Medical Director

• Serve as the company's clinical nutrition expert for dysphagia, texture-modified diets, malnutrition, oral nutritional supplementation, and enteral nutrition support
• Monitor emerging clinical research, nutrition guidelines, and industry trends to ensure company recommendations remain evidence based.
• Develop and maintain clinical positioning for existing and future product portfolios.
• Support regulatory and medical review of nutrition-related claims and educational materials.
• Represent the company at national conferences, advisory boards, customer meetings, and educational events.

Director, Nutrition Science – Clinical Education

• Provide direct leadership for various IT clinical domains.
• Serve as primary IT lead for EMR planning and execution.
• Collaborate closely with implementation partners and QHC leadership.
• Act as key liaison with governance teams ensuring effective EMR implementation.

Director of Ancillary, Clinical Systems

• Lead end-to-end clinical supply planning activities across portfolio companies and phases of development. Ensure supply plans align with program timelines, enrollment assumptions, and development objectives. Support clinical trial material production and distribution activities.
• Support manufacturing campaigns, packaging runs, labeling activities, shipment planning, and global distribution of investigational products and ancillary supplies. Development and implement strategies to ensure study blinding requirements are met.
• Manage clinical supply forecasting and inventory oversight. Create and maintain demand forecasts, inventory plans, and supply scenarios for investigational product and for any comparators and/or auxiliary items required to support study execution while minimizing waste, shortages, and excess inventory.
• Ensure accurate tracking of inventory, shipments, forecasts, and supply performance indicators while supporting inspection readiness and compliance requirements. Identify and mitigate supply risks by proactively assessing potential supply chain constraints, manufacturing risks, and inventory vulnerabilities, and developing contingency plans to maintain uninterrupted clinical trial support.
• Coordinate external supply chain partners and vendors. Serve as the primary operational liaison for CMOs, packaging and labeling vendors, depots, IRT providers, and logistics partners to ensure timely and compliant supply execution.
• Collaborate closely with cross-functional stakeholders. Partner with Manufacturing, Clinical Development/Operations, Regulatory Affairs, Quality Assurance, and portfolio company leadership teams to align clinical supply activities with broader program objectives.
• Contribute to process development across the Aditum Bio portfolio. Help establish scalable clinical supply planning practices, vendor management frameworks, and operational standards that can be leveraged across multiple portfolio companies.

Associate Director, Clinical Supply

• Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites
• Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
• Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies
• Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites
• Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines
• Develop and cultivate strong site relationships and ensure continuity of site relationships
• Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance
• Identify, assess, escalate and resolve site performance or quality issues in a timely manner
• Complete feasibility and site identification activities for new clinical studies
• Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments)
• Facilitate communication with appropriate site staff involved in start-up and IRB/EC submissions
• Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance
• Responsible for the development of site specific recruitment, retention and follow-up plans
• Facilitate and support investigator site audits and/or inspection activities as needed
• Perform remote data review and query resolution for designated sites
• Contribute to overall clinical operations team knowledge by sharing best practices and participating in improvement initiatives
• Coach and mentor colleagues as needed
• Contribute to the review of Codera’s systems and procedures as needed
• May be involved, when needed, in other areas of study management and staff training
• Execute other duties as assigned

Clinical Research Associate – Site Director

• Provide scientific leadership and help execute the Global Medical Affairs strategy and tactical plan for civorebrutinib (EVER001)
• Develop and maintain deep scientific expertise in civorebrutinib, immune-mediated renal kidney diseases, the competitive landscape, emerging clinical data, and evolving standards of care.
• Lead the global KOL engagement strategy, including identification, prioritization, scientific exchange, and long-term relationship development with key opinion leaders, investigators, professional societies, and patient advocacy organizations.
• Oversee the planning, development, execution, and measurement of scientific engagement activities, including advisory boards, expert panels, investigator meetings, and other scientific forums.
• Partner with Scientific Communications to develop and execute scientific messaging, the Scientific Communication Platform (SCP), publication strategy, congress strategy, and medical education.
• Collaborate with Clinical Development to support the civorebrutinib clinical trial program, including investigator and site engagement, and medical support as needed.

Medical Director, Global Medical Affairs, Nephrology

• Analyze and understand the laboratory and clinical aspect of high complexity tests, as offered by Agendia, Inc.
• Select areas of tumor for molecular analyses, interpret immunohistochemical tests, and explain the clinical and pathological significance of interpretations.
• Conduct histopathologic examination of submitted specimens to assess their adequacy for testing and make recommendations when limited specimen is available.
• Provide interpretation of immunohistochemical (IHC) stains as needed.
• Review batch and instrument quality control IHC stains as needed.
• Participate in day-to-day operations, including sign-out of Agendia’s genomic assays.
• Provide expertise and assistance to technologists and technicians to resolve case issues.
• Serve as delegated Clinical Consultant when assigned by Senior Medical Director.
• Work closely with clinical and administrative staff to ensure the highest standards of turnaround time, quality, and customer service are maintained.
• Assist with management of the Pathology Report Data Entry process.
• Follow established policies, procedures, continuous quality improvement objectives, safety, environmental, and/or control standards.

Associate Medical Director

• Provide leadership, strategic direction, and day-to-day operational management of a 6-person MSL team
• Maintain an active field presence as the primary MSL for a dedicated territory
• Ensure the team is adequately staffed, trained, and clear on their roles in executing medical plans
• Execute all MSL activities ensuring high-quality scientific engagements with external experts and HCPs
• Establish a productive work environment by creating trust and respect within the MSL team
• Conduct regular field co-rides and 1:1s with direct reports for coaching and feedback
• Oversee operational logistics and manage day-to-day administrative team duties
• Drive recruitment activities for new MSLs and ensure on-boarding and training
• Collaborate with cross-functional teams to ensure integrated medical activities

Director, Medical Science Liaison – Plastics & Regenerative Medicine

• Recruiting, training, developing, and managing a team of high-performing MSLs
• Fostering a team culture of accountability and develop a proactive approach to growing skillsets
• Provide strategic direction for MSL development and execution of comprehensive territory medical plans that align with medical objectives
• Ensure high quality presentations and interactions through quantitative and qualitative MSL data tracking
• Be instrumental in internal training and communication. Knowledge sharing, including KOL and site profiling, and education both internally and externally will be a crucial area of responsibility
• Developing relationships with various healthcare professionals and providing them with credible, fair, balanced, scientific information about product development, research activities, and therapy(s)
• Be a significant source of balanced medical information for HCPs and will be skilled in issues management and addressing unsolicited questions about safety and potential off-label use of products based on available scientific data
• Expected to become and lead teams to become a therapeutic area and product expert. This will be evidenced by regular review of relevant literature and participation in scientific congresses and conferences, including therapeutic area training sessions, to establish and maintain an up-to-date knowledge base
• Assist in identifying potential investigators and research projects. This may include assistance with the investigator-sponsored trial process, sponsored study site identification, recruitment strategies, and collaboration with clinical operations

Senior Director, Regional Field Medical Science Liaison, West

• 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

Hospice Director – Clinical Services

• Create and execute clinical operational strategic plans in line with product strategy and resource allocation.
• Develop study feasibility, cost estimates, input into contracts, work/change orders and analyze tools and processes to support outsourcing efforts.
• Track clinical program study finances and monthly accruals and review/approve associated clinical site and vendor invoices.
• Build, develop and train internal staff and external vendors, structure department for enhancing efficiency, and create a highly engaged work environment for attracting and retaining highly qualified clinical operations professionals.
• Develop and ensure compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines.
• Oversee and maintain the relationships with Contract Research Organizations, vendors, and investigative sites.
• Participate on clinical operations and study team meetings.
• Maintain a high level of professional expertise through familiarity of clinical literature, knowledge of therapeutic area, current medical practice and pharmaceutical regulations.

Senior Manager/Director, Clinical Operations

• Clinical leader of one or more endocrinology programs, being integral to developing the clinical strategy and plans
• Member of global project team(s) and development sub team(s)
• Contribute as the Clinical Research expert to the conception and regular modifications of the Target Product Profile (TPP)
• Lead the development of the Clinical Development Plan (CDP) for each indication being pursued, using the TPP as guidance
• Define the scientific rationale and design captured in the Clinical Study Outline for each study in the CDP
• Lead the discussions and oversee the writing of the study synopsis, study protocol and its amendments
• Review or oversee the review of the data input in the EDC for events of interest or needing further investigation
• Provide senior-level medical monitoring and safety oversight in cooperation with pharmacovigilance
• Collaborate with other departments in all topics related to the conduct and analysis of clinical study results
• Use the findings and other analyses to contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings
• Support advisory boards, key opinion leader engagement, and external scientific collaborations
• Contribute to the development of relevant sections of regulatory documents such as amendments to protocols and responses to Health Authorities questions

Senior Medical Director, Clinical Research, Endocrinology

• Support the development and execution of Crinetics' endocrinology portfolio as part of a multidisciplinary development team
• Contribute to the concise clinical development plan (CCDP)
• Support the design and conduct of clinical trials across assigned therapeutic areas
• Provide medical and scientific input to publications
• Support Medical Affairs
• Help represent Crinetics to academic, regulatory, and patient organizations
• Partner with the cross-functional team to shape a concise Clinical Development Plan (CCDP) for the indication of interest, building consensus toward Executive Team approval and maintaining the plan over time
• Lead the design, planning and implementation of clinical trials consistent with this CCDP
• Provide scientific and clinical direction for the development of clinical protocols (and, in early stages, clinical trial outlines [CTOs] and synopses), amendments, and related documents (e.g., informed consent)
• Work with Medical Writing to ensure content accuracy and medical integrity
• Provide medical monitoring for clinical studies in collaboration with CRO medical monitors
• Ensure that clinical trials are conducted according to GCP and all applicable regulatory requirements
• Provide clinical and scientific input to HEOR-led Patient Reported Outcome research across the studies
• Provide medical and scientific oversight needed to support enrollment feasibility and protocol-driven eligibility
• Participate in ongoing and formal data analyses and review for CSR completion and planned/actual filing activities
• Contribute to the development of clinical sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND/BLA submission documents, responses to Health Authorities questions
• Lead trial-related advisory boards, investigator meetings, protocol training meetings
• Collaborate with Medical Affairs and Commercial members to develop effective working relationships with key investigators, key opinion leaders and patient advocates to optimize scientific quality/innovation of clinical study design, execution, reporting and publication
• Provide medical/clinical expertise to publications planning and drafting
• Provide oversight of clinical programs across planning, execution, and completion of clinical trials, ensuring compliance with all applicable regulations and guidance, ICH/GCP, and Crinetics SOPs, in partnership with Clinical Operations
• Attend conferences and remain current with relevant therapeutic area information
• Serve as the external clinical "face" of Crinetics in interactions with development partners, and leading clinical discussions at advisory boards, as needed.

Medical Director, Clinical Research, Endocrinology

• Identifying and maintaining a list of medical/therapeutic area experts, investigator targets and associated plans of action
• Establishing, fostering, cultivating and maintaining relationships with KOLs in Hematological Malignancies
• Act as the primary clinical/scientific resource for information pertaining to disease state and our products ensuring awareness and understanding
• Participates in the development and management of company sponsored clinical trials
• Establishing scientific relationships with investigators and internal Medical Affairs, supporting investigator-initiated study (IIS) concept program
• Identifying relevant insights on research developments, treatment landscape to shape medical strategy
• Identifies gaps in research needs and creates opportunities by collaborating with potential and existing investigators and site personnel
• Responds to requests for information related to study indications, disease state and therapeutic area, and presents/discusses scientific/clinical data
• Attend medical conferences collecting and reporting relevant, scientific, clinical, & competitive intelligence
• Ensures company policies, procedures, principles and financial controls are maintained with integrity and professionalism is displayed internally and externally

Associate Director, Field Medical Affairs – Hematology

• Serves as a primary source of medical accountability and oversight for multiple clinical trials.
• Manages Phase I/II studies, with demonstrated decision making capabilities.
• Provides medical and scientific expertise to cross-functional BMS colleagues.
• Maintains matrix management responsibilities across internal and external networks.
• Serves as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept.
• Articulating clinical development strategy.
• Analyzing, interpreting, and acting on clinical trial data to support development.
• Serving as principal functional author for Regulatory submission, study reports, and publications.
• Provides oversight and medical accountability for multiple trials across early development clinical lifecycle.
• Manages site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines).

Director, Global Clinical Physician – Early Clinical Development, Oncology

• Lead the complex, cross-functional efforts required to implement vertical strategy, demand generation, focusing on optimizing the growth of the Healthcare vertical.
• Spearhead new business initiatives both through direct sales via HBS and Partnerships through the channel.
• Lead the finance forecasting and reporting cycles in its entirety; manage the MOS, ensuring activity, pipeline, opportunities management, and order flow is tracking to target.
• Work closely with customers to co-create innovative Honeywell solutions that address their critical needs and most important challenges.
• Analyze customer behavior using data-driven insights to create compelling narratives that highlight how our solutions resolve their challenges.
• Identify and cultivate key vertical partnerships with external stakeholders, prepare functional and technical specifications collectively with Application Engineering.
• Closely monitor how the market landscape is evolving and adapt to changing conditions to best address growth opportunities.

Director of Sales, Building Automation – Healthcare

• Provide strategic and operational leadership for Kite’s auto immune portfolio, and pipeline assets in solid tumors
• Shape and execute global Medical Affairs strategy across the product lifecycle
• Ensure scientific excellence, patient‑centric decision‑making, and compliant engagement with the medical community
• Partner closely with Clinical Development, HEOR, Market Access, Government Affairs, Marketing, and regional Medical Affairs teams
• Play a critical part in evidence generation, insight capture, medical education, and launch readiness
• Translate science into real‑world impact for patients
• Provide oversight of the disease area budget, ensuring appropriate investment and resource stewardship

Senior Director, Global Medical Affairs – Auto Immune & Pipeline

• 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

• Provides strategic leadership in advancing pharmacy services through the integration of clinical quality, safety, and outcomes initiatives.
• Advances a culture of clinical excellence, patient safety, and continuous quality improvement within pharmacy services.
• Oversees the assessment, development, implementation, and evaluation of policies, procedures, and programs aimed at ensuring safe, evidence-based pharmacologic care across all healthcare settings.
• Provides oversight of the system drug diversion prevention, medication safety, medication use policy, and regulatory compliance and accreditation programs across the system.
• Serves as a key partner in institutional quality and safety initiatives and regulatory compliance.

Senior Director, Pharmacy Clinical Quality – Safety

• Serve as a senior thought partner to functional leaders, contributing to program-level planning, risk mitigation, and execution strategies.
• Collaborate across Clinical Operations, Biostatistics, Medical, Regulatory, Safety, and Quality to identify and resolve data-related issues impacting timelines, quality, or compliance
• Set up data management vendors as required, including authoring of RFPs, reviewing and negotiating data management budgets and contracts
• Oversee database status with respect to key performance indicators, metrics, and program level deliverables and timelines to support program timelines
• Oversee data review, cleaning, and database lock activities to ensure accuracy and readiness for analysis and regulatory submission
• Proactively identify vendor risks, escalate issues as needed, and drive root-cause analysis and corrective actions
• Balance quality, timelines, and cost while driving pragmatic solutions aligned with program priorities
• Foster a culture of accountability, collaboration, and continuous improvement across internal teams and external partners
• Provide direct supervision and periodic review of work for departmental employees, to ensure oversight and execution of clinical development timelines
• Direct and mentor a team of data management professionals.
• Foster a collaborative environment that encourages innovation and knowledge sharing.
• Ensure effective resource allocation and management across research departments.
• Drive performance and accountability through clear communication of expectations and goals
• Support organizational growth by scaling data management capabilities and processes as the portfolio evolves

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