Associate Director, Clinical Operations – OncologyUnited States - California - Foster City, United States - New Jersey - Morris Plains, United States - Washington - SeattleClinical Development & Clinical OperationsRegular
Clinical Operations is responsible for the execution of 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.
Led by a team of well-established Clinical Operations professionals, careers within the Clinical Operations team offers individuals the opportunity to develop their knowledge & experience rapidly whilst enjoying a supportive and team-focused working environment. Gilead’s operational model allows each Clinical Operations professional to make a genuine impact on the business and ultimately our ability to deliver live changing therapeutics to those in need.
Specific Responsibilities and Skills for Position:
- Provides leadership and oncology 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 phase oncology 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 Clinical Trial Manager/Clinical Program Manager/Clinical Trial Management Associate direct reports and supports their professional development
- Leads cross-functional study management team and must have good influencing skills with study stakeholders
- Travels nationally and internationally as required
Knowledge & Other Requirements
- Excellent interpersonal skills, and demonstrated ability to lead is required
- Oncology development experience
- 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
- Has an expert-level of knowledge of one or more disease or therapeutic areas, as evidenced by independence in assuming study management leadership and oversight for multiple clinical studies across a worldwide clinical program.
- Routinely drives to resolve cross-functional issues related to study execution.
- Lead by Example leadership mentality
- Typically reports to Director or above.
- Provides matrix management and leadership to multiple larger-scale study teams.
- Acts as a process improvement and innovation champion; identifying opportunities to enhance operational excellence / innovation and staff to drive initiatives, e.g., tech and innovation collaborations. Drives and/or leads departmental and interdepartmental strategic initiatives.
- Actively contributes and may represent Clinical Operations in project strategy meetings or Global Development Team (GDT) as applicable.
- Actively consults on short- and long-term TA / FA strategy and operational plans as appropriate, including consistent messaging upon implementation.
- Leads highly complex assignments that enable multiple functions, teams and therapeutic area clinical programs to achieve their objectives within targeted timelines and allocated resources.
- Champions our Leadership Commitments and Values with an appropriate balance of portfolio delivery, resource management, and organizational excellence / innovation while being able to effectively manage more complex assignments.
- With little to no direction, determines how to structure and manage assigned studies across a program(s) to ensure project deliverables are completed on-time, within-budget and to the quality expected
- Develops change management skills in other team members by providing proactive change management leadership and guidance.
Required Education & Years of Experience and Skills:
- 10+ years of experience in clinical operations and a BS/BA or higher degree in a relevant scientific discipline. MS/MA or higher will need 8+ yrs experience in clinical operations
- Minimum of 6 years’ cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing study management or project teams.
- Experience in company sponsored clinical trial management is required
- Oncology development experience required