Associate Director, Clinical Operations
Associate Director, Clinical Operations
United States - New Jersey - Morris PlainsUnited States - Washington - Seattle
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 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
We are seeking a talented, experienced, and highly motivated candidate to join the
Oncology Clinical Operations team. The candidate must have the ability to work independently, assess and set program strategy, and effectively lead in a dynamic, fast-paced environment.
Specific Responsibilities and Skills for Position:
- Demonstrated expertise in the leadership and oversight of an Oncology platform/master protocol trial, including setting the strategic vision, working cross functionally to implement, and assess and onboard appropriate vendors to ensure success
- Provides leadership, guidance & oversight, and therapeutic expertise for the successful management of all aspects international clinical trials. Demonstrated ability to develop, implement, manage, and complete international clinical trials within designated program budgets and timelines
- Contributes to the strategic implementation of the Clinical Development Program(s) for specific program(s) as a member of the Clinical Sub Team and the Global Development Team (dependent on the program's priority and breadth). Leads cross-functional Study Management Team and has strong influencing skills with stakeholders
- Proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external collaborators, both a written and verbal. Understands Change Management principles, and proactively seeks alignment on messaging
- Performs strategic analysis of project status and issues, ensuring robust risk mitigation strategies are in place, and communicates to appropriate stakeholders. Anticipates complex obstacles and implements solutions to achieve project goals.
- Responsible for financial oversight of the program, requiring a strong financial acumen; proactively partners cross-functionally for updates to timelines and budgets. Development of RFPs, selection of CROs/vendors, and management of external resources
- Participates in development of Clinical Protocols, Clinical Study Reports, INDs, NDA/BLAs, abstracts, manuscripts, and presentations, as well as other clinical, regulatory, and safety documents.
- Effectively solves problems and uses judgment relating to national and international regulations, guidelines, and investigator interactions
Management & Leadership:
- Sits on the Oncology Extended Leadership Team, providing input into the leadership and management of the Clinical Operations Oncology department
- Recruits, hires, mentors, and manages CPA/CTMA/CTM/CPM direct reports and supports their professional development. Proficient in line management, mentorship and development of team members. Experience as the manager of Managers is preferred.
- Ability to initiate, participate in, and lead departmental or interdepartmental strategic initiatives. Functional expertise to initiate, author, or contribute to procedural document development & reviews, implementation and training
- Travels nationally and internationally, as required
- Excellent interpersonal skills, demonstrated ability to lead multifunctional teams, ability to manage staff, and mentor junior staff is required. Ability to motivate teams and drive performance
- Strong communication and influencing skills, and the ability to create a clear sense of direction and drive the team forward
- 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
- Demonstrates Financial acumen associated with the accountability 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
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
- Prior Oncology clinical trial experience and experience in platform/master protocol trials is required
- Position is office-based in Foster City CA, Seattle WA, or Morris Plains NJ at least 2 days per week
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 email@example.com 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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