Sr. Director
Clinical Development, MD, Oncology, Lung
Posted on 10/29/2022
INACTIVE
Locations
Morristown, NJ, USA • San Carlos, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Communications
Requirements
  • MD or equivalent with 6+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment
  • Board certification in Oncology is preferred, including familiarity with clinical solid tumor and/or hematologic medicine
  • 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 and managing large-scale budgets and other resources is strongly preferred
  • Demonstrated excellence leading large and complex teams in life sciences, healthcare, consulting or academia
  • 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 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. Able to distill complex matters into a clear business case and roadmap for execution
  • When needed, ability to travel
Responsibilities
  • Works closely with cross-functional leaders and teams to develop, implement and oversee the clinical development strategy for the assigned molecules / products
  • Routinely represents the assigned molecules / products in cross-functional steering and /or governance committees
  • May lead the development of the Target Product Profile and Clinical Development Plan for assigned molecules / products
  • May lead the Global Development Team for assigned molecules; providing scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines
  • May act as a core team member on the Program Strategy Team, which is responsible for the full lifecycle management of the assigned products
  • Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules / products
  • In general, serves as the lead for communications, both written and oral, with health authorities
  • Provides or 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, investigator brochures and development plans
  • 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
  • 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 opportunities
  • Develops thought leader and other external relationships that can guide short- and long-range clinical development strategies and direction for assigned molecules /products
  • Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs
  • May also manage one or more direct reports
Gilead Sciences

10,001+ employees

Critical disease biopharmaceutical development
Company Overview
Gilead’s mission is to discover, develop and deliver innovative therapeutics for people with life-threatening diseases. The company is committed to creating a healthier world for everyone through their research, development of forward medicines, and clinical trials.
Benefits
  • Paid family time off and paid parental time off
  • Generous 401(k) contribution matching
  • Comprehensive medical plans that cover both physical and mental healthcare
  • Global Wellbeing Reimbursement
  • Time Off
  • Global Volunteer Day
  • Giving Together Program
  • Employee Support Programs
  • Flexible Work Options
Company Core Values
  • Integrity: Doing What’s Right
  • Inclusion: Encouraging Diversity
  • Teamwork: Working Together
  • Accountability: Taking Personal Responsibility
  • Excellence: Being Your Best