Clinical Program Manager, Medical Affairs Research Operations
Gilead Sciences
full-time
Posted on:
Location Type: Hybrid
Location: Foster City • California • United States
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Salary
💰 $182,070 - $235,620 per year
About the role
- Provide oversight of IIR & CO portfolio for one or more therapeutic areas.
- May also serve as Global Therapeutic Area Liaison (TAL) for one or more therapeutic areas.
- Understand Medical Affairs structure and liaises regularly with stakeholders.
- Understand Clin Ops global structure, procedures and geographic differences (TA vs geography, differences in publication handling, EU/AUS working cross TAs).
- Represents Medical Affairs Research Operations at governance meetings.
- Critically evaluates scientific proposal or protocol to identify logistical, regulatory and safety implications; highlights potential risks (and proposed mitigations if applicable) to appropriate governance committee.
- Maintains overview of ongoing and planned studies, ensures appropriate resourcing needs, acts as escalation point for study managers for issue resolution.
- Understands rationale for financial variance in Therapeutic Area (TA) and acts as a medical Affairs Research Operations point of contact with Finance team.
- Collaborates and liaises with Medical Affairs Research leadership team to discuss potential process updates as well as simplifications & standardizations to existing processes.
- Provide leadership and support to Study Managers on Investigator Initiated Research (IIR) and Collaborative (CO) Studies including but not limited to: Fair Market Value and feasibility assessment, protocol review, drug forecasting and supply, contract milestone advice, tracking and publication follow-up.
- Provide support to Study Managers with issue escalation/resolution as well as resource planning.
- Establish strong partnerships with external investigators and collaborators; and internal stakeholders (e.g. Med Affairs, Reg Affairs, Development Business Ops, PVE, Clinical Supply Management); to ensure timely, efficient and high-quality study management.
- Identify any “best practice “opportunities to share across Therapeutics Areas and Gilead sites.
- Good understanding of industry standards for CO and IIR studies and keeps abreast of any new changes and developments which could impact Medical Affairs Research.
- Must be able to lead departmental or interdepartmental strategic initiatives.
- Provide training to colleagues on process changes/improvements as necessary.
- Experience in managing staff as well as mentoring and developing junior staff is required.
- May contribute to company sponsored Non-Interventional Studies (i.e. retrospective / prospective observational studies, patient registries, HCP / patient surveys).
- Occasional travel may be required.
Requirements
- Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience OR PhD / PharmD
- At least 8+ years of experience and a RN (2 or 3 year certificate) or BS/BA in a relevant scientific discipline.
- At least 6+ years of experience and a Masters' degree or higher; scientific discipline preferred.
- Experience in the review and oversight of Investigator Sponsored & Collaborative Research strongly preferred.
- Experience in Phase IV and non-interventional studies preferred.
- Prior Global or large affiliate experience in medical affairs activities preferred
- Prior supervisory/leadership experience preferred.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives (eligibility may vary based on role)
- paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
investigator initiated researchcollaborative studiesprotocol reviewdrug forecastingfinancial variance analysisissue resolutionresource planningstudy managementnon-interventional studiesclinical operations
Soft Skills
leadershipmentoringcollaborationcommunicationproblem-solvingstrategic initiative managementtrainingstakeholder engagementprocess improvementpartnership building
Certifications
Bachelor's DegreeMaster's DegreePhDPharmDRN certificate