POSITION OVERVIEW:
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.
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 manage a team of direct and potentially indirect reports. You will oversee and be responsible for the successful execution of studies and/or multiple studies within a program or multiple programs, including financial responsibility. You will be responsible for the resource management of studies, including ongoing assessment of resource needs and optimal deployment of resources to support a fluid ‘One Ops’ workforce. You will participate and engage in Clinical Operations and/or cross-functional organizational change initiatives. You may act as the business process owner (BPO) and/or serve as a subject matter expert for 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 reports and may have 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.
- May provide 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.
- Acts as team leader and builder; providing guidance and oversight for the successful management of all aspects of clinical trials within designated program budgets and timelines.
- Leads cross-functional Study Management Teams (SMTs) and influences all relevant stakeholders.
- Partners with cross-functional teams manage, adjust and revise project timelines and budgets as needed.
- Communicates project status and issues and ensures project team goals are met in alignment with project decisions. Escalates issues as needed.
- Participate in the development of all study-related documentation, including study protocols.
- Participates in the selection and management of contract research organizations (CROs) / vendors, including development of requests for proposals (RFPs).
- Anticipates obstacles and difficulties and implements solutions to achieve project goals, including risk assessment and mitigation strategies.
- Resolves issues as needed within national and international regulations and guidelines.
- Uses all available tools to track, oversee and communicate on program status to all key stakeholders.
- Participates in and/or leads departmental or interdepartmental strategic initiatives.
- As assigned, initiates, authors or otherwise contributes to standard operating procedure (SOP) development, implementation and training.
- Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.
- Ensures team’s work complies with established practices, policies and processes, and any regulatory or other requirements.
Basic Qualifications:
Bachelor's Degree and Eight Years' Experience OR Masters' Degree and Six Years' Experience OR PhD / PharmD
Preferred Qualifications:
- Typically has a minimum of 4 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 some experience managing direct reports.
- Proven ability to successfully start-up, manage and close-out clinical studies, including authoring clinical study and regulatory documentation and SOPs.
- Advanced knowledge of one or more disease or therapeutic areas, as evidenced by independence in designing, implementing and managing study team plans, deliverables and resource management.
- 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.
- Proven ability to effectively author clinical study and regulatory documentation.
- Ability to lead and influence programs, projects and/or initiatives.
- Strong interpersonal skills and understanding of team dynamics.
- Proven ability to work successfully in a team-oriented, highly-matrixed environment.
- Demonstrated effectiveness coaching, guiding and directing the work of others, effectively managing performance of others, and developing team capabilities.
- Demonstrated effectiveness in proactively managing change.
- Strong communication and organizational skills.
- 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 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
