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Sr. Director
Clinical Development, MD, Early Development Oncology
Confirmed live in the last 24 hours
Locations
San Carlos, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Leadership
Management
Research
Requirements
  • Will be part of a team responsible for all scientific aspects of conceptualizing and planning trials
  • Will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans
  • Provides or oversees medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance
  • Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice
  • Coordinates the collection and analysis of clinical data for internal analysis and review
  • Will be part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections
  • Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings
  • Develops manuscripts for publication in peer-reviewed journals
  • Will be part of a team responsible for defending the clinical development program before regulatory authorities
  • Serves as a scientific and clinical resource within Gilead Clinical Research
  • Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff
  • Assists in the clinical evaluation of business development opportunities
  • MD degree and board certification or equivalent years of clinical research experience in Oncology
  • Two (2) + years required in the pharmaceutical industry with a proven success record in clinical research studies and trial design
  • Executive Medical Director Level to be considered with 6+ years of drug development experience either within biopharma industry, academic/research organizations early through late stage development, including the design and conduct of clinical studies
  • Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices
  • Ability to think analytically and strategically to formulate, develop, and execute clinical plans
  • Strong leadership skills with an ability to set vision, lead change, and mentor others
  • Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving
  • Excellent scientific written and oral communication skills
  • Facility with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results
  • Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality
  • Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20-30% travel expected)
Responsibilities
  • The clinical research physician will play a key role at all stages of development for product programs from the drug discovery stage through product registrations world-wide
  • The successful candidate will have oversight for ongoing and planned product trials within the Oncology therapeutic area
  • The Clinical Research MD will report to a more senior member of the Oncology clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities
  • Strategic Thinking: Understands the competitive landscape within Oncology, including having a perspective on how clinical practice and patient needs are evolving as well as therapeutic area trends and their relevance to the Gilead portfolio; Responsible for clinical development's assessment of both internal and external opportunities to advance Gilead's portfolio and actively seeks opportunities to form external partnerships to strengthen Gilead's Oncology portfolio and probability of success
  • Delivery Excellence: Responsible for ensuring that key Oncology program is aligned with disease area strategies and appropriate activities are prioritized; Facilitates efforts across therapeutic area and is accountable for the technical execution of programs within the Oncology portfolio; Supports the operational direction for programs clinical research teams within the Oncology organization, which includes responsibility for scientific and medical aspects of clinical studies such as protocol design, risk benefit assessment, and medical monitoring
  • Integrity (Doing What's Right)
  • Inclusion (Encouraging Diversity)
  • Teamwork (Working Together)
  • Excellence (Being Your Best)
  • Accountability (Taking Personal Responsibility)
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