Sr. Director, Biomarker Sciences - IVD

Sr. Director, Biomarker Sciences - IVD
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

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The Biomarker Sciences department is responsible for biomarkers and diagnostics across all Therapeutic Areas and all phases of development. In this exciting expansion phase of our portfolio we are seeking an individual experienced in transitioning exploratory biomarkers to marketed IVDs to establish and grow this discipline within the department as a hands-on leader. We work in a dynamic, multidisciplinary matrixed team environment and the successful applicant will have demonstrated ability to effectively communicate and build relationships with a broad range of key stakeholders internally and externally to ultimately deliver IVDs associated with our therapies for the patients we serve.

Biomarker Sciences at Gilead Sciences

The Biomarker Sciences Department is part of Gilead's Development organization, and leads early and late stage clinical biomarker, translational and development activities for the pipeline including diagnostic partnering and life cycle management.

Essential Duties and Job Functions

• Define the diagnostic strategy commensurate with the program clinical development plan through integration of functional stakeholder input
• Develop project plan with third party diagnostic partner and key internal stakeholders that includes resource identification, budget, site (including CRO) and regulatory requirements to meet program goals and clinical timelines
• Establish and lead the Diagnostic Sub Team responsible for the execution of the diagnostic strategy, leveraging cross-functional expertise through internal partnerships, and with third-party diagnostic partners and central laboratories from inception through regulatory approval in multiple jurisdictions
• Provides expert guidance to multi-disciplinary teams and senior management as a subject matter expert with demonstrated experience developing and launching companion diagnostics in a pharma company aligned with the drug development program

Responsibilities

• This position will report to the Head of Biomarker Sciences and be a member of the Biomarker Sciences Leadership team, Biomarker Sciences & Clinical Pharmacology Extended Leadership team and relevant Development cross-functional teams.
• As a member of the Biomarker Sciences leadership team work closely to ensure alignment and synergies are captured across therapeutic areas.
• Serve as a resource to Biomarker Leads as biomarkers are considered for potential diagnostic applications
• Excellent collaboration, communication, and interpersonal skills are required to engage and be productive within a high achieving team environment.
• Experienced at leading internal cross-functional teams to execute the diagnostic strategy as the Diagnostic Sub Team Lead and successfully co-leading diagnostic partner teams and CROs
• Knowledge of clinical study design associated regulatory requirements and experience with their integration ensuring alignment of diagnostic and clinical timelines including ultimate global roll out and lifecycle management.
• Ability to establish, develop and articulate complex plans for multiple projects in a dynamic environment, working closely with key stakeholders including regulatory and clinical research
• Experience in planning resource allocation and garnering support for its successful execution as well as identifying risks and contingency plans
• Experienced with a range of biomarker/analyte classes and the application of biomarkers within clinical development is desirable.
• Must be able to work independently and effectively on multiple programs in a fast-paced matrixed environment leveraging strong leadership skills to marshal resources from different parts of the organization.
• Must be team and detail-oriented, motivated, and results focused.

Technical Skills

• Demonstrated expertise in oncology, immunology or related field
• Knowledge of biomarker discovery and development, assay development/validation, and application of biomarkers in clinical development.
• Broad understanding of drug discovery and development in both early and late stage
  development and familiarity with regulatory approval process.
• Experience integrating data from multiple sources and identifying critical process variables
• Proven scientific/leadership expertise (working in teams, directly managing people/projects commensurate with a senior level)
• Proven publication record
• Strong verbal and written communication skills
• Understanding of IP, contracting terms and provisions

Experience

PhD and/or post-doc training in the area of oncology, immunology, or other related medical science field with a minimum of 15 years of relevant biotechnology or pharmaceutical industry experience. Candidate must be detail-oriented with excellent record keeping and organizational skills. Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast-paced and dynamic multi-disciplinary environment.

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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 careers@gilead.com opens new window" target="_blank" href="https://apptrkr.com/get_redirect.php?id=2521097&targetURL=mailto:careers@gilead.com">careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b

For more information about equal employment opportunity protections, please view the EEO is the Law' 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:
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