Career CategoryClinical
Job DescriptionPrecision Medicine Global Biomarker Lead - Rare Disease What you will doLet's do this. Let's change the world. In this vital role within the Precision Medicine Unit, the Global Biomarker lead will serve as a key member of Amgen's cross-functional product teams, driving biomarker strategies that align with Precision Medicine goals.
We are seeking a highly motivated and experienced senior principal scientist with expertise in clinical biomarker research and drug development in rare diseases and/or autoimmunity and inflammation to develop and execute scientifically robust precision medicine strategies that are integrated with global development strategies. The successful candidate will also oversee assay readiness, vendor management, and interpretation of biomarker data generation, while partnering closely with clinical development, research, and medical affairs colleagues.
Key Responsibilities:- Lead the development and execution of robust program-specific clinical biomarker strategies to inform target engagement, pharmacodynamics, mechanism of action, and patient selection across early and late stage programs
- Serve as precision medicine subject matter expert within product evidence generation teams to deliver precision medicine and translational medicine approaches to enable strategic alignment and delivery of high-quality biomarker datasets
- Responsible for biomarker elements in clinical protocols, biomarker analysis plans, regulatory submissions, investigator meetings, advisory boards and publications
- Lead and partner with biomarker technical sub-teams to plan all components of clinical biomarker strategy implementation including specialty vendor evaluations, biomarker budget and contract planning, biomarker and pharmacodynamic sample operations, biomarker data analysis plans, and cross-functional data sharing.
- Interpret and communicate key clinical biomarker findings in an impactful way to cross functional and non-technical stakeholders, including Precision Medicine teams, product teams, R&D leadership, external scientific congresses, and lay audiences.
- Establish and implement biomarker studies and collaborations with academic laboratories/KOLs
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:Doctorate degree in a bioscience or medical discipline and 3+ years of industry experience Or
Master's degree in a bioscience or medical discipline and 6+ years of industry experience Or
Bachelor's degree in a bioscience or medical discipline and 8+ years of industry experience
Preferred Qualifications:- PhD in a relevant field; PharmD, MD, or equivalent considered. Minimum 5+ years of relevant experience, ideally in industry
- Experience in developing program-based clinical biomarker strategies and its execution while supporting cross-functional clinical study teams
- Strong expertise in rare disease, autoimmunity, inflammation, cell biology, and genomics
- Strong written and verbal communication skills with experience drafting technical reports, clinical documents, and biomarker publications, and interpreting and communicating biomarker results to cross-functional teams and R&D leadership
- Experience implementing a broad array of biomarker platforms and technologies including biomarker assay development and qualification, analysis of clinical samples, and managing biomarker assay outsourcing processes with external vendors and CROs for clinical stage programs
- Experience in managing direct and dotted line reports, as well as matrix management of staff through team leadership
- Experience working effectively in a globally dispersed team environment with cross-cultural partners
- Experience with global programs and regulatory filings (IND/CTA/NDAs) is a plus
- Poise and professionalism with strong communication and influencing skills in a dynamic environment
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
SponsorshipSponsorship for this role is not guaranteed.
Salary Range166,523.50USD -225,296.50 USD
