Associate Director, Clinical Operations

Gilead Sciences•Parsippany, NJ

3d•$177,905 - $253,220

About The Position

Clinical 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 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. In this role you will either act as an individual contributor or will be assigned people leader responsibilities [People Leader Path], according to skill set and business need. The proportion of your time allocated to study activities will be adjusted accordingly. People Leader Path: You will lead a team of direct and/or indirect reports

Requirements

Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD/PharmD and 2 Years' Experience

Nice To Haves

Prior oncology clinical trials experience with at least 3+ years’ experience in the design and delivery of Phase 1 first‑in‑human (FIH) oncology clinical trials.
Relevant clinical or related experience in life science
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.
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.
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

Responsibilities

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.
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.
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