Senior Director, Clinical Research

Senior Director, Clinical Research

Gilead

Dublin, Ireland

Position Overview

You may act as a Clinical Development Lead on pediatric clinical trial programs for assigned molecules/products in Virology. As Clinical Development Lead, you will be accountable for the design, conduct, evaluation, close-out and reporting of clinical trials for the assigned molecules /products. You may take the lead on the development, implementation and execution of the pediatric clinical development strategy for the assigned molecules/products, which will include being the clinical lead for development of Pediatric Study Plans and Pediatric Investigation Plans. Additional responsibilities may include, but are not limited to, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.

Example Responsibilities:

  • Core member of Virology Pediatric Project Team
  • Works closely with cross-functional members of the pediatric team to develop, implement and oversee the pediatric clinical development strategy for the assigned molecules/products
  • Provides scientific and clinical guidance to the pediatric team and colleagues to meet clinical development project deliverables and timelines
  • Contributes to the development of the Target Product Profile and Clinical Development Plan for pediatric development aspects of assigned molecules/products
  • Represents pediatric plans for assigned molecules/products in cross-functional steering and /or governance committees
  • May act as an ad hoc member of the Global Development Team(s) and/or on the Program Strategy Team(s), which is responsible for the full lifecycle management of the assigned products, for issues related to pediatric development; obtains input from GDT and/or PST cross-functional team members on the assigned molecules/products, as appropriate
  • Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for pediatric studies with assigned molecules/products
  • Provides or oversees ongoing clinical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance
  • May directly manage or delegate and oversee 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
  • In general, serves as the Clinical lead for pediatric communications, both written and oral, with health authorities for the assigned molecules/products
  • Leads or otherwise oversees and directs the pediatric clinical development component(s) in the preparation/review of regulatory documents including PIPs and PSPs, investigator brochures and development plans
  • Presents scientific information at scientific conferences as well as clinical study investigator meetings; where applicable, takes a lead on authoring scientific publications
  • May assist in the clinical evaluation of business development and external collaborative opportunities
  • Develops thought leader and other external relationships that can guide short- and long-range pediatric clinical development strategies and direction for assigned molecules /products
  • May manage one or more direct reports
  • Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

  • MD or equivalent with significant clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment
  • MS, PharmD or PhD in clinical research or clinical pharmacology with extensive scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment
  • BS or RN with significant relevant scientific and/or drug development experience
  • Relevant experience in pediatric medicine and/or pediatric drug development is preferred
  • Experience in the biopharma industry is strongly preferred
  • Multiple years’ experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting or academia
  • Extensive experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations
  • Multiple years’ line management (direct reports) experience is preferred
  • Experience interacting with and presenting to executives is strongly preferred
  • Experience managing large-scale budgets and other resources
  • Demonstrated excellence leading large and complex teams in life sciences

Knowledge & Other Requirements

  • Has an expert-level of knowledge of drug development, as evidenced by proven track record in setting short- and long-range drug development strategies and plans
  • Has thorough understanding of pharmaceutical regulatory requirements, ideally including pediatric 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; able to distill complex matters into a clear business case and roadmap for execution
  • When needed, ability to travel

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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