Director, Clinical Operations - Inflammation

Location
Foster City, CA, United States
Posted
May 26, 2021
Ref
2278019
Required Education
Bachelors Degree
Position Type
Full time
Director, Clinical Operations - Inflammation
United 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

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

Director, Clinical Operations - Inflammation

We are seeking a talented, experienced, and highly motivated candidate to lead a team within the Inflammation Clinical Operations (CO) department in the management of PhIb - III studies, and to be the CO project team representative for certain compounds/ indications. The candidate must have the ability to work independently, be an effective leader, and an engaged team member in a dynamic, fast-paced environment.

This position is a member of the Inflammation Leadership Team responsible for the effective delivery of Clinical Operations accountabilities and will report to the TA Head, Inflammation CO.


Specific Responsibilities and Skills for Position:
  • Proven ability and experience of multiple PhIb-III clinical trials globally within designated program budgets and timelines is required, to enable translation to appropriate oversight at this level
  • Collaboration with cross functional colleagues globally (Clinical Research, Project Management, PVE, Regulatory, Biometrics, Clinical Pharmacology, CSM, Medical Affairs, etc) to ensure timely delivery of assigned studies and strategic input into applicable project team forums
  • Member of the Inflammation Leadership Team responsible for the effective delivery of accountabilities
  • Manages people managers and/or study teams to ensure optimal deployment of resources
  • Recruit, hire, mentor, and manage direct reports as required and support their professional development
  • Ability to initiate and lead departmental or interdepartmental strategic initiatives
  • Extensive experience in developing RFPs, selection of CROs/vendors and management of external resources is required
  • Contributes to Clinical Study Reports, INDs, NDAs and other clinical/regulatory/safety documents
  • May contribute to project team governance documents
  • May contribute to development of abstracts, presentations and manuscripts
  • Represents the company at professional events and may present company clinical initiatives and findings at such events
  • Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams
  • Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problems
  • Experience with delivering presentations before executive staff is required
  • Directs development of procedural documents within department and cross-functionally
  • Travels nationally and internationally as required


Knowledge:
  • Excellent verbal, written, interpersonal skills, and ability to lead multifunctional teams, ability to manage staff and mentor junior staff is required
  • Demonstrated excellence in complex project management and effectively managing multiple projects/priorities is required
  • Thorough knowledge and understanding of FDA and EMA Regulations (or relevant local regulations), ICH Guidelines, and GxPs governing the conduct of clinical trials
  • Demonstated leadership to motivate teams and drive performance


Experience and Skills:
  • At least 12+ years of experience and a RN (2 or 3 year certificate), BS/BA, or higher degree in a relevant scientific discipline
  • At least 10+ years of experience and a Masters' degree or higher; scientific discipline preferred


Behaviors:
  • Curious with a strong learning agility (the ability to rapidly study, analyse and understand new situations and business problems)
  • Operationally excellent and resilient in the context of a rapidly changing environment
  • Organised with systematic approach to prioritization
  • Exhibit Gilead's leadership commitments: To Be Bold (in aspiration and agile in execution), To Care (and make time for people), To Listen (speak openly and explain the 'why'), To Own (the impact of your words and actions) and To Trust (others and yourself to make sound decisions).


Gilead Core Values:
  • Integrity (always doing the right thing),
  • Teamwork (collaborating in good faith)
  • Excellence (working at a high level of commitment and capability)
  • Accountability (taking personal responsibility)
  • Inclusion (encouraging diversity)
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
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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:
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