Associate Director, Clinical Operations - Early Phase

Location
Foster City, CA
Posted
Nov 25, 2021
Ref
2666980
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Associate Director, Clinical Operations - Early Phase
United States – RemoteUnited States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible



CLINICAL OPERATIONS: Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products.

The Associate Director will report directly into the Director, Clinical Operations- Early Development. The position is based in Foster City, California or may be located Remotely within the United States.

Specific Responsibilities and Skills for Position:
  • Must meet all requirements for CPM position and have demonstrated proficiency in all relevant areas
  • Provides leadership and therapeutic expertise for the successful management of international clinical trials
  • Contributes to the strategic implementation of a clinical development program(s)
  • Demonstrated ability to manage international clinical trials within designated program budgets and timelines is required
  • Must possess a proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers
  • Extensive experience in developing RFPs, selection of CROs/vendors and management of external resources is required
  • Ability to initiate, participate in and/or lead departmental or interdepartmental strategic initiatives
  • Participates in development of SOPs, Clinical Study Reports, INDs, NDAs and other clinical, regulatory and safety documents
  • Provides input into the management of the Clinical Operations department
  • Effectively solves problems and uses judgment relating to national and international regulations, guidelines, investigator interactions and timelines
  • Recruits, hires, mentors and manages CTM/CPM direct reports and supports their professional development
  • Leads cross-functional study management team and should have good influencing skills with study stakeholders
  • Travels nationally and internationally as required


Knowledge:
  • Excellent interpersonal skills, and demonstrated ability to lead is required
  • Experience in managing staff as well as mentoring and developing junior staff is required
  • Strong communication and influence skills and ability to create a clear sense of direction is necessary
  • Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction
  • Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials
  • Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
  • Experience in developing RFPs and selection and management of CROs/vendors
  • Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision
  • Ability to examine functional issues from a broader organizational perspective.
  • Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision
  • Functional expertise to initiate, author, or contribute to SOP development, implementation, and training


Minimum Qualifications:
  • Bachelor's Degree with 8+ years of clinical operations experience
  • 8+ years of experience and an RN (2 or 3 year certificate)

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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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

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