Medical Director

• Assist with development of service criteria and standards of care
• Recommend application of medical necessity criteria for service eligibility, including type, amount, and duration
• Help develop processes to assess and document medical necessity
• Assist with development and implementation of the utilization management plan
• Review approval and denial of service requests and care; ensure protocols and audits are completed by appropriately credentialed staff
• Assist with Utilization Management, Quality Management, Care Management, peer reviews, appeals, and reconsiderations
• Review and evaluate treatment procedures and outcomes of psychiatrists and other medical professionals
• Analyze and evaluate patient data and test findings to diagnose mental disorders
• Review consumer information and records, including social and medical history
• Collaborate with physicians, psychologists, pharmacists, social workers, psychiatric nurses, and other professionals on treatment plans and progress
• Provide consultation, training, and education to staff and community partners
• May supervise members of the Medical Management team
• Partner with Human Resources and the Medical Team to attract, maintain, and retain qualified staff
• Ensure staff training, policy compliance, workflow organization, adequate resources, and regulatory compliance
• Promote a positive, diverse, and inclusive working environment
• Resolve conflicts, set performance goals, provide feedback, coaching, and mentoring
• Encourage cross-team collaboration and partnership

Medical Director – Physical Health

• Provide medical oversight of clinical trials to ensure SOPs, client directives, good clinical practice, and regulatory requirements are followed
• Manage and oversee contracted services
• Attend and present at investigator and sponsor meetings
• Provide medical consultation to clients, investigators, project team members, and internal team members
• Support business development activities
• Provide medical review and analysis of clinical trial serious adverse events
• Ensure tasks delegated to medical monitors are properly executed
• Monitor adverse events, laboratory abnormalities, patient medical status, concomitant medications, and un-blinding requests
• Discuss medical concerns with principal investigators and clients and apply medical judgment to clinical situations
• Medically review adverse events of special interest, serious adverse events, and clinical outcome events
• Perform data review and validation, including coding listings and safety data, to identify potential safety concerns
• Provide therapeutic and protocol training
• Write or review CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules
• Manage signal detection activities and scientifically review aggregate reports
• Contribute to label updates, dossier maintenance, and risk management activities
• Medically review adverse-event and serious-adverse-event data from solicited, spontaneous, and literature sources

Medical Director/Senior Medical Director – Endocrinology

• Provide medical oversight of clinical trials to ensure SOPs, client directives, good clinical practice, and regulatory requirements are followed
• Manage and oversee contracted services
• Attend and present at investigator and sponsor meetings
• Provide medical consultation to clients, investigators, project teams, and associates
• Support business development activities
• Provide medical review and analysis of clinical trial serious adverse events
• Ensure delegated medical-monitor tasks are properly executed
• Provide therapeutic and protocol training
• Write and/or review CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules
• Monitor safety variables including adverse events, laboratory abnormalities, patient medical-status changes, concomitant medications, and unblinding requests
• Discuss medical concerns with principal investigators and clients and interpret inclusion/exclusion criteria
• Review adverse events of special interest, serious adverse events, and clinical outcome events
• Perform data review and validation, including coding listings and full safety data review
• Manage signal detection activities and review aggregate reports for marketed products
• Contribute to label updates, dossier maintenance, and risk-management activities
• Medically review adverse-event and serious-adverse-event data from solicited, spontaneous, and literature sources

• Participate in the development, implementation, and evaluation of clinical and medical programs
• Expand Aetna medical management programs to address member needs across the continuum of care
• Support Medical Management staff by ensuring timely and consistent responses to members and providers
• Conduct or support prior authorization, pre-certification, concurrent reviews, peer-to-peer calls, first-level appeals, special projects, and committee participation as needed
• Provide clinical expertise and business direction through participation in clinical team activities
• Act as lead business and clinical liaison to network providers and facilities
• Support effective execution of medical services programs by clinical teams

Medical Director – Commercial

• Lead development and delivery of the global medical affairs plan and integrated evidence plan for oncology assets
• Drive above-country medical activities, including advisory boards, congress strategy, symposia, and scientific education
• Own scientific engagement with external experts, patients, payers, and regulators
• Partner with research and development to design and prioritize global and supportive clinical studies
• Review investigator-initiated proposals
• Support brand and launch planning by providing medical input to local operating companies and commercial teams
• Provide medical governance and review scientific materials for accuracy, compliance, and clear communication
• Shape evidence generation and translate clinical insights into patient impact

Global Medical Director, Oncology

• Contribute to development of the US Medical Affairs Plan and lead execution of assigned medical strategies and tactics, including launch-readiness activities
• Ensure execution of medical tactics with the cross-functional Medical Matrix Team, including omnichannel activities, congresses, and medical education
• Develop and execute advice-seeking activities such as advisory boards and scientific round tables
• Collaborate with cross-functional partners to share external insights internally and inform medical strategy and clinical development
• Integrate US environment needs and medical voice of the customer into medical plans and global medical work
• Identify and prioritize evidence gaps and provide US Medical input into clinical studies, real-world evidence initiatives, and other evidence-generation activities
• Partner with Medical Communications, Training, and Medical Information on medical material development and communication plans
• Assist with development of internal medical resources, including FAQs, Treatment Landscape, and MSL materials
• Serve as a Subject Matter Expert supporting scientific training plans for SCLC and NSCLC lung cancer
• Prioritize medical activity investment using GSK’s Medical Impact Framework
• Lead or contribute to scientific engagement with external experts and communities
• Apply medical governance in alignment with GSK policies and procedures
• Support the US Medical Affairs Lead as needed
• Collaborate with Global Medical, Field Medical, Clinical Development, Commercial, and other internal teams to deliver assigned medical activities

Medical Director – Lung

• Drive growth in McMillan Pazdan Smith’s Healthcare practice
• Lead pursuit strategy and execution across all locations for the Healthcare practice
• Develop and document win strategies for priority pursuits, including win themes, message hierarchy, differentiators, proof points, and narrative arcs across RFQ, RFP, and interviews
• Assemble and direct Healthcare pursuit teams, run strategy sessions, set schedules, assign ownership, and drive decisions
• Make decisions on pursuit content, structure, and emphasis; resolve competing input
• Direct the graphic approach for priority pursuits and direct designers
• Lead interview preparation with the Healthcare BD leader, including presentations, message discipline, team composition, coaching, rehearsals, and Q&A anticipation
• Run win/loss debriefs and feed findings into practice strategy and positioning
• Lead healthcare marketers producing practice pursuits; set priorities, balance workload, and mentor staff
• Own QA/QC for healthcare pursuit deliverables
• Establish and maintain pursuit standards, playbooks, and templates; drive continuous improvement
• Develop team capability in strategic writing and narrative construction
• Track and report pursuit metrics, including shortlist rate, interview-to-win conversion, and win rate
• Partner with practice and BD leadership on go/no-go discipline and bid criteria
• Analyze losses and translate findings into positioning, teaming, and process changes
• Support healthcare strategic planning and market analysis
• Drive Healthcare brand strategy across sectors and markets
• Maintain knowledge of healthcare market trends and client priorities
• Ensure competitor profiles are maintained and brief leadership on market conditions and positioning
• Support client feedback initiatives, surveys, and debriefs
• Ensure project profiles, staff resumes, and reference data are current and pursuit ready
• Develop outcome-focused case studies and close gaps in the proof library
• Provide Healthcare market input to marketing communications on PR, social, thought leadership, and collateral
• Collaborate on photography priorities, project storytelling, and award submissions
• Partner with business development on client capture planning and prepositioning
• Perform other related duties as assigned

Practice Marketing Director – Healthcare

• Lead delivery of high-quality data from multiple sources while supporting global development programs for one or more product candidates across all study phases
• Lead development program design, conduct, oversight, protocol design, execution, analysis, and reporting
• Lead program- and compound-level development activities and multidisciplinary clinical development teams
• Contribute to clinical strategy discussions and create and review clinical documents supporting regulatory submissions
• Represent Clinical Development Sciences in integrated development teams to uphold scientific, ethical, and regulatory standards and support worldwide registration submissions
• Lead multidisciplinary clinical development teams, including proactive risk identification and management, consistency, data quality, and scientific validity
• Review medical and scientific elements of protocols, IBs, IND, MAA/NDA modules, PIP/PPSR documents, and clinical study reports
• Serve as subject matter expert for assigned clinical development programs and lead trial/program design, data collection tools, data review, and data analysis
• Provide input and oversight for critical study documentation, including statistical analysis plans
• Support optimal study execution and data collection with clinical operations, data management, and statistics
• Train CRAs; select laboratory assessments for safety and pharmacodynamics; and provide input into tables, listings, and figures
• Serve as SME for global marketing-application regulatory questions and support responses to CTA questions outside the US
• Collaborate with study teams, data management, biostatistics, regulatory, and other functional peers
• Support external dissemination of clinical-trial data through publication committees, abstracts, posters, and manuscripts
• Present to and interact with investigators and thought leaders; conduct or oversee scientific training, investigator meetings, study-data sessions, and advisory boards
• Provide leadership and oversight to clinical development staff and study-level scientists
• Set goals and evaluate performance for direct reports; support career-path clarity, training plans, and leadership development
• Perform other duties as assigned

Medical Director jobs in North Carolina

Medical Director – Physical Health

Medical Director/Senior Medical Director – Endocrinology

Medical Director/Senior Medical Director – Endocrinology

Medical Director – Commercial

Global Medical Director, Oncology

Medical Director – Lung

Practice Marketing Director – Healthcare

Director, Clinical Development Sciences