Clinical Development Director – Obesity, Cardiovascular

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

📋 Description

• Deliver clinical and scientific expertise to aid in the development, design, execution, and communication of the global evidence generation strategy for the AMG 133 Phase 3 program.

• Collaborate across functions to convert clinical strategies into study concept documents, protocols, and other relevant materials.

• Contribute clinical insights and oversee the implementation of clinical trials.

• Analyze clinical data and provide interpretations of results.

• Act as a medical monitor for ongoing clinical trials.

• Examine and evaluate clinical trial data for accuracy, completeness, adherence to protocols, and compliance with regulatory standards.

• Engage in safety and regulatory discussions, providing clinical input as necessary.

• Prepare clinical study reports, publications, and submissions for regulatory bodies.

• Build and maintain relationships with key opinion leaders.

• Deliver scientific presentations at advisory boards, scientific conferences, and external committee meetings.

• Report directly to the Global Development Lead for cardiovascular indications.

⛳️ Requirements

• MD or DO degree from an accredited medical institution.

• Minimum of 3 years of experience in clinical research.

• Preferred: Three (3) or more years of clinical research experience within the biopharmaceutical sector.

• Preferred: Five or more years of combined clinical research experience and/or basic science research, along with clinical teaching and patient care activities.

• Familiarity with pharmaceutical product development, product lifecycle management, and commercialization processes.

• Experience in developing study concepts for clinical development and designing clinical trials with cross-functional collaboration, specifically in Phase 2 and/or 3 trials related to obesity, diabetes, or cardiovascular conditions.

• Proficiency in clinical trial medical data review, medical monitoring, and safety evaluation, including the use of electronic aggregate data review tools.

• Experience in drafting high-level documents for regulatory submissions, including clinical regulatory responses.

• Excellent written and oral communication skills, along with strong presentation abilities.

• Strong interpersonal skills and the capacity for problem-solving.

• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, as well as applicable international regulatory requirements.

• Leadership experience or potential to serve as a medical expert in a complex matrix environment.

🏝️ Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with substantial company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off policies.

• Flexible work arrangements, where feasible.

• Opportunities for career development.

• Financial planning assistance with options for retirement savings or other financial goals.

• Support for work/life balance.