Associate Director, Clinical Operations - Late Phase
Associate 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
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.
Associate Director, Clinical Operations- Late Phase
We are seeking a talented, experienced, and highly motivated candidate to succesfully manage Gilead Sponsored Non-Interventional studies, 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.
Specific Responsibilities and Skills for Position:
- Must meet all requirements for CPM position and have demonstrated proficiency in all relevant areas.
- Demonstrated ability to manage international clinical trials within designated program budgets and timelines is required. Experience managing Non-Interventional studies (e.g. Post Authorisation Safety studies, Patient Registries, HCP Survey, Real World Evidence, Prospective and Retrospective data collection studies) preferred.
- Provides leadership, expertise and strategic direction for the successful management of Gilead Sponsored Non-Interventional studies, across different therapeutic areas.
- Provides leadership and support for effective management of Investigator Sponsored and Collaborative Research, across different therapeutic areas.
- May support/oversee Compassionate Use programs.
- 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
- Participate as an active member of the Global Clinical Operations Late Phase extended Leadership team and other team meetings.
- Effectively solves problems and uses judgment relating to national and international regulations, guidelines, investigator interactions and timelines
- Recruits, hires, mentors and manages direct reports and supports their professional development
- Leads cross-functional study management team (SMT) and should have good influencing skills with study stakeholders
- Collaboration with colleagues in Clinical Operations, Medical Affairs, Pharmacovigilance & Epidemiology, Project Management, Regulatory, Biometrics and Clinical Research globally ensuring delivery of assigned studies
- Travels nationally and internationally as required
- Excellent interpersonal skills, ability to lead multifunctional teams, ability to manage staff and mentor junior staff is required
- 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
- Proven ability for successful study implementation and completion
- Financial Accountabilities for Clinical Trial Budgets
- Recognizes and escalates critical issues in a trial that may impact the strategic business or financial goals of the Company's overall business
- Ability to motivate teams and drive performance
Experience and Skills:
- At least 10+ years of experience and a RN (2 or 3 year certificate) or BS/BA in a relevant scientific discipline
- At least 8+ years of experience and a Masters\' degree or higher; scientific discipline preferred
- Experience in company sponsored clinical trial management is essential.
- Experience in Phase IV and non-interventional studies preferred
- Experience in Investigator Sponsored & Collaborative Research would be beneficial
- Experience in the provision of compassionate use would be beneficial
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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.
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