Head of Biomarker Operations, WCH
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Job Location:
San Francisco, CA - USA
Monthly Salary:
$ 205000 - 282000
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
About This Role
The Head of Biomarker Operations West Coast Hub (WCH)is a strategic and operational leader responsible for driving the biomarker operations function across the WCH therapeutic portfolio. This role oversees a team of Biomarker Operations Study Managers and ensures the successful execution of biomarker and bioanalytical strategies that support clinical development from early to late-stage programs including multiple registrational studies. Reporting directly to theHead of Biomarkers and Clinical Pharmacology WCH this role is a key interface with cross-functional stakeholders including Clinical Biomarkers Clinical Operations Biometrics Clinical Pharmacology Regulatory Quality and other internal and external partners. The successful candidate will bring deep operational expertise scientific acumen and leadership presence to ensure the delivery of high-quality biomarker and bioanalytical data that informs clinical development and regulatory strategy.
Key Responsibilities:
Build lead and mentor a high-performing team of Biomarker Operations Study Managers
Define and drive the biomarker operations strategy for the WCH programs ensuring alignment with goals and priorities
Provide strategic input into biomarker and bioanalytical planning execution and resource allocation across multiple programs and studies
Serve as the primary liaison between biomarker operations and WCH Clinical Operations Data Management Quality and other key cross-functional leaders
Champion integration of biomarker operations into clinical trial design and execution ensuring seamless coordination across functions
Represent biomarker operations in key WCH forums program teams and strategic planning discussions
Establish and oversee best practices for biosample collection processing storage and testing strategies that are tailored to protocol requirements
Ensure robust vendor oversight and management of central and specialty labs to meet quality and timeline expectations
Lead process improvement initiatives to enhance operational efficiency data integrity and compliance with GCP GLP and GCLP standards
Ensure timely delivery of high-quality biomarker and bioanalytical data for registrational studies consistent with the sample collection and assay plans and clinical protocols to support regulatory filings and approval
Partner with Quality and Compliance functions to uphold standards across biomarker operations ensuring audit readiness and adherence to internal and external regulatory expectations
Ensure biomarker data is delivered in a format and quality suitable for regulatory submissions and scientific publications
Provide expert input into protocol development informed consent forms (ICFs) and data management plans
Qualifications:
Bachelors degree in a biological science or related technical field with 15 years experience or advanced degree with 12 years experience
Extensive industry experience in clinical biomarker operations biomarker/bioanalytical sciences clinical operations or related disciplines in the clinical trial setting
Proven leadership experience managing teams and driving strategic initiatives in matrixed fast-paced clinical development environment
Deep understanding of clinical trial operations across all phases of development biomarker strategy and specialty lab testing (PK ADA exploratory biomarkers)
Experience with data integration and transfer processes between testing vendors and internal data systems
Expertise in biomarker and bioanalytical assay platforms (e.g. flow cytometry immunoassays genomics etc)
Familiarity with contracting processes including Master Service Agreements and Statement of Work development
Demonstrated success in cross-functional collaboration vendor management and GCP/GLP/GCLP compliance
Experience supporting biomarker and/or bioanalytical operations for registrational studies and regulatory filings
Exceptional organizational communication and stakeholder engagement skills
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.
Regular employees are eligible to receive both short term and long-term incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.
In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social well-being; including but not limited to:
- Medical Dental Vision & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10000 per calendar year
- Employee Resource Groups participation
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.
Required Experience:
Director
Key Skills
- Succession Planning
- Growing Experience
- Expense Management
- Management Experience
- Rackspace
- Laboratory Management
- Senior Leadership
- Operations Management
- Relationship Management
- Leadership Experience
- negotiation
- Taxonomy
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patientsÂ’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
