Associate Director Drug Safety and Medical Monitor

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.

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.
• Demonstrated 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.
• 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.

Supervisory Responsibilities

N/A.

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 other electronic device; and extensive reading.
• The worker is not substantially exposed to adverse environmental conditions.

Compensation

• The expected salary range for fully qualified candidates applying for this role is $157,000 to $186,000.
• This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role.
• This range may be modified in the future.
• An individual’s salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.

Benefits

• Health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits.