Precision Medicine Global Biomarker Lead

Amgen Inc.; United States; A distancia; USD 140.000 - 210.000; Jornada completa

Descripción de la vacante

Amgen is seeking a Precision Medicine Global Biomarker Lead - Oncology Clinical Biomarkers to plan and execute biomarker research in oncology trials. You will translate advanced biomarker technologies into clinical development and guide biomarker elements across protocols and regulatory submissions.

You will build collaborations with academia and CROs, interpret complex biomarker data, and communicate actionable insights to leadership.

Formación

• Doctorate degree and 3 years of oncology clinical biomarker experience.
• Master’s degree and 5 years of oncology clinical biomarker experience.
• Bachelor’s degree and 7 years of oncology clinical biomarker experience.
• Associate’s degree and 12 years of oncology clinical biomarker experience.
• High school diploma / GED and 14 years of oncology clinical biomarker experience.

Responsabilidades

• Develop and drive clinical biomarker strategies across one or more programs.
• Form hypotheses for patient stratification and pharmacodynamics from trial samples.
• Own biomarker elements in protocols, analysis plans, and regulatory documents.
• Build relationships with academic, KOLs and external partners for biomarker planning.
• Partner with cross-functional teams to drive biomarker innovation at product level.
• Interpret and communicate biomarker findings to cross-functional teams and leadership.

Conocimientos

Oncology biomarker exp

Clinical biomarker strategy

Cross-functional collab

Educación

Doctorate in a relevant field

Master's degree in a relevant field

Bachelor's degree in a relevant field

Associate's degree

High school diploma

Descripción del empleo

Location: United States

Career Category

Finance

Job 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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 - Oncology Clinical Biomarkers

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for planning and executing biomarker research within oncology clinical studies. Your work, using advanced technologies and methodologies, will help in the translation and clinical development of the company's products. Main duties and responsibilities include:

• Develop and drive clinical biomarker strategies, implementation, and execution for one or more programs
• Develop clear and testable hypotheses for patient stratification/selection, pharmacodynamics, mechanism of action and resistance evidence from clinical trial samples to deepen the understanding of disease treatment approaches and for critical decision making
• Responsible for biomarker elements in clinical protocols, biomarker analysis plans, regulatory submissions, investigator meetings, advisory boards and publications
• Build productive relationships with team members, key opinion leaders, academic institutions and external partners for integrating an aligned and prioritized clinical biomarker evidence plan that addresses clinical objectives and/or translational research
• Partner with cross functional stakeholders to drive biomarker innovation at the product level as well as disease or modality level
• Interprets and communicates key clinical biomarker findings as well as next steps to cross functional teams including Precision Medicine teams and leadership

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 and 3 years of industry experience in oncology clinical biomarker experience

OR

• Master’s degree and 5 years of industry experience in oncology clinical biomarker experience

OR

• Bachelor’s degree and 7 years of industry experience in oncology clinical biomarker experience

OR

• Associate’s degree and 12 years of industry experience in oncology clinical biomarker experience

OR

• High school diploma / GED and 14 years of industry experience in oncology clinical biomarker experience

Preferred Qualifications:

• Doctorate degree (PhD and/or MD) with 6+ years industry experience in oncology disease biology and developing biomarker strategies in a clinical development setting
• Demonstrated experience developing and executing pharmacodynamic, predictive, and exploratory biomarker strategies using clinical trial samples to elucidate mechanisms of action and characterize mechanisms of response and resistance.
• Experience assessing and implementing a broad array of biomarker platforms and technologies to support oncology clinical programs
• Proficiency in interpreting and contextualizing biomarker data, synthesizing complex biological findings into clear, actionable takeaways, and communicating them effectively to diverse stakeholders, from scientific peers to senior leadership.
• Clinical development experience working with cross-functional teams conducting clinical trials
• Demonstrated ability to establish and implement biomarker collaborations with academic laboratories/KOLs and CROs
• Demonstrated proficiency in biomarker assay development and qualification, analysis of clinical samples, and leading biomarker assay outsourcing processes with external vendors and CROs
• Experience working effectively and leading in a team environment
• Strong written skills with proficiency in drafting; technical reports, clinical protocol and clinical study reports, submission document response to questions, biomarker publications
• Strong communication skills when presenting strategy, plans and results to leadership
• Demonstrated proficiency in developing and executing biomarker strategies for immuno-oncology agents (checkpoint inhibitors, T-cell agonists/engagers) and/or ADCs

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 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.

In 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 deadline

Amgen 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.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Salary Range

USD - USD