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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s 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 we’re 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
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 and oversee clinical studies within a program. You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross-functional team members. You will oversee and be responsible for the successful execution of the biomarker and bioanalytical strategy of 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:
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 individual direct reports. Coaches direct reports on their performance, development and career interests.
Acts as team leader and builder; providing expertise, guidance and oversight for the successful implementation of biomarker and bioanalytical strategy for clinical trials and programs within assigned TA(s).
Serves as the key point of contact with internal and external stakeholders, for successful implementation of biological sample analysis strategy in Gilead programs within assigned TA(s), within designated program budgets and timelines.
Establishes strong cross-functional relationships and exhibits strong leadership skills with counterparts in other functional teams (e.g., Biomarker Sciences, Clinical Pharmacology, Vendor Outsourcing, Clinical Operations, and Data Management) to ensure efficient execution of the study biomarker & bioanalytical strategy.
Serve as a vendor issue escalation point of contact for studies under the assigned TA(s) and support vendor governance programs.
Proactively identifies potential operational challenges and provides resolution plans to ensure the biomarker and bioanalytical strategy remains on track; manage multiple programs simultaneously and efficiently.
Manage cross-functional teams by clearly defining objectives and goals; cultivate stakeholder relationships to ensure efficient teams.
Participates in and/or leads departmental or interdepartmental strategic initiatives, including contribution to the development of new systems and processes that help improve department/company performance.
As assigned, initiates, authors or otherwise contributes to standard operating procedure (SOP) development, implementation and training.
Work with cross functional teams including internal and external partners to ensure inspection readiness and support regulatory audits as needed
Resolves issues as needed within national and international regulations and guidelines.
Ability to understand, interpret and explain protocol requirements to others
Assists in determining the activities to support a study, program, or project’s priorities within functional area and across TAs
Responsible for forecasting biomarker and bioanalytical budget for clinical studies within assigned TA(s)
May serve as a resource for others within the company for Biomarker and Bioanalytical Operations clinical trials management expertise
May represent the company at professional events
May represent the department at cross-departmental events
Ensures team’s work complies with established practices, policies and processes, and any regulatory or other requirements.
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 8 or more years’ relevant clinical or related experience in life sciences. Or, MA / MS / PharmD / PhD with 6 or more years’ relevant clinical or related experience in life sciences.
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.
Must have a demonstrated ability to successfully develop, implement, manage and complete execution of biomarker and bioanalytical strategy in clinical trials
Proven ability to successfully start-up, manage and close-out clinical studies, including authoring clinical study and regulatory documentation and SOPs.
Experience developing RFPs and selection and selection and management of CROs or central and specialty lab vendors.
Typically has some experience managing direct reports.
Meets all requirements for Senior Clinical Trial Manager (Senior CTM) grade 28 position with demonstrable proficiency.
Knowledge & Other Requirements
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 documentation.
Functional expertise to initiate, author, or contribute to SOP development, implementation and training
Critical reasoning skills including the identification and resolution of complex problems
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.
The salary range for this position is: $177,905.00 - $230,230.00. Gilead 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
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.