Clinical Program Manager, Medical Affairs Research Operations

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

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 worlds 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.

We are seeking a talented experienced and highly motivated candidate to successfully manage Collaborative (CO) and Investigator Initiated Research (IIR) programs across Gileads therapeutic areas. The candidate must have the ability to work independently be an effective leader and an engaged team member in a dynamic fast-paced environment.

This role will be a hybrid office-based role (three days in office) in our headquarters in Foster City CA.

Specific Responsibilities and Skills for Position:

• Provide oversight of IIR & CO portfolio for one of more therapeutic areas. May also serve as Global Therapeutic Area Liaison (TAL)for one or more therapeutic areas

• Understands Medical Affairs structure and liaises regularly with stakeholders

• Understands Clin Ops global structure procedures and geographic differences (TA vs geography differences in publication handling EU/AUS working cross TAs)

• Represents Medical Affairs Research Operations at governance meetings

• Critically evaluates scientific proposal or protocol to identify logistical regulatory and safety implications; highlights potential risks (and proposed mitigations if applicable) to appropriate governance committee

• Maintains overview of ongoing and planned studies ensures appropriate resourcing needs acts as escalation point for study managers for issue resolution.

• Understands rationale for financial variance in Therapeutic Area (TA) and acts as a medical Affairs Research Operations point of contact with Finance team.

• Collaborates and liaises with Medical Affairs Research leadership team to discuss potential process updates as well as simplifications & standardizations to existing processes.

• Provide leadership and support to Study Managers on Investigator Initiated Research (IIR) and Collaborative (CO) Studies including but not limited to: Fair Market Value and feasibility assessment protocol reviewdrug forecasting and supply contract milestone advice tracking and publication follow-up.

• Provide support to Study Managers with issue escalation/resolution as well as resource planning.

• Establish strong partnerships with external investigators and collaborators; and internal stakeholders (e.g. Med Affairs Reg Affairs Development Business Ops PVE Clinical Supply Management); to ensure timely efficient and high-quality study management.

• Identify any best practice opportunities to share across Therapeutics Areas and Gilead sites.

• Good understanding of industry standards for CO and IIR studies and keeps abreast of any new changes and developments which could impact Medical Affairs Research

• Must be able to lead departmental or interdepartmental strategic initiatives

• Provide training to colleagues on process changes/improvements as necessary.

• Experience in managing staff as well as mentoring and developing junior staff is required.

• May contribute to company sponsored Non-Interventional Studies (i.e. retrospective / prospective observational studies patient registries HCP / patient surveys)

• Occasional travel may be required.

• Strong interpersonal communication leadership and influence skills.

• Comprehensive understanding of FDA/EMA regulations ICH guidelines GCP and clinical operations principles.

• Knowledge of global pharmaceutical regulatory requirements and their impact on clinical trials.

• Excellent analytical problem-solving and organizational skills; ability to multitask and meet deadlines.

• Able to work independently and suggest solutions for project issues.

Basic Qualifications:

Bachelors Degree and Six Years Experience

OR

Masters Degree and Four Years Experience

OR

PhD / PharmD

Preferred Qualifications:

• At least 8 years of experience and a RN (2 or 3 year certificate) or BS/BA in a relevant scientific discipline.

• At least 6 years of experience and a Masters degree or higher; scientific discipline preferred.

• Experience in the review and oversight of Investigator Sponsored & Collaborative Research strongly preferred.

• Experience in Phase IV and non-interventional studies preferred.

• Prior Global or large affiliate experience in medical affairs activities preferred

• Prior supervisory/leadership experience preferred.

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.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic 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 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 for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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 apply via the Internal Career Opportunities portal in Workday.