Medical Director

• 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

• 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

• Supporting the US Medical Affairs Lead with the development and execution of the US Medical Launch Plan for hepatology.
• Understanding the evolving US healthcare environment (provider/expert) and payer landscape and translating that knowledge into the medical strategy, objectives, and all activities.
• Planning and execution of medical tactics in collaboration with the cross-functional Medical Matrix Team.
• Prioritizing investment in medical activities to deliver the greatest, strategically aligned, impact on patient care measured via GSK’s Medical Impact Framework.
• Leading advice seeking activities and other external engagements to advance scientific and medical understanding of the appropriate development and use of medicines, the management of the disease, and patient care.
• Supporting medical grants, sponsorships, and other collaborations through development of the associated asset strategy.
• Partnering with Medical Communications & Scientific Training and Medical Information stakeholders to ensure communication goals and medical materials created align with the US medicine strategy and business needs.
• In collaboration with field medical, identifying relevant external experts and key on-line influencers and supporting the development of an external engagement plan.
• In partnership with the US Medical Affairs Lead, providing input to shape clinical and health outcomes evidence plans to support anticipated US Market needs.
• Applying sound medical governance for all activities.

Medical Director, Hepatology

• Collaborate with physicians, scientists, regulatory professionals, biostatisticians, executive staff, and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials
• Use medical expertise to contribute to the end-to-end (protocol concept to final study report) and timely delivery of clinical trials while ensuring patient safety, scientific integrity, and consistency with the clinical development strategy, for regulatory approvals, payor reimbursement, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making
• Ensure high-quality protocol development aligned with the Clinical Development Plan to effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
• Assume medical responsibility for clinical trials with active participation in real-time medical monitoring, including patient eligibility assessment, study design questions, and addressing urgent safety questions (with inclusion of Safety/ PV as relevant).
• Assume responsibility for medical review of clinical trial data, both directly and/or via oversight of delegated medical review.
• Oversee blinded review of data packages intended for IDMCs.
• Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
• Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population.
• Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, and Pharmacology to respond to health authority and ethics committee queries.
• Collaborate with Principal Investigators in the authoring of publications (abstracts, posters, manuscripts) associated with clinical data.
• Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of GSK’s vision.
• Serve as a core member of the Clinical Matrix Team for one or more assets in development.
• Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate.

Medical Director – Oncology Clinical Development

• Provide expert leadership in clinical safety and pharmacovigilance for oncology assets, including signal evaluation, benefit–risk assessment and proactive risk-management strategies.
• Oversee the review, interpretation and communication of safety data; identify, escalate and manage safety issues through established safety governance forums.
• Develop and implement safety strategies, policies and processes aligned with Global Safety operational and strategic plans.
• Coach and mentor medical and scientific colleagues in SERM in signal evaluation, risk management, and preparation of regulatory safety deliverables.
• Lead within a global, cross-functional matrix, building strong collaborative relationships and influencing internal and external stakeholders on safety topics.
• Lead or oversee SERM safety input into due diligence and other key strategic activities, ensuring safety perspectives shape decision-making.

Senior Medical Director

• Responsible for medical and scientific oversight of clinical trials in Internal Medicine
• Provides timely, study-related medical information and guidance
• Conducts and documents periodic safety data review and ongoing clinical/medical data review
• Represents the study team in internal protocol review governance submissions and interactions
• Develops site selection criteria and ensures protocol training is delivered to site-facing colleagues
• Ensures TMF compliance for clinical documents
• Develops clinical guidance and reviews safety data

Clinical Development Medical Director, MD Required

• 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

• Contribute to the planning and execution of medical strategies and tactics for Pfizer’s dermatology franchise
• Provide Pfizer brand teams with customer and clinical insights
• Develop long-term relationships with key healthcare stakeholders
• Collaborate with cross functional colleagues to drive US strategic direction for the brands
• Support internal medical training curriculum in collaboration with the I&I medical affairs capabilities group

Medical Director, Dermatology

• Leverage your background in Pain Medicine disciplines to deliver evidence-based medical reviews that support high-quality patient care.
• Collaborate with healthcare providers and stay current on healthcare regulations and industry developments as you review a wide range of cases.
• Start training remotely in a structured environment with support from trainers, mentors, and leadership to set you up for success.
• Complete time-sensitive, specialized evidence-based medical case reviews for medical necessity on EviCore’s case management software.
• Conduct physician consultation (peer-to-peer) calls with referring providers to discuss evidence–based medical necessity and appropriateness of the requested service or treatment.
• Leverage your clinical expertise to recommend alternative services or treatments as necessary.
• Work collaboratively with over 500 EviCore physician colleagues to help ensure patients receive proper care via evidence-based decision making.

Medical Director – Pain Medicine

• Providing consultation and appropriate mortality assessment of complex medical files
• Interpreting laboratory and medical test results used to detect, diagnose, or monitor diseases that are seen in underwriting risk assessment
• Participating in the continuing education of the JH underwriting team
• Supporting research and development of manual updates with evidence-based research if needed

• 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

• Lead clinical strategy, medical management, and regulatory performance for Medicaid line of business across Pennsylvania
• Partner with Quality, Utilization Management, Case/Disease Management, Pharmacy, Behavioral Health, Provider Network, and Compliance to deliver high‑quality, cost‑effective care
• Serve as primary physician liaison with state Medicaid agency and key provider partners
• Provide clinical direction for Medicaid product, including medical policy, clinical guidelines, and care model design across UM/CM/DM
• Ensure determinations are clinically sound and timely
• Oversee grievance and appeals clinical reviews and author evidence‑based rationales
• Drive quality improvement, close gaps in care, and monitor outcomes and utilization trends
• Serve as clinical liaison to hospitals, systems, and practices; educate on medical policies/criteria
• Collaborate with Provider Network on value‑based models, performance feedback, appeals resolution themes, and market growth priorities
• Act as the plan’s clinical spokesperson with state Medicaid agency and advisory bodies

Medical Director – Medicaid

• Responsible for helping to develop US medical strategy and perspective
• Contribute to the cross-functional Medical Matrix Team to tailor / adapt global asset strategy for US specific customer needs
• Engage with external communities to advance scientific and medical understanding
• Coordinate with the US MSLs, GMAL on joint global and US engagement of top US based EEs

Medical Director, Respiratory

• Assist the Chief Medical Director to direct and coordinate the medical management, quality improvement and credentialing functions for the business unit
• Provides medical leadership of all for utilization management, cost containment, and medical quality improvement activities
• Performs medical review activities pertaining to utilization review, quality assurance, and medical review of complex, controversial, or experimental medical services, ensuring timely and quality decision making
• Supports effective implementation of performance improvement initiatives for capitated providers
• Assists Chief Medical Director in planning and establishing goals and policies to improve quality and cost-effectiveness of care and service for members
• Provides medical expertise in the operation of approved quality improvement and utilization management programs in accordance with regulatory, state, corporate, and accreditation requirements
• Assists the Chief Medical Director in the functioning of the physician committees including committee structure, processes, and membership
• Conduct regular rounds to assess and coordinate care for high-risk patients, collaborating with care management teams to optimize outcomes
• Collaborates effectively with clinical teams, network providers, appeals team, medical and pharmacy consultants for reviewing complex cases and medical necessity appeals
• Participates in provider network development and new market expansion as appropriate
• Assists in the development and implementation of physician education with respect to clinical issues and policies
• Identifies utilization review studies and evaluates adverse trends in utilization of medical services, unusual provider practice patterns, and adequacy of benefit/payment components
• Identifies clinical quality improvement studies to assist in reducing unwarranted variation in clinical practice in order to improve the quality and cost of care
• Interfaces with physicians and other providers in order to facilitate implementation of recommendations to providers that would improve utilization and health care quality
• Reviews claims involving complex, controversial, or unusual or new services in order to determine medical necessity and appropriate payment
• Develops alliances with the provider community through the development and implementation of the medical management programs
• Represents the business unit before various publics both locally and nationally on medical philosophy, policies, and related issues
• Represents the business unit at appropriate state committees and other ad hoc committees
• May be required to work weekends and holidays in support of business operations, as needed

• Provide medical and scientific expertise for Clinical Trials and accountability for one or more clinical studies
• Design development strategy for multiple protocols
• Monitor study safety issues and provide input to serious adverse events (SAEs) reports
• Provides protocol specific training to study team, investigators, and others
• Conduct medical review and interpretation of efficacy and safety data from clinical trials

Clinical Development Medical Director, MD required

• 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

• Accountable for safety across the study
• Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level
• Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP)
• Performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead
• Monitor study safety issues and provide input to serious adverse events (SAEs) reports
• Provides appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context required for benefit-risk assessments
• Participates in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications
• Communicates safety information to sites across the study and provides responses to questions on safety
• Provide medical input during development and updates to the clinical development plan
• Designs clinical studies to meet the stated objectives
• Ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and have been reviewed by IRB/IECs
• Provides medical input into country feasibility

Director, Clinical Development

• 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

• 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 reviews with attending physicians or other providers to discuss review determinations and patients’ office visits with providers and external physicians.
• May conduct peer-to-peer clinical appeal case reviews with attending physicians or other ordering providers to discuss review determinations.
• Serves as a resource and consultant for other areas of the company.
• May be required to represent the company to external entities and/or serve on internal and/or external committees.
• May chair company committees.
• Interprets medical policies and clinical guidelines.
• May develop and propose new medical policies based on changes in healthcare.
• Leads, develops, directs, and implements clinical and non-clinical activities that impact health care quality, cost, and outcomes.
• Identifies and develops opportunities for innovation to increase effectiveness and quality.
• Travel to an office for in-person meetings when necessary.

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