Clinical Development Director – Early Development, Cardiometabolic/General Medicine

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the initial phases of clinical development for compounds, ranging from first-in-human studies to proof-of-concept stages.

• Collaborate with teams to enhance the design and execution of early phase clinical trials.

• Assist in the development of protocols, initiate studies, and engage in data review, monitoring, and analytical activities.

• Play a key role in shaping and executing the early clinical development strategy for therapeutic candidates in cardiometabolic and general medicine.

• Aid in the preparation of clinical development plans, clinical study protocols, informed consent documents, Investigator Brochures, and submissions to Ethics Committees and regulatory agencies.

• Assess and analyze clinical study data related to safety, efficacy, pharmacodynamics, and pharmacokinetics.

• Contribute to the strategic use of clinical biomarkers to streamline the drug development process.

• Actively partner with colleagues from Amgen Precision Medicine, Research, Late Development, Regulatory, Safety, and Commercial teams.

• Assist in the assessment of external licensing or partnership opportunities in the cardiometabolic and general medicine sectors.

• Collaborate with external experts to provide biomedical insights and strategic support to the Early Development teams focused on cardiometabolic and general medicine.

⛳️ Requirements

• MD or DO degree from an accredited medical institution AND 2 years of experience in industry, academic/basic sciences, or clinical research.

• Board certification or eligibility in Internal Medicine, Cardiology, or Endocrinology.

• Completed residency training in Internal Medicine with a relevant subspecialty.

• Familiarity with the pathophysiology of cardiometabolic and general medicine.

• Background in basic research and/or clinical trial methodologies.

• More than 3 years of pertinent drug development experience in the pharmaceutical sector and/or academia, particularly in early-stage clinical trials.

• Experience working in collaboration with pharmaceutical sponsors.

• Proficiency in designing, monitoring, and implementing clinical trials, as well as interpreting trial outcomes.

• Proven leadership skills; able to conduct studies within a team setting.

• Experience within a matrix environment, contributing to decision-making and alignment to meet tight deadlines.

• A record of publications.

• Outstanding interpersonal and presentation abilities; capable of effective communication with both internal stakeholders and external partners and collaborators.

🏝️ Benefits

• A comprehensive employee benefits package that includes a Retirement and Savings Plan with generous contributions from the company.

• Group medical, dental, and vision insurance coverage.

• Life and disability insurance options.

• Flexible spending accounts.

• A discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.

• Long-term incentives based on stock.

• Award-winning time-off policies.

• Flexible working models where feasible.