Understanding of Clinical Pharmacology/Clinical Pharmacokinetics principles and familiarity with using modeling and simulation to support pediatric drug development Required: Line management (direct reports) experience of at least 5+ years in drug development in the biopharma industry Preferred: Extensive experience interacting with and presenting to executives is strongly preferred Has an expert-level knowledge of drug development, as evidenced by proven track record in setting short- and long-range drug development strategies and plans Leadership experience with cross-functional organizations and strong EQ Has thorough understanding of pharmaceutical regulatory requirements for pediatric drug development globally and impact on development and execution of clinical trials Strong leadership skills with an ability to set vision, lead change, and mentor others Ability to work effectively in a multidisciplinary, cross-functional team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution Demonstrated ability to lead by influence and align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives When needed, ability to travel 8–12 times a year both domestically and internationally
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This position is 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 1–3 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 across your project portfolio. 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, as applicable. You will liaise with the Gilead Asset Teams and support the Pediatric Development Leads as they liaise with the Development Evidence Teams. Additional leadership responsibilities include input into regulatory documentation, publications, and scientific presentations. This role helps ensure medicines are studied in and approved for pediatric populations. Location: Foster City, CA, with remote options for highly qualified candidates. 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 for Clinical Development and cross-functional areas Liaise and engage between the pediatric teams and the Gilead Asset Teams and support the Pediatric Development Leads in engaging with the Development Evidence Teams Leadership role in clinical strategy and execution of all pediatric virology programs including collaboration with Vice Presidents in Virology (Department Review Committee Chairs) and Development Evidence Leaders for molecules / products Represents or oversee representation for the assigned molecules / products in cross-functional steering and /or governance committees Manages direct reports as Pediatric Development Team Leaders to ensure clinical development project deliverables and timelines are consistently met Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules / products In general, provides oversight for communications, both written and oral, with health authorities Oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents including pediatric investigation plans (PIPs) and pediatric study plans (PSPs) Oversees and directs as needed the collection and assimilation of ongoing data for internal analysis and review and the preparation and/or review of data listings, summary tables, study results and scientific presentations Presents or oversees presentations of scientific information at scientific conferences as well as clinical study investigator meetings; where applicable, takes a lead on authoring scientific publications Key insight and involvement in the evaluation of pediatric aspects of business development opportunities Develops thought leader and other external relationships that can guide short- and long-range pediatric clinical development strategies and direction for multiple molecules, the disease or therapeutic area overall Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs Provides scientific and clinical guidance to Research, Biology, Virology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff, as applicable May lead two or more specific components of organizational strategic initiatives Qualifications
Required: 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 Preferred: Experience in pediatric drug development is strongly preferred; experience performing clinical research studies in HIV treatment or prevention, viral hepatitis, respiratory or other viral diseases is also an asset Required: Extensive experience leading high-complexity cross-functional drug development strategies and plans, including short- and long-range strategic planning, governance, and oversight Required: Extensive experience taking the lead on clinical study plans, protocol design, regulatory filings, clinical publications, and presentations Required: Understanding of Clinical Pharmacology/Clinical Pharmacokinetics principles and familiarity with using modeling and simulation to support pediatric drug development Required: Line management (direct reports) experience of at least 5+ years in drug development in the biopharma industry Preferred: Extensive experience interacting with and presenting to executives is strongly preferred Has an expert-level knowledge of drug development, as evidenced by proven track record in setting short- and long-range drug development strategies and plans Leadership experience with cross-functional organizations and strong EQ Has thorough understanding of pharmaceutical regulatory requirements for pediatric drug development globally and impact on development and execution of clinical trials Strong leadership skills with an ability to set vision, lead change, and mentor others Ability to work effectively in a multidisciplinary, cross-functional team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution Demonstrated ability to lead by influence and align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives When needed, ability to travel 8–12 times a year both domestically and internationally
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