Medical Director, Clinical Safety And Development

Job Title: Medical Director, Clinical Safety and Development The Medical Director, Clinical Safety and Development is a strategic physician leader responsible for integrating clinical safety strategy, risk management, and safety governance across the development portfolio as it advances toward regulatory approval and commercialization. This role provides program-level oversight of benefitrisk assessment, medical monitoring, and safety surveillance, while contributing to overall clinical development strategy. As the organization prepares for commercialization, the Medical Director plays a key role in building safety infrastructure, pharmacovigilance capabilities, and governance processes to support product approval and post-marketing commitments, collaborating closely with Clinical Operations, Regulatory Affairs, pharmacovigilance partners, Biostatistics, Medical Affairs, Quality, and Executive Leadership to ensure high standards of patient safety and regulatory compliance. Responsibilities Serve as the medical safety lead for assigned development programs, providing sponsor medical review and approval of safety cases and follow-up within established timelines. Provide ongoing assessment of product safety profiles throughout clinical development. Lead safety signal detection, evaluation, and escalation activities to ensure emerging risks are identified and managed appropriately. Drive continuous improvement initiatives across clinical safety, pharmacovigilance, quality, and regulatory compliance functions. Lead preparation and medical review of sponsor safety materials for DSMB/SMC meetings, present safety assessments as appropriate, and coordinate follow-up actions while maintaining required blinding and committee independence. Ensure timely identification and clear communication of emerging safety risks to internal and external stakeholders. Provide medical monitoring support for clinical studies, ensuring appropriate oversight of subject safety and study conduct. Lead medical review of adverse events, medical history, and concomitant medication coding, collaborating closely with Data Management to ensure data integrity and timely reconciliation across clinical and safety systems. Collaborate with investigators regarding subject safety, protocol adherence, and overall study conduct. Provide medical safety input into clinical protocols, amendments, informed consent forms, and investigator guidance, including safety monitoring plans, infusion reaction management, dose interruption or discontinuation criteria, and risk mitigation strategies. Contribute to clinical development plans and overall program strategy, ensuring safety considerations are integrated into key decisions. Support interpretation of clinical data and contribute to the development of regulatory and scientific documents. Author and review safety sections of regulatory submissions, ensuring accuracy and consistency with the overall safety profile. Serve as a senior leader responsible for key safety-related documents, including IND safety reports, annual reports, Development Safety Update Reports (DSURs), Investigator Brochures, Clinical Study Reports, NDA/BLA submission packages, Risk Management Plans (RMPs), safety narratives, and aggregate analyses. Support interactions with FDA, EMA, and other global health authorities on safety-related matters. Lead governance and oversight of safety operations vendors, ensuring robust performance management, clear accountability frameworks, effective issue escalation processes, and adequate backup coverage for adverse event intake and case processing while maintaining regulatory compliance and inspection readiness. Contribute to product labeling discussions and safety-related regulatory strategy. Partner with Medical Affairs to support safety communications and scientific exchange with external stakeholders. Support planning for post-marketing safety commitments and lifecycle management activities. Assist in building safety governance and oversight processes for approved products. Provide medical and business input into safety database workflows, access and blinding controls, validation and user acceptance testing, and change control, in partnership with system owners and Quality. Develop and maintain applicable safety standard operating procedures (SOPs), work instructions, and Safety Management Plans. Lead clinical safety compliance and inspection readiness activities, overseeing review and approval documentation, supporting health authority and internal audits, and ensuring timely follow-up, risk mitigation, and resolution of findings in collaboration with Quality and vendor partners. Drive continuous improvement in safety surveillance and safety-related decision-making processes. Essential Skills MD or DO degree required; board certification preferred. Minimum of one (1) year of direct patient care or clinical practice experience. Minimum of 3 to 5 years of clinical development, medical monitoring, drug safety, or pharmaceutical industry experience for Medical Director level, or 6+ years for senior Medical Director level. Significant experience supporting clinical development programs in biotechnology or pharmaceutical companies. Experience interpreting adverse event data and conducting benefitrisk evaluations. Working knowledge of ICH guidelines and Good Clinical Practice (GCP) requirements. Working knowledge of pharmacovigilance regulations and clinical trial safety oversight. Working knowledge of FDA and global regulatory requirements relevant to clinical safety and development. Experience contributing to IND, NDA, BLA, MAA, or equivalent regulatory submissions. Strong scientific, analytical, and medical judgment skills. Excellent written and verbal communication abilities. Demonstrated expertise in clinical safety, drug safety, pharmacovigilance, regulatory compliance, medical monitoring, medical review, and product labeling. Additional Skills & Qualifications Experience in late-stage clinical development and registration-enabling studies. Prior responsibility for safety leadership across one or more development programs. Experience interacting directly with regulatory agencies on safety matters. Experience supporting products approaching approval or commercialization. Background and experience in immunology, autoimmune disease, neuromuscular disease, cell and gene therapy, or other specialty therapeutic areas strongly preferred. Experience participating in Data Monitoring Committees (DMCs) or Safety Review Committees. Prior people management experience.Understanding of post-marketing safety surveillance and pharmacovigilance operations. Interest in helping build and shape the safety function and influence development strategy as the organization transitions toward approval and commercialization. Job Type & Location This is a Permanent position based out of Gaithersburg, MD. Pay and Benefits The pay range for this position is $275000.00 - $350000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Company BenefitsCompany BenefitsCompany Benefits Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Oct 9, 2026. 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law. If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on click.appcast.io for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr Actalent