Medical Director

• Supervise patient and family care as specified by the plan of care, assessing appropriateness, continuity, service, and quality of care
• Support and manage Interdisciplinary Team (IDT) including scheduling, productivity, mentoring and monitoring, 1x1’s, pay practices and timekeeping
• Oversee the consultative process between the Medical Director and the members of the Interdisciplinary Team (IDT)
• Ensure adherence to the rules and regulations of state and federal regulatory agencies
• Attend/Lead Interdisciplinary Team (IDT) meetings
• Process EMR documentation workflow as needed

Pediatric Hospice Director – Clinical Services

• Own end‑to‑end accountability for the EDC platform across strategy, delivery, operations, and value realization
• Define and govern multi‑year product vision and roadmap, aligned with Pfizer clinical and digital strategies
• Facilitate and drive final prioritization and trade‑off decisions across scope, funding, risk, and timeline
• Ensure compliance, data integrity, and audit readiness in partnership with Regulatory, Quality, and IT stakeholders
• Responsible for decisions that impact the overall product vision and metrics (e.g., Objectives & Key Results (OKRs) fulfillment
• Create, maintain, and execute against a prioritized roadmap for the Clinical business
• Establish strong relationships with key business stakeholders and serve as a strategic partner in product decision making
• Work with cross-functional teams of architects, engineers, and designers to deliver customer-centric product features
• Apply user-centered design principles and practices in the product development lifecycle
• Exercise strong decision-making mandate across cross-functional teams
• Stay in sync with the Product Owners on priorities and day-to-day decision making
• Prepare and support the agile team on product demos
• Contribute to the overall success and lifecycle of the product during definition, design, user story/requirement creation, documentation, launch, management updates, and metrics
• Oversee creation of user stories/specs and data analysis to justify product decisions and apply key learnings
• Create and deliver presentations to stakeholders and users
• Responsible for managing and/or retiring other CDMS systems (i.e. RAVE, Inform, DMW, OC)

Director, Clinical Technology, EDC Product Manager

• Lead a goal-oriented hospital housekeeping department to create a team environment that is effective, productive, and rewarding
• Provide leadership that supports a team environment that fosters morale, passion, quality, and respect
• Demonstrate continuous ability to maintain and/or improve customer and patient satisfaction
• Lead and manage team member recruiting, training, development, and assignments
• Perform daily inspections and assessments and coach and counsel team members
• Collaborate with department, facility, and company leadership to achieve goals
• Analyze data and make adjustments to meet facility, budget, and compliance goals
• Execute, maintain, and monitor quality control systems and budgets
• Drive compliance with health, safety, and industry regulatory agencies

Healthcare Housekeeping Executive Director

• Support the design and execution of surveillance/epidemiology and RWE studies involving both primary data collection and secondary analyses
• Partner with cross-functional teams to ensure alignment of medical education across various channels with medical priorities
• Translate complex and emerging scientific data into clear, actionable insights for internal stakeholders
• Contribute to long-range medical planning, including lifecycle management and integration of new data into US medical strategy
• Partner with Field Medical to shape scientific exchange priorities, field insights collection, and feedback loops to inform strategy refinement
• Monitor and assess emerging scientific literature, competitive landscape, and public health trends relevant to pneumococcal pediatric epidemiology and immunization, proactively recommending strategic implications
• Guide external engagement strategy with national and regional medical societies, public health stakeholders, and professional organizations to support evidence-based pneumococcal pediatric immunization decision-making
• Provide medical review of grants and partnership activities, and partner cross-functionally to support strategy on equitable access and awareness of pneumococcal pediatric vaccination
• Demonstrate expertise in communication across multiple channels, including, but not limited to, live and virtual presentations in small or large settings, and written communication

Director, US Medical Affairs – Vaccines

Director, US Medical Affairs – Vaccines, MD

• Reporting directly to the Chief Executive Officer, the Chief Medical Officer is a vital member of the Executive Leadership team.
• Serve as the senior executive for all clinical and medical-related matters.
• Champion the needs of end-users, including clinicians, nurses, and administrative staff.
• Drive clinical innovation, oversee patient safety, and advance OP's overarching business strategy.
• Collaborate with the Executive Leadership team to align clinical solutions with organizational goals.
• Monitor healthcare industry trends and provide actionable competitive intelligence.
• Identify macro-level strategic growth areas.
• Serve as a thought leader in pediatric healthcare and advocate for OP at industry events.
• Develop and maintain relationships with national pediatric organizations and industry leaders.
• Lead and engage with the OP Clinical Advisory Board.

Chief Medical Officer

• Serve as a senior clinical leader and addiction medicine subject matter expert across the organization.
• Partner with Clinical Services leadership to strengthen clinical quality, consistency, and patient safety across Boulder’s care delivery model.
• Lead routine review and refinement of clinical protocols, formulary standards, and evidence-based practice guidelines.
• Support quality assurance activities, chart review processes, and clinical audits to identify opportunities for improvement.
• Provide consultation and guidance on complex clinical cases and emerging clinical issues.
• Ensure Boulder’s clinical standards remain aligned with current evidence, regulatory requirements, and payer expectations.
• Partner with Clinical Services leadership to strengthen clinical leadership capabilities across the organization.
• Provide mentorship, coaching, and support to clinical leaders and clinicians navigating complex clinical and operational challenges.
• Help establish and reinforce standards of clinical excellence, professional growth, and evidence-based practice.
• Contribute physician leadership and oversight to clinician education, onboarding standards, and ongoing clinical development programs.
• Support the development of systems that promote accountability, consistency, and continuous improvement across the clinical organization.
• Translate quality findings, operational priorities, and emerging evidence into scalable clinical workflows and care delivery standards.
• Identify gaps in clinical processes, policies, and infrastructure and partner across teams to implement solutions.
• Support implementation of new clinical initiatives and ensure clinical best practices are operationally viable and consistently applied.
• Drive adoption of new clinical workflows, protocols, and care models across a distributed clinical workforce.
• Partner with Medical Affairs and Clinical Services leadership to evaluate and support expansion into new service lines and care models.
• Assess clinical readiness, staffing considerations, protocol requirements, and quality implications for new programs.
• Ensure new services are designed with appropriate clinical governance, quality standards, and outcome measurement strategies.
• Contribute clinical expertise to Boulder’s long-term vision of comprehensive substance use disorder care.
• Serve as a clinical liaison to Product, Operations, Analytics, and other cross-functional teams.
• Translate clinical priorities into product requirements, workflows, and operational processes.
• Provide clinical input on care delivery technology, clinical decision support tools, AI-enabled workflows, and platform enhancements.
• Ensure operational and product changes are evaluated through the lens of patient safety, clinician experience, clinical effectiveness, and quality.

Medical Director – Addiction Medicine, Telehealth

• Oversee the performance and growth of Customer Service, Prescription Processing, Client-specific teams, managing both internal staff and external vendors
• Lead operational excellence across central fill pharmacy networks and courier delivery operations
• Lead your team with Key Performance Indicators (KPIs) to drive business success and increase efficiency while lowering the cost-to-fill on an annual basis
• Manage quality, turnaround time (TAT), and customer satisfaction metrics to ensure FuzeRx remains the preferred infrastructure partner for telehealth and pharma partners
• Establish requirements for capabilities and reporting, collaborating cross-functionally to deliver data-driven insights
• Analyze data to forecast staffing needs based on program performance, optimizing resource allocation across multiple roles
• Lead a large team of managers, supervisors and team members, establishing an environment of positive employee engagement and experience

Director, Rx Clinical Operations

• Provides strategic and operational leadership for GUMC’s Graduate Health & Life Sciences Research Library
• Advances a comprehensive vision integrating services, education, collections, and library services in support of GUMC’s education, research, and clinical missions
• Advocates for faculty, student, clinician, and researcher needs in Medical Center decision-making related to information resources and services
• Recruits, develops, mentors, and leads a diverse workforce of professional librarians, staff, and student employees
• Supports teaching and learning through direct instruction, collaboration with faculty, and leadership in information literacy, data literacy, AI literacy and technology-enabled education

Senior Associate Dean and Director, Dahlgren Memorial Library

• Work within the Medical Affairs organization to identify, establish, and manage collaborative professional relationships with community-based scientific leaders (SLs) and healthcare providers.
• Conduct peer-level scientific discussions and maintain a reliable presence to ensure SLs have a Medical Affairs contact within our company.
• Engage in proactive non-product discussions regarding scientific issues to understand real-world prevention gaps, persistent disparities, and barriers to uptake across various care settings.
• Facilitate appropriate scientific exchange of information with SLs, including integration of scientific knowledge with actionable insights to inform our Company's research, development and strategies.
• Communicate external stakeholder opinions, insights, and feedback on new data, clinical trends, and the evolving HIV treatment and prevention landscape to Medical Affairs HQ teams.
• Represent R&D at scientific meetings and congresses to understand the sentiment of the consumer and contribute to R&D debriefs, insight discussions, and post-congress reports.
• Develop and execute territory plans in alignment with global Virology strategy.
• Support data generation activities when requested by R&D leadership, including our company's Investigator Study Program (MISP).
• Identify potential investigators for participation in phase II-IV clinical development programs and provide scientific support for R&D sponsored trials as needed.
• Demonstrate and maintain in-depth knowledge of the assigned disease and therapeutic area(s) through educational efforts.
• Fully comply with all company policies and applicable laws, regulations, and ethical standards.

Virology Community MSL, Regional Medical Scientific Associate Director

• Provides medical oversight of assigned clinical studies in the duty as a medical monitor
• Often serves as primary medical contact for customers for assigned clinical studies
• Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department
• Responsible for protocol design and development, upon request
• Provides input into protocol amendments
• Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed
• Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data
• Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data
• Represents the Company at scientific and industry meetings
• Mentors staff to ensure an appropriate level of understanding regarding sound treatment and research principles of specific therapeutic area

Senior Director – Medical Monitor, Immunology/Rheumatology

• Establish and lead Umoja Biopharma’s Medical Affairs function.
• Build the function from the ground up—developing medical strategy, external engagement models, evidence generation plans, and field medical capabilities.
• Ensure the organization is positioned to effectively communicate scientific and clinical value to healthcare professionals, investigators, and key stakeholders.
• Define the vision, infrastructure, and roadmap for Medical Affairs to support Umoja’s transition into clinical development and beyond.
• Serve as the internal subject matter expert and strategic thought partner on scientific communication and external engagement.
• Develop and lead a KOL engagement strategy, building trusted relationships with external experts, investigators, and key institutions.

Executive Director, Medical Affairs

• Provide regulatory leadership and oversight for ongoing and planned in vivo CAR-T therapy programs.
• Develop and execute global regulatory strategies to support indication selection, trial design, and endpoints.
• Develop registration strategies and plans to achieve regulatory approvals.
• Lead global regulatory filings (IND/CTA/BLA/MAA submissions).
• Primary point of contact with global regulatory agencies.
• Communicate the regulatory strategy, risks, mitigations, and overall plans to various stakeholders.
• Identify, communicate, and propose resolutions to routine and complex issues.
• Provide regulatory advice and guidance to project teams.
• Collaborate closely with various teams to align overall strategy with scientific discoveries.
• Stay current on emerging trends, competitors, and regulatory guidance in applicable areas.
• Work with external program partners collaboratively and effectively.

Senior Director, Clinical Regulatory Affairs

• Architect and lead the company’s global approach to clinical trial site budgeting, investigator grant strategy, transparency compliance, and site/vendor payment governance across our clinical trial portfolio.
• Define Jade’s global investigator grant philosophy, including structured opening offer and negotiation parameters.
• Establish standards for invoiceables, conditional procedures, pass‑through costs, and country‑specific budgeting norms applicable across all Jade clinical studies.
• Oversee a full-service CRO partner responsible for operational execution of budgets, payments, reconciliation, and study financial controls.
• Build and maintain global site budget forecasts, ensuring just‑in‑time CRO funding, and support accruals, reconciliation, and inspection‑readiness.

Associate Director, Clinical Site Budgets & Payments

• Serve as a trusted GCP compliance advisor to all functions within study teams by promoting a culture of quality and helping teams integrate compliant practices into daily study execution and decision-making
• Analyze compliance metrics, audit findings, monitoring data, and operational trends across programs to identify systemic risks and opportunities for process improvement
• Apply risk-based judgment in interpreting and implementing GCP requirements, balancing regulatory expectations with operational realities to ensure compliance approaches are practical, defensible, and appropriate to the level of risk
• Drive initiatives to ensure continuous inspection readiness across clinical studies
• Assist in preparation for regulatory inspections and internal audits including readiness assessments and document reviews
• Support development of inspection storyboards and response strategies when needed
• Ensure study teams maintain inspection-ready documentation and evidence of ongoing compliance
• Support oversight of CROs and other clinical vendors to ensure compliance with contractual and regulatory expectations
• Partner with Development Outsourcing on defining and tracking vendor performance metrics and KPIs
• Participate in vendor governance meetings and performance reviews
• Identify trends or risks in vendor performance and recommend mitigation strategies
• Review and track vendor QEs
• Develop processes for oversight of monitoring activities conducted by CROs
• Review monitoring oversight plans, reports, and monitoring metrics
• Assess monitoring quality and compliance with monitoring plans
• Identify monitoring gaps and collaborate with study teams to address them
• Support identification and management of investigator or site non-compliance
• Assist study teams in evaluating protocol deviations and escalation needs
• Help develop remediation strategies for significant compliance issues
• Support study teams in identifying and appropriately escalating significant compliance issues, protocol deviations, and site noncompliance, ensuring issues are investigated, documented, and resolved in accordance with regulatory expectations
• Drive and support development and implementation of CAPAs from audits, inspections, or compliance reviews
• Track CAPA effectiveness and ensure timely closure
• Identify recurring issues and support continuous improvement initiatives
• Partner with QA to support internal and external GCP audits
• Assist with audit preparation and documentation review
• Support study teams in addressing audit findings
• Provide training to clinical teams on ICH-GCP, regulatory requirements, and internal SOPs
• Identify knowledge gaps and support development of compliance training programs
• Contribute to SOPs, guidance documents, and best practice materials.

Director, Clinical Compliance

• Acts as Clinical Operations program lead for assigned program(s)
• Represents Clinical Operations at the Clinical Development Team and/or Global Program Team
• Develops and executes program operational strategy
• Partners closely and effectively with other functions and functional heads to drive program forward
• Provides strategic and technical recommendations to senior leadership
• Directs the selection of CROs and other vendors (IxRS, Central Lab, ancillary/tech vendors)
• Acts as an escalation point for CRO/vendor issues
• Directs development of vendor Scopes of Work (SOW), scope changes, budgets, and vendor payments
• Partners with CRO and other vendors to deliver on study execution
• Creates and tracks clinical program budgets
• Directs risk mitigation, escalation, and resolution activities both internally as well as with sites and vendors
• Directs technical and strategic input into the development of clinical documents (protocols, monitoring plans, informed consent forms, investigator brochures, clinical study reports, etc.)
• Builds relationships with clinical sites, vendors, and key stakeholders
• Maintains understanding of external landscape and adjusts plans accordingly
• Represents Clinical Operations in cross-functional activities as assigned
• Plays a key role in the development and management of the Clinical Operations function; may act as a deputy for the Head of Clinical Operations as assigned
• Hires, manages, coaches, and mentors staff
• Contributes to building the organization.

Senior Director, Clinical Operations

• 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

• 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

• Design, implement, and improve education, quality, and accreditation programs
• Develop and manage training curriculum for clinical staff
• Design and deliver palliative care-specific education programs
• Integrate value-based care principles into training frameworks
• Oversee simulation-based training and competency assessments
• Lead the organization's QA/QI program and establish quality metrics
• Analyze clinical and operational data for improvement
• Collaborate with the Compliance Department for regulatory education

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