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 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

• 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

Associate Medical Director

• Develop strategy and tactics for an integrated Medical Plan (Medical Education, Medical Communications and Publications, Health Outcomes, Safety, and Clinical Research including Phase IIIB-IV and Investigator Sponsored Trials) and annual budget for assigned the respective therapeutic area products
• Execute the Integrated Medical Plan to ensure on-time and on-budget delivery of all tactical activities and deliverables
• Communicate the details and progress of the Medical Plan to Management, the Core Team, and all parties responsible for execution
• Provide relevant data evidence to ensure that strategy is clearly defined and consistent with clinical development and commercial strategic objectives
• Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans
• Provide impactful medical strategy and expertise to Clinical, Commercial, Market Access, and Regulatory partners
• Ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of the respective therapeutic area products, cultivating a culture of teamwork and collaboration to ensure the delivery of key priorities
• Provide medical leadership and expertise to sales, marketing, legal, and regulatory functions for marketed products and drugs in development
• Pro-actively provide scientific guidance and collaborate with field team, marketing, HEVA, Market Access, and sales teams
• Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans, managing resources and budgets.
• Partner with Field Medical Head, Medical Directors, and other internal partners to manage high-level regional stakeholder relationships, contribute to medical engagement planning, and oversee the tactical budget.
• Collaborate with the health economics team to address questions and opportunities
• Provide medical review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulations
• Review and approve medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs, and Commercial materials
• Provide medical review of applications for independent medical education grants
• Provide medical review of training materials for medical and commercial employees
• Maintain up-to-date working knowledge and adherence of all applicable prevailing guidance, regulation, and law (including but not limited to FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ISPOR)
• Support the execution of US Phase IIIB-IV clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, clinical trial guidelines, and accurate and timely reporting of study data
• Oversee conduct of all clinical studies in adherence to both Company standards and government/industry regulations (GCP/ICH)
• Review and approve IST (Investigator Sponsored Trial) concepts/protocols according to applicable SOPs
• Identify and co-create research collaboration opportunities within the respective therapeutic area to address key questions in the delivery of patient care
• Identify needs for post-marketing clinical trials and registries and oversee their management and execution
• Ensure that all data generated by the company or investigator-sponsored trials are publicly presented in an appropriate and timely fashion and in a fair and balanced manner
• Partner with US Drug Safety in the management of clinical trial adverse events, post-marketing safety data, and in the communication of identified safety signals
• Identify and communicate Product Alerts to the Core Team (in conjunction with US Drug Safety, USRAMP, GMA)
• Develop and maintain close professional relationships with Key Thought Leaders (physicians and researchers) within the respective therapeutic area medical and scientific community
• Lead medical and scientific advisory board discussions to identify and elevate medically focused opportunities, resources, and strategic action within >
• Foster the establishment and maintenance of external scientific advisory boards and assist in advocacy development
• Interact with experts at medical meetings, advisory boards, and outreach meetings to represent Sanofi and strengthen its reputation in the therapeutic area
• Provide disease state and product training to internal and external stakeholders
• Remain informed of current developments within the respective therapeutic area medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, and professional associations
• Performs other duties as assigned.

Medical Director, U.S. Immunology

• Oversees the administration of behavioral health services to ensure members receive appropriate, high-quality, and cost-effective care
• Provides clinical consultation and strategic guidance to strengthen clinical operations
• Supports the design and implementation of initiatives that improve quality, outcomes, and affordability
• Identifies and develops opportunities for innovation to increase effectiveness and quality
• Conducts peer-to-peer clinical reviews with attending physicians or other providers
• Serves as a resource and consultant to other areas of the company
• Attends Behavioral Health interdisciplinary team (IDT) meetings and other team-related meetings regularly

Behavioral Health Medical Director – Psychiatrist

• Planning clinical trials (designing, collaborating on operational plans, etc.) based on the clinical development strategy
• Medical oversight and overall conduct of ongoing or new clinical trials for investigational or marketed drugs
• Analyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication
• Participating in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds
• Supporting business development assessments of external opportunities
• Actively engaging with other functional areas in support of study execution
• Working closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects
• Assisting the team in ensuring that other colleagues are informed of the progress of studies of the company and competitors' drugs
• Providing expert opinions, internally and externally, on relevant scientific questions within their responsibility
• Maintaining awareness of scientific developments within his/her area of expertise
• Identifying scientifically and operationally strong investigators who can assist in the development of the company’s investigational and marketed drugs
• Establishing communications with prominent clinical investigators in his/her particular field of interest
• Attending appropriate scientific meetings to maintain competency and awareness of research activities

Clinical Director, Clinical Research, Ophthalmology

• Develop and execute compelling scientific content
• Analyze complex clinical and scientific data
• Counsel clients in medical strategies and medical communications
• Serve as the primary point of contact for clients
• Ensure deliverables meet scientific accuracy and compliance standards
• Provide leadership and mentorship to medical writers
• Contribute to business growth by supporting new business proposals

• planning and directing clinical research activities involving new or marketed medicines in the Late Stage Oncology - Late Stage therapeutic area
• manage the entire cycle of clinical development for their assigned studies including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication
• Evaluating pre-clinical and translational work for generating early clinical development plans and Investigational New Drug applications
• Developing clinical development strategies for investigational or marketed RCC drugs
• Planning clinical trials based on the clinical development strategy
• Medical oversight and overall conduct of ongoing or new clinical trials for investigational or marketed drugs
• Analyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy
• Participating in internal and joint internal/external research project teams relevant to drug development
• Supporting business development assessments of external opportunities

Senior Clinical Director, Clinical Research

• Responsible for appeal reviews for physical health medical services
• Ensure the appropriate and most cost-effective medical care is received
• Develop and implement programs to improve quality, cost, and outcomes
• Provide clinical consultation and serve as clinical/strategic advisor to enhance clinical operations
• Identify cost of care opportunities
• Supports clinicians to ensure timely and consistent responses to members and providers
• Provides guidance for clinical operational aspects of a program
• Conduct peer-to-peer clinical case reviews with attending physicians or other ordering providers
• Serve as a resource and consultant for other areas of the company

Medical Director – Oncology

• Responsible for the appeal reviews for physical health medical services
• Supports clinicians to ensure timely and consistent responses to members and providers
• Provides guidance for clinical operational aspects of a program
• Conducts peer-to-peer clinical case reviews with attending physicians
• Serves as a resource and consultant for other areas of the company
• May chair company committees
• Interprets medical policies and clinical guidelines
• Identifies and develops opportunities for innovation to increase effectiveness and quality

Appeals Medical Director – Cardiology

• Plan and execute Medical strategy and engagement for appropriate assigned customers within a territory, compliantly coordinating with other Pfizer colleagues as needed to achieve Medical objectives
• Maintain required level of knowledge of relevant TA/disease states and Pfizer medicines, providing therapeutic area/product information to both internal and external stakeholders as needed
• Serve as a conduit and resource for Medical Information and customer insights, providing requested information to HCPs as allowed by Pfizer guidance and sharing customer viewpoints with Pfizer as appropriate
• Understand the priorities of Pfizer Medical Affairs in order to contribute to Medical content strategy development and execute aligned Field Medical tactics
• Maintain effective and appropriate communication and collaboration among headquarters Medical colleagues, Medical Information, and other Pfizer Field Medical colleagues
• Demonstrate expertise in communication across multiple channels, including, but not limited to, live and virtual presentations in small or large settings, written communication, and telephone or virtual conversations
• Optimize patient centricity of Medical communications and deliverables, incorporating Health Literacy and cultural awareness principles to ensure that patients remain the ultimate focus
• Deliver approved medical content about Pfizer medicines and relevant topics in the designated therapeutic area
• Identify and seek medical engagement from priority customer segments in assigned Therapeutic Area
• Provide truthful, accurate, and scientifically supported information in response to direct unsolicited medical requests from HCPs in a manner that complies with all applicable Pfizer guidelines, policies, and procedures
• Lead advisory boards (develop BRF, Agency collaboration) with manager oversight
• Field relevant inbound queries from HCPs via established triage process
• In collaboration with Global Medical Affairs colleagues, partner with Oncology Research & Development and Global Product Development (GPD) in the identification of potential sites for Pfizer-sponsored clinical trials
• Appropriately provide Medical support throughout the Investigator Sponsored Research (ISR) process
• Cultivate research and therapeutic area expertise, including familiarity with latest congress data and disease state literature
• Provide Asset leadership
• Understand the principles of study design, methodology, data analysis, and interpretation and communicate these concepts with customers
• Strong territory leadership
• Reactively and proactively communicate with local Patient Advocacy Group(s), as appropriate, in close collaboration with Corporate Affairs and HQ Medical Affairs
• Deliver insights on local patient organization structure, capabilities, and patient population needs
• Serve on Medical and/or TA and asset cross-functional committees, as appropriate
• Represent Pfizer Medical Affairs leadership with clinical/professional associations and/or societies, consistently demonstrating medical professionalism in all interactions
• Mentorship – Onboarding partner, ad board and study lead mentor
• Participate in special projects as needed

Field Medical Director – Oncology

• Develop and manage the Clinical Policy, Regulatory, and Compliance functions within the Office of Clinical Affairs.
• Ensure clinical operations meet healthcare laws and standards.
• Develop and maintain regulatory policies.
• Manage compliance risks and guide policy-related submissions.
• Advise senior leadership and work closely with teams across the organization.

Medical Director, Clinical Regulatory Affairs

• Develop U.S. medical objectives and strategies across the rare hematology portfolio, aligned with U.S. commercial goals
• Provide medical input to brand teams regarding strategy, tactics, and development of claims
• Serve as the internal expert for rare hematologic conditions and products, and support the field-based U.S. Medical Affairs team
• Develop strategies for and implement medical advisory boards
• Lead execution of the strategic U.S. investigator-sponsored study program

Senior Medical Director, Rare Hematology

• Acts as medical expert and leader in interactions with external stakeholders
• Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.
• Designs and develops more efficient and innovative, yet robust Phase 2/3 programs.
• Works closely with discovery teams to provide input on the next generation of targets in the field and leads the development of plans for Phase 1 clinical testing for initial characterization of the molecules PK/PD and safety.
• Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support from Global Patient Safety.
• Plans and executes publication and clinical communication strategy in coordination with Publications team.
• Provides input to key external presentations.
• Ensures quality of all clinical documents (e.g., Investigators’ Brochure, protocol, study report, clinical components of regulatory submissions, safety related documents).
• Develops written responses to regulatory agency questions and regulatory submission documents.

Senior Medical Director, Clinical Development, Cardiovascular/Metabolism

• Support all lines of business which includes Commercial and Government Programs
• Collaborate with value-based teams, Behavioral Health and Pharmacy; supports accounts and activities for cross functional areas by region, where applicable
• Supports sales teams as assigned by region
• Guides, supports and consults with nurse reviewers on pre-authorization, concurrent and retrospective review issues, post-service reviews, pre-determinations and decisions, where applicable
• Consult with/support case management to determine best course for members, assist with PG and address issues
• Develops and maintains effective collaborative relationships with providers in assigned geographic areas
• This includes on site or virtual review of performance and coaching activities with physicians, hospitals and ancillary providers
• May provide input into provider credentialing, profiling and communication initiatives
• Responsible for data analysis on case management and utilization, identify issues and escalate as necessary to senior management
• Interprets and analyzes available utilization, cost and quality reports and develops steps to address variances to target performance matrix
• Collaborates on documentation of monthly reporting address performance, issues and activities for assigned region
• Assists with assessment of network capabilities by region and collaborates with network management, contracting and value-based teams in addressing network gaps
• Creates/participates in internal or external educational activities for other members of the team/stakeholders across regional/functional areas
• Participates in Committee activities as assigned
• Assist with coverage across functional MD teams, as needed, including participation in calls for all areas
• Support medical policy development process, review medical and pharmacy policies and provide feedback regarding utilization to the development team
• Works with legal and mandate team to support Horizon’s compliance with the NJ Department of banking and insurance (DOBI)
• Backup chair for committees with internal and external stakeholders
• Performs medical reviews for the Clinical Inquiries Team (CIT) and support special investigations unit as needed
• Support development and implementation of reimbursement policies
• Assist with coverage across functional MD teams as needed including participation in calls for all areas

• Planning clinical trials (designing, collaborating on operational plans, etc.) based on the clinical development strategy.
• Medical oversight and overall conduct of ongoing or new clinical trials for investigational or marketed drugs.
• Analyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication.
• Supporting business development assessments of external opportunities.

Clinical Director, Clinical Research, Hematology

• Provide expert supervision to your team (Licensed or Non-Licensed), helping them grow within the NJ Children’s System of Care (CSOC).
• Maintain a manageable personal caseload (12-22 hours) to lead your team by example.
• Leverage your established reputation in throughout counties in New Jersey within the Care Management Organizations and Children's System of Care to ensure your team has a steady flow of cases.

Clinical Director – LCSW or LPC Required

Clinical Director – LCSW, LPC Required

• planning and directing clinical research activities involving new or marketed medicines in the Oncology therapeutic area
• manage the entire cycle of clinical development for their assigned studies including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication
• Evaluating pre-clinical and translational work for generating early clinical development plans and Investigational New Drug applications
• Developing clinical development strategies for investigational or marketed Hematology drugs
• Planning clinical trials based on the clinical development strategy
• Medical oversight and overall conduct of ongoing or new clinical trials
• Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy
• Participating in internal and joint internal/external research project teams relevant to the development of new compounds
• Supporting business development assessments of external opportunities

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Medical Director

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

Medical Director/Senior Medical Director, Oncology Late Development

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Medical Director, U.S. Immunology

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Associate Medical Director

Senior Clinical Director, Clinical Research

Medical Director – Oncology

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Medical Director, Clinical Regulatory Affairs

Senior Medical Director, Rare Hematology

Senior Medical Director, Clinical Development, Cardiovascular/Metabolism

Medical Director

Clinical Director, Clinical Research, Hematology

Clinical Director – LCSW or LPC Required

Clinical Director – LCSW, LPC Required

Senior Clinical Director, Clinical Research, Hematology