Medical Director, Medical Affairs- CNS/Psychiatry

Job Description: Medical Director, Medical Affairs

Overview: Join our client's team as a Medical Director, Medical Affairs, where you will provide medical, scientific, strategic, and operational leadership. You will play a key role in activities such as generating clinical and scientific data, enhancing therapeutic benefit, ensuring safety and value, collaborating with healthcare professionals, and engaging in medical education and scientific communication. You'll work closely with cross-functional teams to support medical affairs initiatives that promote the safe and appropriate use of our clients' medicines. You will also serve as an advocate for healthcare professionals (HCP) and patients, ensuring that commercial teams receive evidence-based medical input for brand strategies, marketing, and market access activities.

Key Responsibilities:

• Leadership in Medical Affairs: Initiate and lead medical affairs activities, data generation, and dissemination to support the overall medical and scientific strategy.
• Clinical Study Oversight: Lead or support the design, analysis, interpretation, and reporting of scientific content in study protocols, Investigator Brochures, Clinical Study Reports, and regulatory submissions.
• Clinical Trials Management: Oversee clinical trials, ensuring safety issue resolution, statistical analysis interpretation, Principal Investigator selection, and regulatory compliance.
• Safety and Risk Management: Design and execute safety and risk management plans for clinical trials, review and report Adverse Events (AEs) and Serious Adverse Events (SAEs).
• Study Integrity and Enrollment: Monitor study integrity, interpret and communicate safety and efficacy data, and support study enrollment and timelines.
• Marketing and Education: Develop scientifically accurate marketing materials, medical education programs, advisories, and symposia.
• Research and Development Support: Assist in the scientific review, development, approval, execution, and communication of medical affairs sponsored or supported research.
• Cross-Functional Collaboration: Coordinate scientific and medical activities with internal stakeholders, serving as the scientific interface for regulatory discussions.
• Education and Knowledge Sharing: Provide scientific and medical education to investigators, clinical monitors, project team members, and clinicians, staying abreast of therapeutic advancements and medical innovations.
• Compliance and Budget Management: Ensure compliance with regulatory requirements, manage budgets, and adhere to timelines for scientific activities.

Qualifications:

• Medical Degree: Medical Doctorate (M.D.), D.O., or non-US equivalent.
• Experience: Minimum of 2 years in medical affairs, clinical trials, or clinical practice in the pharmaceutical industry or academia, with 3+ years preferred.
• Expertise: Knowledge of clinical trial methodology, data analysis, regulatory requirements, development strategy, and protocol design.
• Leadership: Proven leadership skills in a cross-functional global team environment.
• Communication Skills: Excellent oral and written English communication skills.
• Technical Proficiency: Proficiency in Microsoft Office software.