Clinical Program Manager- Early Phase

Gilead Sciences, Inc. Foster City , CA 94404

Posted 1 week ago

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

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

Knowledge:

  • 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 7+ years of experience and a BS or BA in a relevant scientific discipline

  • At least 7+ years of experience and an RN (2 or 3 year certificate)

#LI-MG1

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.


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Clinical Program Manager- Early Phase

Gilead Sciences, Inc.