Precision Medicine Global Biomarker Lead , Rare Disease

About this role

Career Category
ClinicalJob Description
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Precision Medicine Global Biomarker Lead - Rare Disease
What you will do
Let’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 you
We 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 us
As 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…