Medical Director, Clinical Safety And Development

Job Title: Medical Director, Clinical Safety and Development Job Description
The Medical Director, Clinical Safety & 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 the overall clinical development strategy. As the organization moves toward commercialization, the Medical Director plays a key role in establishing the safety infrastructure, pharmacovigilance capabilities, and governance processes required to support product approval and postmarketing commitments. The Medical Director collaborates closely with Clinical Operations, Regulatory Affairs, pharmacovigilance partners, Biostatistics, Medical Affairs, Quality, and Executive Leadership to drive informed decisionmaking and ensure the highest 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 associated followup within established timelines.
- Provide ongoing assessment of product safety profiles throughout clinical development.
- Lead safety signal detection, evaluation, and escalation activities to ensure timely risk identification and management.
- 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 followup actions while maintaining required blinding and committee independence.
- Ensure timely identification and communication of emerging safety risks to internal stakeholders and partners.
- Provide medical monitoring support for clinical studies, including realtime evaluation 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 clinical investigators regarding subject safety, protocol adherence, and study conduct.
- Provide medical safety input into protocols, amendments, informed consent forms, and investigator guidance documents, including safety monitoring plans, infusion reaction management, dose interruption and discontinuation criteria, and risk mitigation strategies.
- Contribute to clinical development plans and overall program strategy from a safety and benefitrisk perspective.
- Support interpretation of clinical data and contribute to the development of regulatory and scientific documents.
- Author and review safety sections of regulatory submissions to ensure clarity, accuracy, and regulatory compliance.
- Serve as the senior leader responsible for key safety deliverables, 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 safety analyses.
- Support interactions with FDA, EMA, and other global health authorities on safety and risk management topics.
- 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 safetyrelated regulatory strategy, including benefitrisk communication.
- Partner with Medical Affairs regarding safety communications, scientific exchange, and external engagement on safety topics.
- Support planning for postmarketing safety commitments and lifecycle management activities for approved products.
- Assist in building safety governance and oversight processes for approved products, including safety committees and decisionmaking frameworks.
- 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 safety standard operating procedures (SOPs), work instructions, and Safety Management Plans to support consistent, compliant operations.
- Lead clinical safety compliance and inspection readiness activities, overseeing review and approval documentation, supporting health authority and internal audits, and ensuring timely followup, risk mitigation, and resolution of findings in collaboration with Quality and vendor partners.
- Drive continuous improvement in safety surveillance and benefitrisk decisionmaking processes across programs.
Essential Skills
- MD or DO degree is required; board certification is preferred.
- Minimum of one (1) year of direct patient care or clinical practice experience.
- Minimum of 35 years of clinical development, medical monitoring, drug safety, or pharmaceutical industry experience for the Medical Director level, or 6+ years for the senior Medical Director level.
- Significant experience supporting clinical development programs in biotechnology or pharmaceutical companies.
- Experience interpreting adverse event data and conducting formal benefitrisk evaluations.
- Working knowledge of ICH guidelines and Good Clinical Practice (GCP) requirements.
- Working knowledge of pharmacovigilance regulations and global safety reporting requirements.
- Working knowledge of FDA and global regulatory requirements related to clinical trial safety oversight.
- Experience contributing to IND, NDA, BLA, MAA, or equivalent regulatory submissions.
- Strong scientific, analytical, and medical judgment skills applied to complex safety and efficacy data.
- Excellent written and verbal communication abilities, including preparation of safety documents and presentations.
- Demonstrated capability in clinical safety, drug safety, pharmacovigilance, regulatory compliance, medical monitoring, medical review, and product labeling.
- Background or strong familiarity with immunology, autoimmune disease, neuromuscular disease, or cell and gene therapy therapeutic areas.
Additional Skills & Qualifications
- Experience in latestage clinical development and registrationenabling 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 is strongly preferred.
- Experience participating in Data Monitoring Committees (DMCs) or Safety Review Committees.
- Prior people management experience overseeing medical or safety teams.
- Understanding of postmarketing safety surveillance and pharmacovigilance operations.
- Interest in helping build and shape the safety function and influence development strategy as the company transitions toward approval and commercialization.
Work Environment
This is a remote position that offers the opportunity to work collaboratively with a crossfunctional clinical development organization. The Medical Director reports to the Vice President of Clinical Development and works alongside another Medical Director within a highly engaged, developmentfocused environment. The role involves close interaction with Clinical Operations, Regulatory Affairs, Biostatistics, Medical Affairs, Quality, and external pharmacovigilance vendors, using modern clinical and safety technologies and systems to support global development programs. The work setting emphasizes collaboration, scientific rigor, and proactive safety governance as the organization advances programs toward regulatory 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 Benefits
Company Benefits
Company Benefits
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Oct 5, 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.

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