Associate Director Drug Safety and Medical Monitor

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.

Job Summary:  

The Associate Director, Drug Safety and Medical Monitoring is responsible for leading medical monitoring and medical review activities across all clinical trials, as well as overseeing patient safety surveillance and signal detection throughout clinical development programs. The individual collaborates closely with cross-functional teams, including Clinical Development, Clinical Operations, Biometrics, Regulatory, and Pharmacovigilance, to identify and resolve safety-related issues, ensure high-quality data handling, and support regulatory compliance. The role also contributes to the authoring and review of key regulatory and safety documents, including Clinical Tial Protocols (CTP), Informed Consent Forms (ICF), Investigator’s Brochures (IB), Clinical Study Reports (CSR), DSURs/PSURs/PBRERs, and other regulatory submissions.

Essential Duties & Responsibilities:

• Lead medical monitoring and medical review and coding review activities across all clinical trials, ensuring high-quality safety oversight and compliance with regulatory standards.
• Perform comprehensive and timely evaluations of safety data, including medical and coding review, CRFs, TFLs, and adverse events/serious adverse events/adverse events of special interest.  
• Author and contribute to key regulatory and safety documents, including CTP, ICF, IB, CSR, and publications.
• Prepare and review DSURs/PSURs/PBRERs for regulatory submissions in collaboration with Regulatory Affairs and cross-functional teams.
• Review safety data outputs/TFLs for accuracy, completeness, and consistency prior to internal and external submissions; collaborate closely with Clinical, Regulatory, Biometrics, and Pharmacovigilance teams to ensure integrated safety evaluation.
• Serve as a key point of contact for contract medical monitoring vendors (e.g., medical monitoring, medical review, 24/7 call centers) to address and resolve medical monitoring-related inquiries and questions from the sites/CRA/study team.
• Develop, implement, and update SOPs and procedure manuals to enhance medical monitoring processes to ensure safety oversight and regulatory compliance.
• Support signal detection activities and provide medical input on safety trends and risk evaluation for both investigational and commercial products.
• Manage and mentor drug safety and medical monitoring teams, fostering high-performance and compliance-driven culture.
• Maintain deep therapeutic area knowledge to support clinical development and safety decision-making, maintain up-to-date knowledge of FDA and global regulations and industry best practices.

Supervisory Responsibilities:

• N/A.

Knowledge & Other Qualifications:

• Degree in a medical field, MD, DO, MBBS, Nurse Practitioner, or equivalent is required with a minimum of five years of relevant experience.
• Knowledge of medical and therapeutic terminology.
• Working knowledge of ICH guidelines and other worldwide safety regulations.
• Demonstrated working knowledge of FDA regulations relevant to Patient Safety and adverse event reporting, including periodic safety reporting.
• Working knowledge of the MedDRA and WhoDrug dictionaries.

Other Characteristics:

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability to have an innovative and dynamic approach to work.
• A self-starter able to work independently but comfortable working in a team environment.
• Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
• Capable of performing other duties as assigned by Management.
• Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel Requirements:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
• The worker is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or