Job DescriptionClinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead's products.
You will typically lead a team of direct and indirect reports. You will oversee and be responsible for the successful execution of more complex studies and/or multiple studies within a program or multiple programs, including financial responsibility. You may be accountable for local or regional oversight / leadership of programs that may span therapeutic areas. You will be responsible for the resource management of multiple studies within a program or multiple programs, including ongoing assessment of resource needs and optimal deployment of resources to support a fluid 'One Ops' workforce. You will lead and/or effectively engage in Clinical Operations, cross-functional and/or country or regional organizational change initiatives and strategy. You will typically act as the business process owner (BPO) and/or serve as a subject matter expert for complex Clinical Operations processes. You will encourage an innovative mindset by championing new ideas and initiatives and incorporating best practices, external benchmarking and standardization across Clinical Operations.
EXAMPLE RESPONSIBILITIES: - Typically manages a team of direct and indirect reports. Hires, develops and retains diverse top talent on the team. Sets clear goals for the team and individuals direct reports. Coaches direct reports on their performance, development and career interests. Plays a lead role in developing other people leaders.
- Provides input into strategic and operational short- and long-range therapeutic area / functional area plans as appropriate, including supporting alignment and communications to other team members upon implementation.
- May sit on the Clinical Operations Extended Leadership Team; providing input into the leadership and management of the Clinical Operations TA team.
- Provides leadership, guidance, oversight and therapeutic expertise for the successful management of all aspects of clinical trials.
- Responsible for the strategic, operational and financial oversight of assigned program(s).
- Develops, implements, manages and ensures completion of clinical trials within designated budgets and timelines.
- Sets the strategic vision for assigned clinical trials / programs by working cross-functionally with all relevant stakeholders.
- Assesses, on-boards and manages contract research organizations (CROs) and other vendors to ensure success of assigned trials / programs, including requests for proposals (RFPs) and selection processes.
- Contributes to the strategic implementation of Clinical Development Program(s) for specific programs as a member of the Clinical Sub-Team and may sit on the Global Development Team, dependent upon the program's priority and breadth.
- Leads cross-functional Study Management Teams (SMTs) and influences all relevant stakeholders.
- Performs strategic analysis of project status and issues; ensuring robust risk mitigation strategies are in place.
- Anticipates complex obstacles and implements solutions to achieve project goals.
- Solves problems relating to national and international regulations, guidelines and investigator interactions.
- Keeps all stakeholders appropriately and timeously advised on all aspects of project status and any issues.
- Uses all available tools to track, oversee and communicate on program status to all key stakeholders.
- Contributes leadership input into all study-related documentation, including study protocols.
- Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.
- Initiates, authors or otherwise contributes to standard operating procedure (SOP) development, implementation and training.
- Ensures team's work complies with established practices, policies and processes, and any regulatory or other requirements.
Basic Qualifications:Bachelor's Degree and Ten Years' Experience
OR
Masters' Degree and Eight Years' Experience
OR
PhD/PharmD and Two Years' Experience
Preferred Qualifications:- Typically has a 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 developing RFPs and selection and management of CROs or other vendors.
- Typically has multiple years' line management experience.
- Proven ability to successfully manage clinical studies within designated program budgets and timelines, including significant expertise in authoring clinical study and regulatory documentation and SOPs.
- Meets all requirements for Clinical Program Manager (CPM) grade 29 position with demonstrable proficiency.
- Expert 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.
- Complete knowledge of full cycle study management, from start-up to close-out.
- Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.
- Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
- Strong financial acumen necessary for the management of clinical trial budgets.
- Proven ability to effectively author clinical study and regulatory documentation.
- Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
- Strong interpersonal skills and understanding of team dynamics.
- Strong communication and organizational skills.
- Strong negotiation and conflict resolution skills.
- Demonstrates strong capabilities in hiring, managing and developing diverse top talent.
- Demonstrated effectiveness in proactively managing change.
- When needed, ability to travel.
People Leader Accountabilities:- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem
The salary range for this position is: $177,905.00 - $230,230.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
