Director, Clinical Operations - Late Phase
Director, Clinical Operations - Late Phase
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. Gileads 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 companys five core values. Thats 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
Director, Clinical Operations - Late Phase
We are seeking a talented, experienced, and highly motivated candidate to lead the Late Phase Clinical Operations team in the management of clinical post-authorization programs across Gilead's therapeutic areas. 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 Global Late Phase Leadership Team responsible for the effective delivery of Late Phase accountabilities and will report to the Executive Director of Clinical Operations- Late Phase.
Specific Responsibilities and Skills for Position:
- Demonstrated ability to manage and experience of Post-Authorisation (PAS) Non-Interventional studies and clinical trials including PASS/PMR globally
- Collaboration with colleagues in Clinical Operations, Medical Affairs, Pharmacovigilance & Epidemiology, Project Management, Regulatory, Biometrics and Clinical Research globally ensuring delivery of assigned studies
- Ensures the successful management of activities across multiple therapy areas through teams and the appropriate use of internal and external resources (ARO/CRO)
- Experience of Investigator Sponsored Research (ISR) including Fair Market Value and feasibility assessment, contract negotiation support, tracking and publication follow-up
- May support/oversee Compassionate Use programs
- Member of Global Late Phase Leadership Team responsible for the effective delivery of Late Phase 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
- Proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers
- Contribute to the development of protocols Clinical Study Reports, INDs, NDAs and other clinical/regulatory/safety documents
- May contribute to development of abstracts, presentations and manuscripts
- May contribute to project team governance documents
- 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
- Must be able to solve complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines
- Experience with delivering presentations before executive staff is required
- Directs development of procedural documents within department and cross-functionally
- Excellent verbal, written, interpersonal skills and ability to lead multifunctional teams manage staff and mentor junior staff is required
- Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical studies is required
- Travels nationally and internationally as required
- 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
- Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of non-interventional studies and clinical trials is required
- Thorough knowledge and understanding of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GxPs governing the conduct of clinical trials and non-interventional studies
- Knowledge and understanding of relevant regulations governing compassionate use/expanded access
- Proven ability for successful study implementation and completion
- Demonstrated leadership to motivate teams and drive performance
Experience and Skills:
- At least 12+ years of experience and a BS/BA or higher degree in a relevant scientific discipline
- At least 12+ years of experience and an RN (2 or 3 year certificate)
- 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)
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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 firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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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