Medical Director

• Provide system-level leadership for the Clinical Systems Engineering function
• Establish enterprise strategies, technical standards, priorities, operating models, and performance expectations
• Develop and maintain a Clinical Systems Engineering technical roadmap
• Lead evaluation and planning for medical-device integration, interoperability, middleware, infrastructure, and technical architectures
• Provide leadership and governance for HTM technology integration, data architecture, data stewardship, reporting, and analytics enablement
• Lead and prioritize Clinical Systems Engineering, technology integration, and data personnel
• Provide technical leadership for major enterprise initiatives involving integrated and connected medical technologies
• Partner with Information Services, clinical applications, data governance, Information Security, clinical departments, vendors, and other stakeholders
• Establish operational support and lifecycle-management models for integrated medical-device systems and related technologies
• Develop technical standards for connectivity, interoperability, HTM system integration, and data exchange
• Lead technology evaluation, selection, acquisition, implementation, cybersecurity risk assessment, vulnerability management, and technical risk mitigation
• Provide leadership for healthcare technology data availability and analytics supporting operational and strategic decisions
• Establish documentation, configuration-management, data stewardship, traceability, and performance-measure expectations
• Develop disaster recovery, business continuity, downtime, escalation, and support strategies
• Establish educational and competency programs
• Lead, supervise, mentor, develop, and evaluate assigned personnel
• Develop relationships with manufacturers and technology vendors
• Participate in enterprise architecture, cybersecurity, data governance, clinical technology, and information technology governance
• Provide leadership during significant technology incidents or failures
• Evaluate emerging technologies, standards, industry trends, and best practices

Director, Clinical Systems Engineering

• Establish and lead the global Medical Affairs vision and strategy
• Provide executive leadership for the Medical Affairs organization, including MSLs, Medical Communications, Publications, Medical Education, and Medical Information
• Serve as senior medical leader and strategic advisor to executive leadership and cross-functional partners
• Provide clinical and scientific guidance across Commercial, Market Access, Regulatory Affairs, Research & Development, Manufacturing, Legal, and Corporate Strategy
• Build and oversee relationships with KOLs, clinical investigators, scientific advisors, patient advocacy organizations, and professional societies
• Lead external scientific engagement, medical advisory boards, investigator meetings, medical congresses, scientific exchange, and executive presentations
• Partner with Commercial leadership on compliant medical education, field training, and promotional support materials
• Oversee the Investigator-Sponsored Trial strategy and governance process
• Drive scientific evidence generation and dissemination through publications, congress activities, real-world evidence, and collaborative research
• Ensure Medical Affairs compliance with regulatory requirements, industry standards, and corporate policies
• Recruit, develop, and mentor the Medical Affairs leadership team
• Represent Medical Affairs on the executive leadership team and contribute to corporate strategy, portfolio planning, business development evaluations, and organizational growth

• Serve as clinical science lead and core member of clinical development teams for respiratory studies
• Support day-to-day study execution and alignment with protocols, timelines, and regulatory requirements
• Design and develop clinical trial protocols and associated documents
• Develop clinical components of regulatory documents
• Review and interpret clinical data to ensure data quality, participant safety, and protocol compliance
• Participate in site selection, initiation, and ongoing engagement
• Track study progress, identify risks, and implement mitigation strategies
• Serve as scientific contact for CROs and vendors
• Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams
• Contribute to governance meetings, study updates, data summaries, and risk assessments
• Maintain inspection readiness and support audits and inspections
• Support publications, abstracts, and manuscripts
• Contribute to TPPs, clinical development plans, and risk-benefit assessments
• Support oversight committees for late-stage asthma studies
• Mentor and coach team members where appropriate

Director, Clinical Scientist – Respiratory Indications

• Provide strategic medical leadership for Multiple System Atrophy (MSA)
• Support launch readiness and execution across the U.S. Medical Affairs organization
• Shape and advance U.S. medical strategy using scientific evidence and external stakeholder insights
• Co-create launch strategy with Commercial, Patient Advocacy, Market Access, Regulatory, Clinical Development, Pharmacovigilance, and other stakeholders
• Support launch readiness, lifecycle planning, and integrated evidence generation strategies
• Translate clinical data and scientific insights into stakeholder engagement and brand-planning strategies
• Build and maintain relationships with investigators, KOLs, advocacy leaders, and healthcare professionals
• Represent U.S. Medical Affairs in scientific forums and stakeholder engagements
• Monitor disease-area trends, competitor activities, and policy developments
• Develop and execute an integrated U.S. medical communications strategy
• Co-create the scientific narrative, clinical value story, lexicon, data story, key messages, evidence summaries, and communication themes with Global Medical Affairs
• Own U.S.-specific publication strategy and priorities
• Plan and execute U.S. congress activities, including data rollouts, abstracts, posters, oral presentations, symposia, booths, and communications
• Develop stakeholder mapping and engagement plans
• Oversee U.S. medical materials, slide decks, FAQs, scientific response documents, congress assets, field medical materials, training content, data visualizations, and digital scientific content
• Support Field Medical scientific readiness and training
• Serve as medical reviewer in the promotional review process
• Manage medical writing agencies, publication vendors, freelancers, congress vendors, budgets, timelines, and deliverables
• Drive cross-functional alignment, scientific excellence, external engagement, and execution of the U.S. medical strategy

Medical Affairs Director – Movement Disorders

• Refine and ensure successful implementation of Replimune’s scientific communication platform and medical communication plan
• Develop and review abstracts, publications, congress presentations, monographs, and related content
• Ensure medical and scientific content accuracy and strategic alignment
• Develop, manage, and track scientific communications plans
• Ensure compliance with publication-related policies and procedures
• Remain current on the latest science and data in the field
• Create, collect, and disseminate actionable, business-relevant scientific insights to internal stakeholders and key customer segments
• Support critical product launches
• Develop in-depth therapeutic knowledge of disease, epidemiology, products, and competitor products
• Serve as a resource to stakeholders outside Medical Affairs
• Collaborate closely with members of other internal teams
• Provide information and input for product and competitor insights, medical product plans, deliverables, new business assessments, and other business activities
• Serve as an authoritative source of medical and scientific expertise
• Oversee collection and storage of relevant scientific information, including literature repositories and Replimune data
• Perform other duties as assigned

Director, Medical Publications and Scientific Communication

• Provide clinical development leadership at the study level for one or more clinical-stage assets in early and/or late development
• Foster collaboration with allied functions through communication, collaboration, and coordination
• Mentor and manage one or more clinical scientists as needed
• Contribute to business development and continuous improvement activities
• Contribute to clinical development strategy aligned with enterprise goals and management
• Serve as medical monitor for one or more studies
• Perform ongoing clinical trial data review and cleaning with clinical science and pharmacovigilance
• Attend and contribute to study team meetings
• Present clinical trial findings to management
• Author clinical documents, including protocols and investigator brochures
• Author clinical portions of regulatory documents, including IND, CTA, NDA, and MAA submissions
• Develop and manage relationships with key opinion leaders
• Organize, manage, and lead Steering Committees and contribute to Strategic or Clinical Advisory Boards
• Contribute to manuscripts, publications, and other external-facing documents
• Support Medical Affairs activities as needed
• Participate in or coordinate cross-functional continuous improvement projects
• Act as an internal clinical resource and primary contact for clinical trial staff at study sites on clinical issues, as well as for regulatory, safety, and other functions
• Foster communication and collaboration across functions and between Ono and Deciphera
• Assess new internal or external targets by outlining clinical challenges and opportunities

Medical Director, Clinical Development – Neurology

• Support development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
• Oversee clinical trials at study sites for protocol and GCP adherence
• Review and interpret clinical data to assess investigational drug safety and efficacy
• Author and contribute to clinical and non-clinical development documents, including Clinical Study Protocols, Investigator Brochures, and Clinical Study Reports
• Provide medical expertise on the therapeutic area, disease state, and potential drug effects
• Identify and analyze safety concerns and adverse events and make recommendations
• Stay current with relevant medical literature and clinical trial methodologies
• Contribute medical expertise to external collaborator interactions
• Collaborate with clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical, and project management teams
• Present clinical data to internal and external stakeholders
• Contribute to overall clinical development strategy
• Identify critical clinical development milestones and help drive timelines
• Lead clinical contributions for clinical study reports, clinical documents, and regulatory submissions
• May oversee Clinical Scientists working on the same or other programs

Medical Director – Clinical Development

• Develop and lead product safety surveillance strategies
• Identify emerging clinical safety issues and recommend risk-mitigation measures
• Conduct or oversee routine and ad hoc safety-data reviews and monitor safety signals
• Lead aggregate safety reviews and chair internal safety governance committees
• Plan, interpret, prepare, and present safety-data analyses and summaries
• Build relationships with clinical study teams, safety vendors, and business partners
• Oversee expedited safety reporting, including medical review of ICSRs, SUSARs, and other reportable safety events
• Ensure medical follow-up and consistent assessment of individual safety cases
• Review clinical-trial safety data and provide medical safety guidance
• Lead aggregate reporting and prepare regulatory documents, including Investigator's Brochures, DSURs, and Risk Management Plans
• Provide safety input into clinical development plans, protocols, consent forms, case report forms, statistical analysis plans, data-monitoring plans, and clinical study reports
• Represent Pharmacovigilance in meetings with the FDA and other global regulatory authorities
• Maintain compliance with global pharmacovigilance regulations, SOPs, and internal guidelines
• Build and improve Oruka’s pharmacovigilance system and infrastructure
• Oversee vendors supporting case processing, safety-database management, aggregate reporting, and literature surveillance
• Monitor vendor quality and performance and resolve issues
• Provide safety leadership for independent data monitoring and adjudication committees
• Support inspection readiness and represent Pharmacovigilance during inspections, audits, and due-diligence activities

Senior Medical Director, Pharmacovigilance and Safety

• Manage all Catholic Charities behavioral health services, including day-to-day operations of the outpatient clinic in Salem, Massachusetts
• Implement and manage behavioral health contracts with the Department of Children and Families and other funding agencies
• Hire, supervise, and terminate clinic program staff
• Directly supervise clinic psychiatrists and clinicians
• Conduct clinical team meetings, case conferences, safety and quality assurance meetings, and in-service trainings
• Provide performance feedback and corrective action for program staff and interns
• Conduct annual performance appraisals for direct reports
• Lead community outreach, identify referral sources, and generate referrals
• Direct and supervise clinical intake operations
• Ensure clinical documentation meets regulatory standards
• Provide direction, training, and coaching to program staff and interns on DPH, BSAS, and DCF requirements
• Maintain relevant agency licenses and the outpatient clinic policies and procedures manual
• Complete insurance credentialing and ensure compliance with third-party payer requirements
• Coordinate client care with the agency staff psychiatrist and other staff
• Participate in monthly High-Risk Review meetings
• Facilitate biannual Quality Assurance Committee meetings
• Respond to client grievances, complaints, and on-call emergencies
• Mediate clinician/client conflicts and manage day-to-day client needs
• Monitor state and legislative rules affecting clinical services
• Review financial statements and clinic budgets with business and finance leadership
• Contribute to grant writing and serve on agency committees
• Identify new opportunities and market programs to the community
• Work in an office and residential building with employees and clients; perform work remotely as needed
• Attend internal and external meetings and trainings
• Travel locally

Director of Clinical Services

• Provide clinical leadership, guidance, and supervision to mental health clinicians and peer support specialists
• Oversee day-to-day operations of the Catholic Charities Behavioral Health Clinic in Boston
• Hire, train, supervise, and schedule staff clinicians and peer support specialists
• Review assessments, treatment plans, progress notes, and clinical documentation for quality and compliance
• Collaborate with the Department of Children and Families and other external funding agencies
• Oversee and manage contracts with DCF and other agencies
• Establish and maintain community partnerships to secure referrals
• Participate in multidisciplinary team meetings, case conferences, High Risk meetings, Quality Assurance meetings, and peer supervision sessions
• Provide individual supervision to staff at least monthly, often weekly
• Meet with the program team regarding clinical and case management needs and provide organizational updates
• Provide direct services to a small caseload of clients or families as needed
• Collaborate with the Director of Clinical Services and Senior Director for Family Services on budgets and contractual obligations
• Monitor employee performance, provide feedback, and complete annual performance appraisals
• Perform on-call clinician responsibilities as needed
• Prepare and submit timely reports to funding agencies
• Review and approve employee timecards
• Work in office and community settings, attend meetings and trainings, and travel locally as needed
• Maintain HIPAA confidentiality and professional boundaries

Medical Director jobs in Massachusetts

Director, Clinical Systems Engineering