Clinical Program Manager, Early Phase Virology

Scorpion Therapeutics; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Gilead is seeking an experienced Clinical Operations leader to oversee the worldwide execution of Phase I–IV trials across therapeutic areas. The role emphasizes delivering high-quality data in compliance with SOPs, policy, and regulatory guidelines.

You will manage multi-study programs, optimize resources in a fluid environment, and drive process improvements while potentially leading a team of direct reports. Strong regulatory knowledge and vendor oversight are essential.

Qualifications

• Leadership experience in life sciences programs or studies.
• Strong cross-functional collaboration and stakeholder management.
• Experience with regulatory documentation and GxP knowledge.

Responsibilities

• Lead successful execution of studies within budgets and timelines.
• Manage cross-functional Study Management Teams (SMTs) and resource plans.
• Communicate status/issues; ensure complete study documentation.
• Select/manage CROs/vendors (RFPs); assess and mitigate risks.
• Ensure regulatory compliance and author SOPs across programs.

Skills

Leadership

Cross-functional collaboration

Regulatory knowledge

Vendor management

Communication

Education

BA/BS or RN

MA/MS/PharmD/PhD

Job description

Clinical Operations is responsible for the worldwide execution of Phase I-IV clinical trials across Gilead therapeutic areas, ensuring trials are conducted in accordance with applicable SOPs, company policies, and regulatory guidelines to provide timely, high-quality clinical data.

Responsibilities

• Oversee successful execution of studies/multiple studies within a program or multiple programs, including financial responsibility.
• Manage study resources (assess ongoing resource needs and deploy optimally to support a fluid “One Ops” workforce).
• Participate in Clinical Operations and/or cross-functional organizational change initiatives; may act as business process owner (BPO) and/or subject matter expert.
• Encourage innovation by championing new ideas, incorporating best practices, external benchmarking, and standardization.
• People Leader Path (if assigned): manage a team of direct reports.

Example Responsibilities

• Provide ongoing financial oversight; guide/oversee trials within budgets and timelines.
• Lead cross-functional Study Management Teams (SMTs); manage, adjust, and revise timelines/budgets.
• Communicate status/issues; ensure documentation (including study protocols).
• Select/manage oversight of CROs/vendors (including RFPs); assess and mitigate risks.
• Ensure compliance with regulations; initiate/author SOPs as assigned.

Requirements

• BA/BS/RN with 8+ years relevant experience in life sciences, or MA/MS/PharmD/PhD with 6+ years.
• 4+ years cross-functional study management or related leadership; managing study/project teams.
• RFP development and CRO/vendor oversight experience.
• Ability to start-up, manage, and close-out clinical studies; author clinical study/regulatory documentation and SOPs.
• Advanced knowledge of therapeutic areas; full-cycle study management.
• Knowledge of FDA, EMA, ICH, and GCP; authoring documentation experience.
• Strong communication/organization, interpersonal skills, and ability in a matrixed environment; travel as required.

People Leader Accountabilities (if applicable): Create Inclusion; Develop Talent; Empower Teams.