Clinical Program Manager, Medical Affairs Research Operations

Gilead Sciences•Foster City, CA

10d•Hybrid

About The Position

At Gilead, we are committed to creating a healthier world for all people. For over 35 years, we have been dedicated to tackling diseases such as HIV, viral hepatitis, COVID-19, and cancer, working relentlessly to develop therapies that improve lives and ensure global access. Our mission requires collaboration, determination, and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. We are seeking a talented, experienced, and highly motivated candidate to successfully manage Collaborative (CO) and Investigator Initiated Research (IIR) programs across Gilead’s therapeutic areas. The candidate must have the ability to work independently, be an effective leader, and an engaged team member in a dynamic, fast-paced environment. This role will be a hybrid office-based role (three days in office) in our headquarters in Foster City, CA.

Requirements

Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience OR PhD / PharmD
Comprehensive understanding of FDA/EMA regulations, ICH guidelines, GCP, and clinical operations principles.
Knowledge of global pharmaceutical regulatory requirements and their impact on clinical trials.
Excellent analytical, problem-solving, and organizational skills; ability to multitask and meet deadlines.
Able to work independently and suggest solutions for project issues.

Nice To Haves

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.

Responsibilities

Provide oversight of IIR & CO portfolio for one of more therapeutic areas.
May also serve as Global Therapeutic Area Liaison (TAL) for one or more therapeutic areas.
Understands Medical Affairs structure and liaises regularly with stakeholders.
Understands 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.
Strong interpersonal, communication, leadership, and influence skills.
Comprehensive understanding of FDA/EMA regulations, ICH guidelines, GCP, and clinical operations principles.
Knowledge of global pharmaceutical regulatory requirements and their impact on clinical trials.
Excellent analytical, problem-solving, and organizational skills; ability to multitask and meet deadlines.
Able to work independently and suggest solutions for project issues.
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.