Medical Director

• Oversee a team of several medical writers within assigned therapeutic areas and client accounts
• Review and revise all medical content to ensure strategic integrity, scientific accuracy, and quality execution of deliverables
• Counsel clients in the development of various medical strategies and medical communication tactics
• Drive contributions to strategic planning initiatives and tactical ideation
• Ensure all deliverables meet the highest standards of scientific accuracy, consistency, and compliance
• Understand project scopes and statuses and partner with project leads
• Support senior medical and operations leaders by providing input into staffing needs
• Contribute to business growth by identifying organic growth opportunities

• Lead safety strategy and key messaging in NDA/BLA/MAA submissions
• Lead ongoing safety monitoring of assigned investigational and marketed products
• Providing PVRM Medical representation on product specific and/or clinical study team meetings and governance committees
• Prepare and present safety data analysis to project teams and senior management, for assigned products
• Evaluate safety data and contribute/author safety sections as a medical safety subject matter expert (SME) on behalf of PVRM for: Study Protocols, Informed Consent Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), and Investigator’s Brochures (IB)
• Contribute to preparation and update of Company Core Data Sheets (CCDS), Locally labels such as, United States Prescribing Information (USPI), European Summary of Product Characteristics (SmPC), Canadian Product Monograph (PM), and Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategy (REMS)
• Medical review of Aggregate Reports (PADER, PSUR, PBRER, DSUR, IND/NDA Annual Reports)
• Handle Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries
• Perform aggregate safety data review in support of signal and trend detection activities, safety evaluation/analysis/investigation, risk benefit management and other departmental activities as appropriate
• Participate/contribute to other activities such as literature evaluation, investigator site training, continuing education for internal staff, audits, and inspections
• Develop and maintain strong relationship with cross-functional teams such as Clinical Development, pre-clinical Safety, Clinical Operations and Clinical Pharmacology
• Maintain a working knowledge of applicable global regulatory authority regulations
• Support PVRM or cross-functional ad-hoc projects or assignments that require safety input
• Ensure compliance with regulations/internal SOPs and fosters a culture of “Patient first” in line with SMPA’s values and related behaviors
• Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, adverse event coding, concomitant medication coding, and causality statements

Senior Medical Director, PVRM

• Carry a clinical caseload of up to 50% (adjusted as administrative responsibilities evolve), providing psychiatric diagnostic evaluations and ongoing medication management to pediatric patients across multiple states.
• Own the psychiatry service line end-to-end: clinical quality, provider performance, care protocols, and alignment with Brightline's evidence-based care standards.
• Collaborate closely with peer service line owners in therapy, psychological testing, and coaching to ensure coordinated, multidisciplinary care delivery.
• Sign and maintain Collaborative Practice Agreements (CPAs) with nurse practitioners; partner with the CMO, Legal, and Compliance on the strategic framework governing CPAs across jurisdictions.
• Document work meticulously, including session notes, care plans, and progress in the electronic health record.
• Directly supervise and manage a psychiatry team composed primarily of nurse practitioners, as well as a pediatrician, with potential growth to include additional psychiatrists.
• Exercise hiring and personnel decision authority in collaboration with the CMO, including recruitment, onboarding, performance management, and when necessary, offboarding.
• Approve timecards and manage scheduling for part-time direct reports.
• Conduct regular 1:1s, case reviews, and clinical office hours to support the professional growth, clinical development, and accountability of team members.
• Foster a culture of psychological safety, high standards, and continuous learning within the psychiatry department.
• Develop and maintain clinical protocols, treatment pathways, and quality assurance processes for the psychiatry service line.
• Lead chart reviews and ongoing quality monitoring to ensure adherence to evidence-based care and Brightline's clinical standards.
• Identify and escalate systemic clinical risks, regulatory issues, and practice gaps, partnering with the CMO and Compliance to address them proactively.
• Contribute to organizational policies and procedures as they relate to psychiatry, controlled substance prescribing, and multi-state telehealth compliance.
• Co-manage the psychiatry department budget in collaboration with the CMO, providing input on resource allocation, staffing needs, and operational priorities.
• Monitor productivity and care delivery metrics to support service line efficiency and sustainability.
• Partner with Care Operations to optimize workflows, reduce clinician burden, and ensure smooth day-to-day function of the psychiatry team.
• Effectively utilize AI tools to enhance clinical workflows, documentation quality, and care delivery within the psychiatry service line and in multidisciplinary collaboration.
• Partner with Product and Engineering to provide clinical input on technology builds, including documentation tools, decision support features, and patient-facing enhancements.
• Actively engage with emerging telehealth technologies and help evaluate new tools for safety, efficacy, and clinical fit.
• Contribute clinical perspective to Brightline's broader AI strategy, owned by the CMO and executive leadership team.

Medical Director, Child and Adolescent Psychiatrist

• Lead the project scientists ensuring appropriate training, mentoring, and supervision
• Work closely with functional partners to ensure integrated and strategic approach
• Provide support for clinical studies including medical monitoring and response to site issues
• Co-lead and oversee clinical development and regulatory submission documents
• Collaborate with clinical leaders and project scientists on key design elements
• Address protocol questions from Health Authorities and Ethics Committees
• Track study recruitment and implement action plans when necessary

Medical Director/Senior Medical Director - Study Responsible Physician, Oncology Late Development

• Leads the project scientists, ensuring appropriate training, mentoring, and supervision across the assigned study/studies within the clinical development program
• Works closely with functional partners (Data Management, Biostatistics, Regulatory, GCO, QMMC, GMS) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in late development in close collaboration with key functional stakeholders
• Provides support for clinical study/studies within a development program including: Working closely with clinical project scientists in collaboration with GCO and GMS to ensure comprehensive medical monitoring, thorough and timely responses to address site issues and eligibility questions, and detailed, real time review of serious adverse events and deaths
• Working in partnership with clinical project scientists to ensure development of high quality study protocols including use of consistent processes/standards across studies
• Collaborating with the Clinical Leader, Clinical Project Scientists and Procurement on key study design elements including assessment of complexity and cost of protocol-required evaluations
• Participating in strategic study start-up planning in collaboration with GCO and C&G including early site assessment, feasibility, and use of simplified contract and budget templates to accelerate rate of site activations
• Co-leading and overseeing clinical development/authorship of informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents
• Working closely with Medical Writing to support protocol or protocol amendment completion
• Working closely with Clinical Leader, Regulatory and GCO to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion
• Working closely with GCO to track study recruitment and implement action plans to address early impediments to study enrollment
• Working closely with Quality Management & Quality Assurance to review audit findings and implement effective corrective action plans
• Working closely with clinical scientists and data management to support medical review and data query resolution
• Interacting with clinical investigators and Key Opinion Leaders as appropriate
• Working with GCO to provide oversight of CRO/study vendors’ performance as it relates to study start-up and conduct
• Working with the Clinical Leader, with Data Management and with Statistics on analysis of study results and completion of study reports
• Works with the Clinical Leader to support the development and compilation of NDA/MAAs and to support responses to Health Agency questions and HA presentations post-filing
• May review/co-author medical publications emerging from clinical trial results
• May interact with medical consultants in concert with senior clinical staff, in conducting IDMC and Investigator meetings as well as Advisory Boards

Medical Director/Senior Medical Director, Oncology Late Development

• Lead, supervise, and support provider teams, ensuring clinical quality and regulatory compliance.
• Manage hiring, training, coaching, and performance evaluation for direct reports.
• Strategically deploy clinical resources using data-driven KPIs to achieve market and organizational goals.
• Develop and nurture partnerships with local clinical communities, health plans, and other key stakeholders.
• Champion our value-based, patient-centered care model for the frailest and most vulnerable populations.
• Deliver clinical oversight for patient care, including annual wellness visits, urgent care, care transitions, and continuity care.
• Participate in care team huddles, providing expert clinical guidance to drive better outcomes and overall performance improvements.
• Ensure compliance with all medical and operational policies, protocols, and guidelines.
• Support direct patient care and on-call activities as needed.

Market Medical Director

• Define and execute the development strategy of oncology program(s)
• Lead one or more subteams in clinical development
• Serve as the clinical lead across multiple clinical trials
• Provide oversight and management responsibilities of medical directors
• Accountable for clinical development strategy, trial design, execution, and results delivery
• Oversee the development and management of clinical protocols and amendments
• Lead peer-to-peer interactions with investigators
• Collaborate with Clinical Scientist to review and interpret clinical data.

Clinical Development Executive, Medical Director – GI Oncology

• Responsible for assisting the Medical Director in the oversight of Utilization Management (UM) programs
• Support the development and maintenance of these programs, focusing on clinical accuracy and appropriateness
• Assist the Medical Director in developing strategic corporate direction for UM programs
• Support the SVP, Healthcare Services in preparing annual metrics of results for UM programs
• Contribute to measurable outcomes for prior authorization, step therapy, and quantity limit programs
• Collaborate with internal teams to support corporate HEDIS initiatives with appropriate clinical program development
• Work closely with clinical program development teams, clinical service operations, and clinical quality committees
• Provide clinical guidance and oversight to these areas
• Serve on IH committees as directed by the Medical Director

Associate Medical Director – UM PT

• Drive quality medicine and patient safety across hospitals
• Ensure consistent delivery of high-quality, evidence-based care
• Coach and develop Medical Directors through record reviews and real-time feedback
• Champion patient safety initiatives, including event reporting and improvement efforts
• Support adoption of new medical advancements and standards of care
• Oversee medical record quality, equipment standards, and clinical compliance
• Manage medical-related client concerns and board complaints
• Foster a culture of collaboration, accountability, and safety within the team
• Mentor and grow Medical Directors and veterinarians

Group Medical Director

• Drive Quality Medicine & Patient Safety
• Ensure consistent delivery of high-quality, evidence-based care across hospitals
• Coach and develop Medical Directors through record reviews, hospital visits, and real-time feedback
• Champion patient safety initiatives, including event reporting and continuous improvement efforts
• Support adoption of new medical advancements, standards of care, and clinical best practices
• Partner with teams to improve client communication, case management, and follow-up care
• Oversee medical record quality, equipment standards, and clinical compliance
• Manage medical-related client concerns and board complaints through resolution
• Foster a culture of collaboration, accountability, and psychological safety
• Partner with Field Leadership, Medical Affairs, and operations to align priorities and execution
• Support recruiting, hiring, and onboarding of veterinarians, including new graduates
• Proactively identify and address medical, staffing, and operational challenges
• Serve as the medical voice within the field leadership team
• Mentor and grow Medical Directors and veterinarians through coaching and development planning
• Support onboarding, training, and integration of new doctors
• Guide teams on improving efficiency, productivity, and team-based care delivery
• Create an environment that supports continuous learning and career growth

Group Medical Director – Specialty

• Primary point of clinical contact for IOVANCE clinical trials
• Co-manages program development and reports directly to Executive Medical Director
• Monitors clinical trials including oversight of all aspects of trial conduct and safety
• Supports data analysis and assembly
• Contributes to the preparation of abstracts, presentations, and manuscripts

Associate Medical Director

• The Chief Medical Officer (CMO) provides service to the medical staff and hospital leadership for the Market in order to assist them in fulfilling their mission, plans and objectives which includes their responsibilities to the patient and the community for the provision of quality and cost-effective care.
• Provides an effective bridge between Market management staff and facilities medical staffs to create superior relationships with physicians and to secure physician input into major decisions.
• Directly responsible to the CCO for centralized medical staff functions such as medical staff development plan and recruitment.
• Supports the formal medical staff function at all facilities.
• Holds self out as a resource in dealing with difficult medical staff decisions.
• Sets a universal standard for the delivery of patient care.
• Participates and assists in the development of plans and implementation in all service line and patient care competency development.
• Works directly with the CCO at Trinity Health Mid-Atlantic in bridging the clinical arena of the Market to the development of Trinity Health standards of performance and Trinity Health policy.
• Supervises and manages the medical affairs division to ensure achievement of objectives in a cost-effective manner and to ensure the continued improvement of physician/physician, and physician/administration and physician/community relationships.

Chief Medical Officer

• Lead and scale interdisciplinary care teams that support patients across the full acute care continuum at a national scale, fostering a culture of excellence and clinical rigor.
• Responsible for hiring and managing the leaders of a growing team of physicians and advanced practice providers.
• Drive the strategy and business success for episodic care in the post-ED, post-hospital, and post-acute phases.
• Instrument a reliable AI-enabled system that surfaces high value care pathways that are personalized to the patient context.
• Build and scale a high-touch, virtual in-home "observation" level of care program.
• Leverage deep intelligence from acute events to implement critical safety patterns and quality standards across the entire enterprise.

National Medical Director – Episodic Care

• Provides overall medical direction and supervision of the organization's OTP and MAT services.
• Maintains responsibility for the quality, integrity, and effectiveness of medical and nursing services.
• Ensures compliance with applicable federal, state, DEA, SAMHSA, CARF, and other regulatory requirements.
• Collaborates with organizational leadership to establish, implement, and evaluate medical policies, procedures, and clinical protocols.
• Provides clinical consultation and guidance to providers, nursing staff, counselors, and interdisciplinary treatment teams.
• Participates in quality assurance, utilization review, risk management, and performance improvement initiatives.
• Serves as the medical subject matter expert regarding substance use disorder treatment and evidence-based practices.
• Conducts comprehensive medical evaluations, physical examinations, and assessments for patients seeking treatment.
• Reviews medical histories, laboratory results, toxicology reports, and other diagnostic information.
• Diagnoses and treats substance use disorders and co-occurring medical conditions within the scope of practice.
• Develops and oversees individualized treatment plans.
• Prescribes and manages medications utilized in OTP and MAT programs, including methadone, buprenorphine, and other approved medications as clinically appropriate.
• Determines patient eligibility for admission, continuation of care, transfer, and discharge from treatment services.
• Monitors patient progress and adjusts treatment plans based on clinical presentation, treatment response, toxicology results, and interdisciplinary team recommendations.
• Assesses psychiatric and behavioral health needs and facilitates referral to specialty services when appropriate.
• Provides patient education regarding treatment options, medication risks and benefits, overdose prevention, infectious diseases, and recovery support services.
• Oversees methadone induction, stabilization, maintenance, and medically supervised withdrawal protocols.
• Reviews and approves dosing determinations consistent with regulatory requirements and clinical best practices.
• Determines eligibility for take-home medications and approves take-home schedules in accordance with federal and state regulations.
• Ensures proper documentation and authorization of medication orders and verbal orders.
• Monitors and manages the treatment of high-risk or medically complex patients, including pregnant individuals and patients with significant medical comorbidities.
• Ensures all required medical assessments, laboratory testing, and ongoing evaluations are completed in a timely manner.
• Provides clinical supervision and oversight to medical providers, nursing personnel, and other assigned staff.
• Participates in recruitment, onboarding, performance management, coaching, and professional development of medical staff.

Medical Director – OTP

• Oversee a team of medical writers within assigned therapeutic areas and client accounts
• Review and revise medical content to ensure scientific accuracy and alignment with client strategies
• Counsel and serve as integral partner to clients in the development of various medical strategies
• Serve as the primary medical point of contact for clients on projects and deliverables
• Ensure all deliverables meet the highest standards of scientific accuracy, consistency, and compliance
• Understand project scopes and statuses and partner with account/project leads
• Contribute to business growth by supporting the development of new business proposals

• Lead, manage, mentor, and support a group of 30-40 clinicians
• Provide continuous improvement feedback, and quarterly quality and performance evaluations for individual clinicians
• Work closely with the Director of Nutrition, VP of Clinical Services on projects to improve care delivery and practice efficiency
• Develop, implement, and monitor clinical protocols and standards
• Actively promote a positive and inclusive team culture
• Work closely with senior leadership to align clinical strategies with overall business goals

Regional Medical Director

• Support BeOne clinical assets and pipeline by executing clinical development programs
• Facilitate generation of, author, update, and/or review key documents
• Partner with clinical operations and other functional areas for successful implementation and execution of clinical studies
• Provide scientific expertise for selection of investigator and vendors
• Train BeOne colleagues and study site staff on the therapeutic area, molecule, and/or clinical protocol
• Provide scientific and medical support throughout the conduct of clinical trials
• Review, query, and analyze clinical trial data
• Build and maintain opinion leader/investigator networks

Medical Director, Hematology

• Supports operations in the form of case review on both medical and regulatory matters.
• Develops claim adjudication criteria for situations requiring medical judgment.
• Provides input on issues and operational policies, processes, and procedures.
• Educates staff and medical community on various aspects of medical policy and program administration.
• May develop and update medical policy in consultation with appropriate regulatory personnel, medical consultants, and professional societies.
• Develops external relationships with the medical community and serves as liaison between these entities and the contractors.
• Reviews physician and provider practice pattern analysis and other statistical data related to unusual medical service utilization.
• Conducts research into new or controversial medical procedures and technology.

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