Cerecin is seeking a highly motivated and hands-on Medical Director to join our dynamic team. This role requires an individual who thrives in a collaborative environment and is deeply involved in day-to-day operational activities. The Medical Director will play a critical role in advancing our clinical development programs, contributing directly to protocol writing, scientific rationales, medical articles, and other essential documents.
Position Overview:
Provide leadership and direction for all clinical and regulatory activities, including preparation of clinical development plans, protocol design, and assessment of study results to meet commercial, regulatory, and scientific objectives. Provides expert advice regarding domestic and international regulatory submission requirements and strategies.
- Hands-On Leadership: Actively participate in the development of 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, scientific rationales, publications, and white papers.
- 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.
- Clinical 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
Position Responsibilities:
· Formulates and implements clinical strategies to enhance the marketability of the company’s products while ensuring strong interdepartmental collaboration.
· Directs and manages internal resources, external partners, consultants, contract research organizations (CROs), central laboratories, manufacturing, clinical trial packaging, IVRS vendors and other clinical research vendor’s participation in the conduct of clinical trials.
· Contributes to the development of clinical trial protocols; Works with the project team to develop appropriate timelines, budgets and resources to meet all trial objectives; Oversees execution of all clinical trial protocols, including investigator initiated trials.
· Participates in the assessment, qualification, and recommendation of clinical trial vendors (e.g., Contract Research Organizations [CROs], laboratories, etc.) and consultants.
· Manages and directs the preparation and establishment of Master Services Agreement and Work Orders with CROs, clinical research vendors, and other research professionals.
· Monitors progress of clinical trials and how they are conducted, recorded and reported versus the protocol, standard operation procedures (SOPs) good clinical practices and other applicable regulatory requirements and timelines.
· Develops and maintains budgets to support clinical trials, regulatory submissions, licenses and other regulatory and clinical activities.
· Prepares and presents summaries of clinical/regulatory status reports as required.
· Reviews clinical database management and statistical analysis plans to maintain data integrity and to ensure compliance with all applicable regulatory guidelines.
· In collaboration with clinical investigators, drafts, edits, and reviews clinical study manuscripts for publication in peer-reviewed journals.
· Encourages, develops, edits and reviews departmental and/or investigator publications in support of Cerecin products.
· Directs and participates in the preparation of regulatory documents, including but not limited to: Dossiers, Investigator Brochures, Clinical Study Reports, Package Inserts, promotional materials, and post-marketing safety reports as appropriate.
· Oversees outsourced Medical Information program for the company’s commercially available products to ensure the highest level of satisfaction for physicians, their patients, and caregivers.
· Oversees outsourced product safety program for the company’s commercially available products
· Reviews and updates product label copy, promotional and advertising materials and manuscripts for publication.
· Leads routine interactions with the FDA and international authorities on submission matters. Liaisons with marketing and sales force for appropriate advertising and promotional activities.
· Manages and provides recommendations regarding clinical/medical affairs department budgets and resource requirements.
· Manages direct reports including recommendations and justifications for staffing and training needs.
· Develops and maintains the Clinical and Regulatory Affairs infrastructure including all associated policies, procedures and standard operating procedures (SOPs) to optimized Clinical and Regulatory Affairs activities.
· Acts as medical monitor as required on clinical trials and reviews all medical data from clinical studies
· Represents the company at medical meetings, conferences, outreach meetings at key institutions, and in interactions with thought leaders.
· Maintains knowledge of disease areas within the company’s focus, stays current on leading edge products, development efforts and provides perspective to the business on the treatment landscape.
Experience Requirements:
· M.D. with minimum 3 year in clinical practice. Specialty training in Neurology a bonus
· Must have at least five (5) years experience managing a Clinical department at a Director level.
· It is strongly preferred to have a minimum of 10 years experience in clinical/medical/regulatory; coupled with 10 years of management experience. A minimum of 5 years managing direct reports is required.
· Expert knowledge of the biomedical industry, disease management, and industry trends
· Comprehensive knowledge of FDA and international agency guidelines; recent knowledge of China regulatory processes and guidelines is a bonus
· Adaptability to changing regulatory environment
Skill Requirements:
· Substantial previous management experience in clinical/regulatory/medical affairs
· Strong interpersonal/group skills with demonstrated ability to motivate and direct others
· Education, training, and/or demonstrated knowledge of Good Clinical Practice (GCP) and regulations/ guidelines/guidance/processes of relevant global regulatory authorities are required.
· Proficiency in supervising, managing performance and developing and mentoring individuals
· Innovative problem-solver who fosters collaboration with other project teams within the organization
· Excellent oral and written communication skills
· Detail oriented and dedicated to diligent follow-up through project completion
· Works independently with little or no supervision
· Computer proficient in applications including Word, Excel, and PowerPoint, etc.
Education Requirements:
· MD, MBBS or equivalent
