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Director, Biomarker - IVD

Santa Monica, CA - $209,865 - $271,590 Full Time Posted by: Gilead Sciences Posted: Wednesday, 15 May 2024
 
For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.At Gilead we believe every employee deserves a great leader.

As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.Job DescriptionJob Description: Title: Director, In Vitro Diagnostics, Biomarker SciencesThe 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 SciencesThe 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 FunctionsDefine the diagnostic strategy commensurate with the program clinical development plan through integration of functional stakeholder inputDevelop 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 timelinesEstablish 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 jurisdictionsProvides subject matter guidance to multi-disciplinary teams in the drug development programResponsibilitiesThis position will report to the Head of Biomarkers-IVD in the Biomarker Sciences Department and be a member of relevant Development cross-functional teams.

Serve as a resource to Biomarker Leads as biomarkers are considered for potential commercial 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 companion diagnostic partner teams.

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 researchMust be able to influence and impact biomarker-IVD strategy of the organization at the highest level.Must possess in-depth knowledge on integrating diagnostic development into the multidiscplinary functions of the company's drug development process.

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 SkillsDemonstrated expertise in oncology, immunology or related fieldKnowledge 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 stagedevelopment and familiarity with regulatory approval process.Experience integrating data from multiple sources and identifying critical process variablesProven scientific/leadership expertise (working in teams, directly managing people/projects commensurate with a senior level)Proven publication recordStrong verbal and written communication skillsUnderstanding of IP, contracting terms and provisionsEducation and ExperiencePhD and/or post-doc training in the area of oncology, immunology, or other related medical science field with a minimum of 12 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.The salary range for this position is: $209,865.00 - $271,590.00.

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

For jobs in the United States: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' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur 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 to apply for this job.SummaryLocation: United States - California - Santa MonicaType: Full time.

Santa Monica, CA, USA
Science
$209,865 - $271,590
Gilead Sciences
AJF/707506537
15/05/2024 00:25

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