Job Title: Director, Clinical SafetyJob Description The Director, Clinical Safety will be responsible for leading overall product safety strategy, safety surveillance, and risk management. This role involves providing safety leadership across clinical studies, post-marketing surveillance, signal detection, and regulatory submissions. The Director will ensure proactive safety monitoring through the Safety Management Team framework and collaborate effectively with various departments to manage benefit-risk throughout the drug lifecycle. Responsibilities + Lead and medically-scientifically direct a team of junior physicians and scientists responsible for compound/product safety, including project-specific training and coaching. + Represent the Clinical Safety and Pharmacovigilance (CSPV) on the Global Product Team or specific sub-teams, providing safety leadership and serving as the primary point of contact. + Review and analyze data from clinical trials, post-marketing, and other relevant sources for prompt identification of safety signals. + Review and evaluate serious adverse event reports from clinical trials or post-marketing for completeness, accuracy, expectedness, and relatedness. + Lead internal and external interactions, especially regulatory and expert advisory, to ensure quality outcomes in risk evaluation and management. + Define and implement strategies and action plans for identifying and managing risks throughout the product lifecycle. + Coordinate and manage resources to develop and deliver high-quality safety evaluation-related documents and deliverables on time. + Participate actively in safety-related regulatory interactions, such as regulatory meetings and post-approval commitments. Essential Skills + Strong leadership and communication skills. + Experience in safety surveillance and clinical development. + MD Board certification. + Professional degree (J.D., M.D., or Pharm. D.). + 4 or more years of experience in the pharmaceutical industry, regulatory agency, or academia. + Exposure to drug development, clinical pharmacology, and/or epidemiology. Additional Skills & Qualifications + Experience in regulatory submissions and interactions. + Strong analytical and problem-solving skills. + Ability to work effectively in cross-functional teams. Work Environment Prefer a local or remote-based candidate who can come into the office when needed, approximately once a quarter. Pay and Benefits The pay range for this position is $110.00 - $130.00 Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position will be accepting applications until Dec 19, 2024. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.