Clinical Program Manager, Medical Affairs Research Operations

Role Overview

• 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