Gilead Sciences, Inc. is seeking a Senior Clinical Trials Manager to lead the successful management of all aspects of international clinical trials within designated program budgets and timelines. You will provide guidance, oversight, and contribute to clinical operations strategies.
What You'll Do
- Provide daily oversight and guidance for international clinical trials, ensuring they stay within designated budgets and timelines.
- Coach members of the work team and ensure adherence to established guidelines and processes.
- Anticipate obstacles and implement solutions to achieve project goals.
- Communicate with functional peers and management on project status, departmental issues, and clinical operations strategies.
- Contribute to the development of abstracts, presentations, and manuscripts.
- Participate in the recruiting, hiring, and professional development of Clinical Program Associates (CPAs) and Clinical Research Associates (CRAs).
- Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.
- Write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g., IND, NDA) with little supervision.
- Initiate, author, or contribute to SOP development, implementation, and training.
- Travel is required.
What We're Looking For
- 8+ years of clinical trial experience and a BS or BA in a relevant scientific discipline OR 8+ years of experience and an RN (2 or 3 year certificate).
- Excellent interpersonal skills and demonstrated leadership ability.
- Proven ability to resolve problems using national and international regulations, guidelines, and investigator interaction.
- Strong communication and influence skills, with the ability to create a clear sense of direction.
- Demonstrated ability to successfully develop, implement, manage, and complete clinical trials.
- Thorough knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing clinical trials.
- Experience in developing RFPs and selecting and managing CROs/vendors.
Nice to Have
- Ability to examine functional issues from a broader organizational perspective.
Team & Environment
You will partner with Clinical Program Managers (CPMs), work with management on departmental issues, and coach team members. Our environment respects individual differences and recognizes each employee as an integral member of our company.
Benefits & Compensation
- Compensation range: $143,225.00 - $185,350.00
- Company-sponsored medical, dental, vision, and life insurance plans.
- Paid time off.
- Discretionary annual bonus.
- Discretionary stock-based long-term incentives.
Kite Pharma, a Gilead company, is committed to providing equal employment opportunities to all employees and applicants for employment.
