Cerecin seeks a dynamic Medical Director to advance clinical development programs. This role requires leadership and collaboration in day-to-day activities.
Position Overview:
Lead medical activities, including clinical development plans, protocol design, and study results to meet commercial, regulatory, and scientific objectives.
Key Responsibilities: - Hands-On Leadership: Participate in developing clinical strategies and ensure their execution through close collaboration with cross-functional teams.
- Medical Writing: Author and review key documents, including clinical protocols, investigator brochures, regulatory submissions, and publications.
- Scientific Expertise: Provide medical insights that shape Cerecin's clinical development programs and ensure alignment with the company's mission to address unmet neurological needs.
- Medical Oversight: Oversee clinical trials by providing medical guidance to ensure scientific rigor and compliance with regulatory standards.
- Stakeholder Engagement: Collaborate with internal teams, external partners, regulatory bodies, and key opinion leaders to advance Cerecin's therapeutic pipeline.
Additional Responsibilities:
- Formulates clinical strategies to enhance marketability of products while ensuring strong interdepartmental collaboration.
- Contributes to developing clinical trial protocols; works with project team to develop appropriate timelines, resources to meet all trial objectives.
- Participates in assessing, qualifying, and recommending clinical trial vendors and consultants.
- Reviews safety and medical database management and statistical analysis plans to maintain data integrity and compliance with applicable regulatory guidelines.
- Drafts, edits, and reviews clinical study manuscripts for publication in peer-reviewed journals.
- Develops, edits, and reviews departmental and/or investigator publications in support of Cerecin products.
- Directs preparation of regulatory documents, including Dossiers, Investigator Brochures, Clinical Study Reports, Package Inserts, promotional materials, and post-marketing safety reports.
- Oversees outsourced Medical Information program for commercially available products to ensure high level of satisfaction for physicians, patients, and caregivers.
- Manages direct reports including recommendations and justifications for staffing and training needs.
- Acts as medical monitor on clinical trials and reviews medical data from clinical studies.
- Represents the company at medical meetings, conferences, outreach meetings at key institutions, and interactions with thought leaders.
