Clinical Program Manager, Clinical Operations - Early Development
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases
Clinical Program Manager, Clinical Operations- Early Development
We are seeking a talented, experienced, and highly motivated candidate to join the Early Development Clinical Operations team. The candidate must have the ability to work independently, be an effective leader, and an engaged team member in a dynamic, fast-paced environment.
Specific Responsibilities and Skills for Position:
- Must meet all requirements for Sr. Clinical Trials Manager (Sr. CTM), Clinical Operations position and have demonstrated proficiency in all relevant areas
- Oversees successful implementation of Gilead (GS), Collaborative (CO), Investigator Sponsored Research (ISR) program, expanded access programs, and compassionate use programs
- For GS studies, ability to write study protocols, study reports, and regulatory documents (e.g. IND, NDA, PRAC etc.) with little supervision
- Contributes to development of abstracts, presentations, and manuscripts
- For GS, CO, and ISR studies, must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials
- Provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
- Experience in managing staff as well as mentoring and developing junior staff is required
-Partners with cross functional teams to manage, adjust, and revise project timelines/budgets as necessary
- Communicates project status and issues and ensure project team goals are met
- May represent the company at professional events
- May represent the department at cross-departmental events
- Experience in developing RFPs and selection and management of CROs/vendors
- Functional expertise to initiate, author, or contribute to SOP development, implementation and training
- Recruits, hires, mentors and manages CPA/CTMA/Sr. CTMA/CTM/Sr. CTM direct reports and supports their professional development
- Anticipates moderately complex obstacles and client difficulties and implements solutions to achieve project goals
- Must be able to resolve problems using national and international regulations, guidelines and investigator interaction
- Collaborates with local medical affairs colleagues on country specific studies and initiatives
- Provides knowledge and expertise on country specific regulations, site experience, and suitability for development studies
- Independently manages all components of complex studies, compassionate use programs and non-interventional studies
- Excellent interpersonal skills and demonstrated ability to lead is required
- May design and use all available vehicles for scientific communication within company. With limited supervision may participate in or lead departmental strategic initiatives
- Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision
- Ability to examine functional issues from a broader organizational perspective
- Strong communication and influence skills and ability to create a clear sense of direction is necessary
- Thorough knowledge and understanding of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCPs governing the conduct of clinical trials and non-interventional studies
Experience and Skills:
- At least 8+ years of experience and a BS or BA in a relevant scientific discipline
- At least 8+ years of experience and an RN (2 or 3 year certificate)
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