Clinical Program Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $165.5k - $214.2k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🏥 Clinical Operations

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1987

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Gilead Sciences is a leading biopharmaceutical company that focuses on discovering, developing, and delivering innovative therapeutics for patients with life-threatening diseases. The company is highly recognized for its contributions in virology, particularly HIV and hepatitis, and is actively expanding its therapeutic reach into fields like oncology and inflammation. Gilead has a strong pipeline of medicines, with over 25 products available globally and 50 clinical programs. Known for its commitment to health equity, the company also actively funds HIV research and causes. Gilead's dedication to scientific innovation and health equity aims to tackle the world's most pressing health challenges, improving patient lives globally.

📋 Description

• Oversee worldwide execution of Phase I–IV clinical trials across Gilead therapeutic areas • Ensure clinical trials comply with SOPs, company policies, regulatory guidelines, and quality and timeliness standards • Manage successful execution of studies and multiple studies within programs, including financial responsibility • Assess and deploy study resources to support the One Ops workforce • Provide ongoing financial oversight of assigned clinical trials and programs • Provide input into therapeutic-area and functional-area strategic and operational plans • Guide and oversee clinical trial management within program budgets and timelines • Lead cross-functional Study Management Teams and influence stakeholders • Manage and revise project timelines and budgets with cross-functional teams • Communicate project status and issues, escalate issues, and ensure team goals are met • Contribute to study documentation, including protocols • Select, manage, and oversee CROs and vendors, including RFP development • Identify obstacles and implement solutions, risk assessments, and mitigation strategies • Resolve issues under national and international regulations and guidelines • Track, oversee, and communicate program status using available tools • Lead or participate in departmental and interdepartmental strategic initiatives • Develop, implement, and train on SOPs • Ensure affiliate Clinical Operations activities meet local regulations and usual practice • Ensure team work complies with established practices, policies, processes, and regulatory requirements • Hire, develop, and retain diverse talent; set expectations and coach direct reports on performance and career development

🎯 Requirements

• BA / BS / RN with 8 or more years’ relevant clinical or related experience in life sciences, or MA / MS / PharmD / PhD with 6 or more years’ relevant clinical or related experience in life sciences • Minimum of 4 years’ cross-functional study management or related leadership experience in life sciences • Multiple years’ experience managing study or project teams • Advanced knowledge of one or more disease or therapeutic areas • Experience developing RFPs and selecting, overseeing, and managing CROs or other vendors • Ability to start up, manage, and close out clinical studies • Experience authoring clinical study and regulatory documentation and SOPs • Complete knowledge of full-cycle study management • Advanced knowledge of study management best practices and tools • Thorough knowledge of FDA, EMA, national regulations, ICH guidelines, and GCP • Ability to lead and influence programs, projects, and initiatives • Strong interpersonal, communication, and organizational skills • Ability to work successfully in a team-oriented, highly matrixed environment • Effectiveness coaching, guiding, directing, and managing the performance of others • Effectiveness proactively managing change • Ability to travel as required

🏖️ Benefits

• Discretionary annual bonus • Discretionary stock-based long-term incentives • Paid time off • Company-sponsored medical insurance • Company-sponsored dental insurance • Company-sponsored vision insurance • Company-sponsored life insurance

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