Supervisory Medical Director
Centene Corporation
Senior Medical Director, Clinical Development
Amylyx Pharmaceuticals
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Lead late-stage, pivotal clinical development program and potentially additional programs for the same molecule
- Provide medical monitoring for assigned clinical trials in serious endocrine conditions, neurodegenerative and/or rare disease
- Develop and implement Clinical Development Plan including clinical study design, execution, and interpretation of study data
- Interact within a multi-disciplinary, matrix work group including research, pharmacology, drug discovery, regulatory, operations, statistics, CROs, and external experts
- Participate in translational activities, operationalize studies, and monitor data in real time to ensure study integrity
- Proactively identify issues in trial conduct and perform medical review and analysis of data for data cleaning, regulatory documents, and publications
- Produce high-quality program documents including protocols, Investigator Brochures (IBs), clinical study reports, briefing documents, and drug labels
- Develop and maintain relationships with internal stakeholders, global medical expert community, regulatory authorities, alliance partners, and vendors
- Lead a small team of clinical scientists and physicians and report to the Senior VP of Clinical Development
- Contribute to business development activities and organizational initiatives in Clinical Development
Requirements
- MD required
- Experience with late-stage clinical development and drug development in rare diseases strongly preferred
- 4+ years of experience in leading clinical development programs in the biotechnology/pharmaceutical industry with a proven record of achievements
- Ability to think critically and demonstrate troubleshooting and problem-solving skills
- Demonstrated leadership and team building skills as well as the ability to perform effectively in a multi-disciplinary environment
- Ability to lead directly and by influence, including strong interpersonal, problem solving, conflict resolution and analytical skills in a matrix environment
- Excellent communication skills (oral and written) and organizational skills
- Ability to travel internationally and domestically
- Access to a work setting that enables meeting role requirements (privacy, reliable internet, phone, video conferencing) at remote location
- Applicants residing in Alaska, Arizona, Delaware, Hawaii, and Kansas will not be considered (due to health insurance and state tax regulations)
