Senior Director, Clinical Operations
Senior Director, Clinical Operations
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Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.
Job Description
EXAMPLE RESPONSIBILITIES:
- Provides input into country 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.
- 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) within the country.
- Develops implements manages and ensures completion of clinical trials within country designated budgets and timelines.
- Sets the country strategic vision for assigned clinical trials / programs by working cross-functionally with all relevant stakeholders.
- Assesses on-boards and manages country 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 country strategic implementation of the global Clinical Development Program(s) for specific programs as a member of the Clinical Sub-Team dependent upon the programs priority and breadth for the country.
- Participates in global Study Management Teams (SMTs) as needed and influences all relevant stakeholders as to country requirements and enrollment needs.
- Performs country 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 country regulations guidelines and investigator interactions.
- Keeps all stakeholders appropriately and timeously advised on all aspects of project status and any issues.
- Partners with the country General Manager and other key local stakeholders to ensure seamless execution.
- Ensures building of strong local site partnerships (Sponsor Partner of Choice) through management of the Clinical Site Partners.
- Uses all available tools to track oversee and communicate on program status to all key stakeholders.
- Contributes leadership input into all local 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.
- Contributes to standard operating procedure (SOP) development implementation and training where local specifications are needed.
- Ensures teams work complies with established country practices policies and processes and any regulatory or other local requirements.
- People Leader Path: Hires develops and retains diverse top talent on the team. Sets clear expectations for the team and individuals direct reports. Coaches direct reports on their performance development and career interests. May play a central role in developing other people leaders.
REQUIREMENTS:
We are all different yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Minimum Education & Experience
- BA / BS / RN with 12 or more years relevant clinical or related experience in life sciences. Or MA / MS / PharmD / PhD with 10 or more years relevant clinical or related experience in life sciences.
- Typically has a minimum of 10 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.
- 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 Associate Director (AD) grade 30 position with demonstrable proficiency.
Knowledge & Other Requirements
- Expert knowledge of various disease or therapeutic areas as evidenced by independently applying that expertise to study management leaders and oversight for multiple clinical studies across multiple clinical programs particularly Phases (Ph 1 3. Mandatory Post Marketing) across the country.
- 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 Harmonization 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.
- Plays a lead role in proactively managing significant change efforts as part of the complex projects managed.
- As required the ability to travel.
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For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Exec
Employment Type
Full-Time
