Clinical Development Medical Director, Early Development – Cardiometabolic

Amgen•Thousand Oaks, CA

8d•$274,789 - $371,773

About The Position

The Clinical Development Medical Director will lead the early-phase clinical development of cardiometabolic/general medicine compounds, from first-in-human studies through proof-of-concept. The role collaborates with cross-functional teams to design and deliver early-phase clinical trials, supporting protocol development, study start-up, data review, monitoring, and analysis.

Requirements

MD or DO degree from an accredited medical school.
At least 2 years of industry or academic/basic sciences/clinical research experience.

Nice To Haves

Board certification or eligibility.
Residency training in Cardiology, Internal Medicine, or a relevant subspecialty.
Understanding of cardiometabolic and general medicine pathophysiology.
Experience in basic research and/or clinical trial methodology.
At least 4 years of relevant drug development experience in the pharmaceutical industry and/or academia, preferably in early-stage clinical trials.
Experience collaborating with pharmaceutical sponsors.
Experience designing, monitoring, and implementing clinical trials and interpreting trial results.
Demonstrated leadership qualities and ability to conduct studies as part of a team.
Experience in a matrix environment, contributing to decision-making and alignment to meet challenging timelines.
Publication track record.
Excellent interpersonal and presentation skills, with the ability to communicate effectively with internal stakeholders, external partners, and collaborators.

Responsibilities

Contribute to the design and implementation of early clinical development strategies for cardiometabolic/general medicine therapeutic candidates.
Contribute to preparing clinical development plans, study protocols, informed consents, Investigator Brochures, and submissions to Ethics Committees and regulatory agencies.
Review and evaluate clinical study safety, efficacy, pharmacodynamic, and pharmacokinetic data.
Contribute to the strategy and use of clinical biomarkers to facilitate drug development.
Collaborate with Amgen Precision Medicine, Research, Late Development, Regulatory, Safety, and Commercial colleagues.
Contribute to evaluating external licensing or partnering opportunities in cardiometabolic/general medicine therapeutic areas.
Collaborate with external experts to provide biomedical expertise and strategic guidance to cardiometabolic/general medicine Early Development teams.

Benefits

Health and welfare plans for staff and eligible dependents.
Retirement and Savings Plan with company contributions.
Medical, dental, and vision coverage.
Life and disability insurance.
Flexible spending accounts.
Discretionary annual bonus program (or a sales-based incentive plan for field sales representatives).
Stock-based long-term incentives.
Award-winning time-off plans.
Flexible work models where possible.
Career development opportunities.