Senior Manager Clinical Biomarkers & Diagnostics - Beigene IVD

Amgen is a leading global biotechnology company, with a mission to serve patients around the world. As a science-based, patient-focused organization, we discover and develop innovative therapies to treat serious illnesses. Our medicines have made a dramatic difference in the lives of millions. To underpin our commitment to serve patients, Amgen is developing our Translational Science focus with modern molecular and cellular science and pathology laboratories, designed to discover and develop valuable biomarkers in support of our clinical programs.

The Department of Clinical Biomarkers & Diagnostics (CBD) at Amgen in South San Francisco (ASF) is seeking a highly motivated Senior Manager Clinical Biomarkers & Diagnostics to enable the development of the Dx operating model between Amgen and BeiGene.

Accountabilities

The person in this role will be a key contributor to the CBD function and the Diagnostic capability.
Amgen is in active partnerships with the most Diagnostic partners in Amgen's history. This requires dedicated roles to support, track, facilitate the Diagnostic portfolio and continually plan for the future.
This key role supports the Diagnostic Development teams and the Diagnostic Steering committee and all associated deliverables.
This key role develops and supports the Amgen/BeiGene collaboration for all Diagnostic activities and planning.

Responsibilities

Enable the development of the Dx operating model between Amgen and BeiGene and facilitate execution of a change management and transition plan for Dx program activities.
Manage Dx portfolio and forecast Dx demand for the Amgen pipeline using a Dx dashboard tool and process, by establishing an aligned database and a clear, consistent and straightforward updating and approval process covering EO through Marketed Amgen molecules.
Support and oversee Dx partners JPTs and JSCs with key Dx partners as needed until DxDT are being formed and Dx SPMs are hired and onboarded.
Guide clear and robust Dx contracting process with clear R&Rs across functions, i.e., BD, legal, Dx lead.
Own and guide process to ensure functional leads and Dx stakeholders (incl. finance) stay fully informed and up to date on rationale and budget impacts of upcoming Dx contracts and amendments as well as milestone, invoicing status.
Ensure full use of MRD testing allotment under Adaptive Preferred Partnership Agreement: Together with Adaptive, track key performance indicators like sample numbers and turn-around times in regular meetings.
Facilitating cross-functional review and advise to ensure appropriate governance of new and existing Dx strategies at DxSC within the new Dx capability framework.
Enhance Dx partner due diligence process and establish Dx partner score card database by advancing a due diligence tool.

Authority

No budget responsibility.
Decision making authority revolves around managing the DxSC and dashboards for the Dx portfolio.

Outputs

Dx Partnership Portfolio Management.
Run the DxSC and be responsible for scheduling, meeting minutes, and updates.
Oversee the Dx portfolio and manage tracking and dashboards for functional and senior management needs.

Basic Qualifications

Doctorate degree in a scientific discipline with a minimum of 2 years industry experience in a diagnostic, or contract research organization focusing on Companion Diagnostics (CDx) or In Vitro Diagnostics technical development and/or preparation of regulatory filings.
OR
Master's degree in a scientific discipline with a minimum of 6 years industry experience in a diagnostic, or contract research organization focusing on Companion Diagnostics (CDx) or In Vitro Diagnostics technical development and/or preparation of regulatory filings.
OR
Bachelor's degree in a scientific discipline with a minimum of 8 years industry experience in a diagnostic, or contract research organization focusing on Companion Diagnostics (CDx) or In Vitro Diagnostics technical development and/or preparation of regulatory filings.

Preferred Qualifications

Advanced degree with a minimum of 3 years of industry experience in developing and/or manufacturing diagnostic assays, or in clinical operations for or involving a diagnostic test, or other role involving significant technical development in a partnership.

Preference for candidates with experience in oncology diagnostic tests, the diagnostics development process, cGMP manufacturing, and knowledge of US regulatory submission process (PMAs and 510(k)), or regulatory submission processes outside of the US.

Demonstrated project management experience, with the ability to lead multiple activities and resources while maintaining attention to detail.

Good knowledge of diagnostic technologies, including immunohistochemistry (IHC), Next Generation Sequencing (NGS), Flow Cytometry and/or immunoassay.

Anticipates partnering and operational issues.

Strong understanding of pharmaceutical and diagnostic development phases.

Ability to lead, align, motivate, cross-functional, and geographically dispersed stakeholders.

Proficient in MS Office suite, SharePoint Online, and Smartsheet.

Strong analytical and problem-solving skills.

Self-directed, innovative and collaborative spirit, flexible to adapt to a dynamic environment, and resourceful.

Ability to travel (up to 10% of time)

A Fortune 150 company operating in nearly 100 countries around the world, we invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of our patients. That's why, as a member of our cross functional, cross discipline team, we provide you with valuable opportunities to broaden your experience and maximize your potential. Focused on the industry's most compelling scientific discoveries and housed within industry leading facilities within the heart of the world's leading biotechnology hub, our colleagues are growing our pipeline through groundbreaking innovations. We believe in rewarding those who do
rewarding work and are committed to providing careers that can help turn the tide of serious, life interrupting illnesses.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.