Medical Director

• Act as the primary IT point of contact for Commercial and Medical Affairs leadership, developing strong, trust-based partnerships
• Understand the Commercial and Medical Affairs strategy, business goals, and operational challenges, aligning business objectives to clear, prioritized IT initiatives and requirements
• Support systems and new product introduction by providing technical expertise, system administration, problem solving, and strategies for risk mitigation
• Support the overall governance and lifecycle management of commercial and Medical Affairs systems and platforms. (e.g., Veeva Vault CRM, Open Data, Link, Approved Email)
• Lead requirements gathering, documentation, and testing for commercial and Medical Affairs platforms. Ensure configuration, enhancement, and expansion of the systems aligns with broader organizational data standards, information security practices, and regulatory needs
• Work closely with IT and Legal to ensure data protection controls such as segmentation and access boundaries are designed, implemented, and consistently enforced in alignment with regulatory requirements
• Ensure alignment between business demand and IT capacity and prioritization
• Provide oversight and system administration across SaaS platforms supporting Commercial operations and Medical Affairs. (e.g., CRM, field enablement, analytics, content management)
• Ensure solutions are scalable, user-centric, and aligned with enterprise architecture standards
• Monitor delivery risks, dependencies, and change impacts; escalate as appropriate
• Serve as a clear communicator between technical and non-technical stakeholders
• Drive change management, user adoption, and ongoing optimization of deployed solutions.
• Note that this is a hands-on role. A successful candidate will be expected to execute all above requirements with minimal assistance from staff.

Director, IT System Business Partner – Commercial and Medical

• Serve as the primary business owner and day-to-day point of contact for the company's outsourced Medical Information Contact Center (MICC) vendor.
• Responsible for operational oversight, governance, and performance management of the vendor relationship.
• Ensure that medical inquiries, scientific response letter (SRL) fulfillment, adverse event (AE) intake, and product quality complaint (PQC) intake are handled accurately and compliantly.
• Monitor vendor performance against contractual key performance indicators (KPIs) and service level agreements (SLAs).
• Oversee onboarding, ongoing training, and product/process knowledge transfer for vendor staff.
• Ensure accurate recognition, documentation, and timely transfer of adverse event (AE) reports to the Pharmacovigilance/Safety function.

Associate Director - Medical Information, Pharmacovigilance Contact Center Operations

• 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 clinical direction, oversight, and support to assigned facilities across the region.
• Lead clinical teams in the delivery of safe, ethical, evidence-based, and compliant behavioral health services.
• Develop clear role expectations for Clinical Directors and clinical team members.
• Provide leadership, coaching, and support to facility Clinical Directors
• Develop effective meeting structures for clinical leadership, including bi-weekly virtual individual meetings with Clinical Directors and group meetings as needed.
• Build strong working relationships with facility Clinical Directors, Executive Directors, clinical staff, and corporate leadership.
• Report clinical trends, risks, barriers, and operational updates to the supervisor.
• Ensure clinical services are delivered in accordance with local, state, and federal regulations, Joint Commission accreditation standards, company policies, and payer expectations.
• Support implementation of policies and procedures consistent with ASAM criteria and organizational best practices.
• Monitor clinical compliance, quality of care, documentation accuracy, treatment planning, discharge planning, and patient engagement.
• Establish and maintain clinical quality systems to ensure clients receive care consistent with program expectations, clinical standards, and the client handbook.
• Conduct frequent clinical quality visits to all assigned treatment centers, at least monthly or more often as needed.
• Support survey preparedness and provide on-site leadership during regulatory or accreditation surveys when needed.
• Assist with mock surveys, state surveys, Joint Commission surveys, Plans of Correction, and corrective action follow-up.
• Monitor implementation and completion of Plans of Correction related to clinical services.
• Ensure timely, complete, and compliant medical record documentation.
• Develop and monitor clinical reporting tools, including weekly clinical reports for Clinical Directors and chart audit processes for Executive Directors and Regional Directors.
• Establish, implement, and monitor submission processes for required clinical reports and audits.
• Identify documentation concerns and escalate repeated or serious performance issues through the appropriate leadership and human resources processes.
• Support successful clinical operations across assigned facilities.
• Assist with clinical system implementation during acquisitions, new facility openings, or operational transitions.
• Review requests for administrative discharge and provide clinical guidance prior to final disposition.
• Provide pre-admission clinical reviews as needed.
• Support clinical assessment processes, client sessions, and direct care needs when necessary.
• Communicate needed changes and assist with implementation of clinical improvement goals.
• Serve as a resource regarding clinical issues, addiction treatment trends, mental health treatment trends, regulatory expectations, and clinical best practices.
• Collaborate with operations, quality, compliance, nursing, medical, admissions, utilization review, and human resources teams to improve clinical performance.
• Provide regular education, onboarding, and orientation to Clinical Directors and clinical staff.
• Develop and deliver clinical training to support documentation quality, ASAM alignment, therapeutic standards, regulatory compliance, and evidence-based care.
• Provide in-service education for staff as requested.
• Work with Service Excellence to develop and implement clinical staff training and professional development initiatives.
• Assist with recruitment, interviewing, hiring, and onboarding of qualified Clinical Directors, therapists, and other clinical team members.
• Support professional growth, accountability, and leadership development across the clinical team.
• Be available to support facility leadership when significant clinical events, regulatory concerns, safety issues, or urgent operational needs occur.
• Provide clinical consultation and leadership during critical incidents, adverse events, patient safety concerns, and high-risk discharges.
• Ensure appropriate follow-up, documentation, communication, and corrective action after clinical events.

Regional Director – Clinical Quality

• Advise the CEO and executive team on clinical strategy, care model evolution, and external positioning
• Build the Abby Care clinical narrative across pediatrics, adult home health, and senior care, translating the model into language that resonates with plan CMOs, state officials, and clinical audiences
• Serve as the external clinical face of Abby Care with payors, health systems, state regulators, and industry bodies
• Own the evidence strategy: partner with analytics and clinical operations to design the outcomes program, then publish results through whitepapers, peer-reviewed work, and industry venues
• Represent Abby Care at conferences, roundtables, and advisory forums; build the speaking, media, and thought leadership platform

Chief Medical Officer

• 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 the Center for Geroscience & Healthy Aging (CGHA).
• Establish and scale the CGHA as a flagship enterprise for healthy aging—creating programs that advance research, clinical care, and innovation.
• Set the CGHA strategy and execution plan across discovery, translation, and implementation.
• Recruit, retain, and mentor basic, translational, clinical, and population scientists.
• Promote inclusive excellence in recruitment, retention, mentorship, and advancement.

Tenured Professor – Geriatrics and Palliative Care Medicine, Director of Center for Geroscience and Healthy Aging

• Acts as medical expert and leader in interactions with external collaborators (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal collaborators (e.g., Research, Early Clinical Development, Global Medical Affairs, Marketing, HEOR), and internal decision boards
• Uses excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions; uses that creativity and knowledge to build and defend data-driven plans and decisions, both with internal scientific management and the Company's partners/collaborators
• Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape; designs and develops smaller, yet robust and innovative FIH as well as Phase 2/3 programs
• Drives strong consensus-building skills and the ability to lead multi-disciplinary teams towards sound decision-making; leads dynamic and matrixed clinical teams in a fast-paced and hands-on environment
• Leads and develops a team of MDs and clinical scientists to meet business needs

Executive Medical Director, Clinical Program Lead, Immunology / Rheumatology

• Provide day-to-day leadership and supervision of the Clinical Education team (regional nurse educators, simulation staff, education design personnel).
• Oversee statewide, site-type-specific training curricula implementation across enrolled facilities.
• Ensure training delivery timelines, onboarding milestones, and quality standards are met consistently.
• Maintain curriculum fidelity and instructor competency in collaboration with Hub clinical leadership and simulation faculty.
• Direct deployment of regional educators across regions.
• Oversee site readiness assessments, onsite training events, drills, structured debriefings, and competency refreshers.
• Collaborate with clinical faculty and education design staff to develop and maintain obstetric emergency curricula for ED, EMS, outpatient, and birthing hospital settings.
• Manage program budgets for training delivery, equipment, and operations.
• Collaborate with the Evaluation Director and data team to ensure timely collection of training and readiness data.

Clinical Education Program Director

• Drive sales growth for New Product Launches.
• Achieve contract receipt targets.
• Develop and implement innovative sales strategies.
• Work with Beta Customers and product owners to develop expected ROI norms.
• Identify opportunities and assist in closing deals efficiently.
• Collaborate with the sales team to execute effective sales campaigns.

Director, New Product Go-To-Market – Healthcare Technology

• Ensure timely completion of all medical appointments, including new patient induction, follow-ups, medical histories, and laboratory testing.
• Review laboratory results and medical documentation from other providers, managing patient care according to best practices.
• Ensure medical providers prescribe and titrate medication-assisted treatment appropriately.
• Ensure patients receive adequate services for communicable diseases, including risk evaluation, testing, and counseling.
• Conduct chart and dashboard reviews to ensure adherence to medical policies.

• The Medical Director is responsible for developing and sustaining relationships and impacting clinical strategies and workflows that promote practice and patient satisfaction and improve value-based healthcare delivery.
• This role will inflect and implement Aledade's programs and technologies and learn what really "moves the needle" in terms of delivering quality health outcomes while reducing overall cost for the assigned ACOs.
• This role requires demonstrated excellence in creating buy-in with internal and external stakeholders to promote and affect change in the way healthcare is delivered.

Medical Director – Hospitals & Health Systems

• Lead the early phase clinical development of compounds from first-in-human studies through proof-of-concept
• Collaborate on teams to support the design and delivery of early phase clinical trials
• Support protocol development, study start up, data review, monitoring and analysis activities
• Contribute to the design and implementation of the early clinical development strategy for cardiometabolic/general medicine therapeutic candidates
• Contribute to the preparation of clinical development plans, clinical study protocols, informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions
• Review and evaluate clinical study safety, efficacy, pharmacodynamic and pharmacokinetic data
• Contribute to the strategy and use of clinical biomarkers to facilitate drug development
• Actively collaborate with Amgen Precision Medicine, Research, Late Development, Regulatory, Safety and Commercial colleagues
• Contribute to the evaluation of external licensing or partnering opportunities within the cardiometabolic/general medicine therapeutic areas
• Collaborate with external experts to provide biomedical expertise and strategic guidance to cardiometabolic/general medicine Early Development teams

Clinical Development Director – Early Development, Cardiometabolic/General Medicine

• Within Field Medical Affairs (FMA), has primary responsibility for directing clinical engagement efforts and developing/implementing medical account strategies on behalf of NNI among identified strategic and priority Managed Markets accounts
• Provides evidence-based scientific information for NNI products to executive decision makers, thought leaders, and business influencers
• Responsible for managing multiple internal relationships (mainly Market Access, Medical Operations, HEOR, and Medical Affairs)
• Acts as a scientific resource for health care providers (HCPs) and other NNI employees as required
• Attends and presents at assigned medical and scientific meetings
• Works collaboratively with the Senior Management of Managed Markets, HEOR, and Medical Affairs to identify, manage, and coordinate medical support needs at key MM accounts

Medical Account Director – National Account

• 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

• Support the design and implementation of early and late-stage clinical projects and ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous
• Develop and maintain clinical development plans that integrate preclinical, translational, and clinical data while ensuring alignment across cross-functional teams
• Design scientifically rigorous, operationally feasible, and cost-effective clinical protocols aligned with the overall clinical development plan
• Present clinical protocols, development plans, and study updates to internal governance committees and senior leadership
• Serve as the Clinical Science representative on cross-functional project teams
• Partner closely with the Medical Monitor to oversee study conduct, monitor study progress, and ensure protocol compliance
• Lead data review, evaluation, and analyses in collaboration with Data Management and Biostatistics and Statistical Programming teams
• Contribute to the preparation of clinical sections of regulatory submissions and supporting documents, including INDs, briefing documents, BLAs, Safety and Annual reports, and responses to regulatory agencies regarding questions about clinical development issues (e.g., safety or efficacy)
• Ensure compliance with applicable regulations, clinical R&D policies, SOPs and quality standards
• Support scientific due diligence activities, including preparing and presenting medically-sound strategies and plans associated with advanced opportunities
• Drive continuous improvement to enhance Clinical Development processes, study execution and cross-functional collaboration

Associate Director, Clinical Science

• Author and lead the development of core regulatory and clinical documents across all programs, including clinical study protocols (Phase 1–3), clinical study reports (ICH E3), investigator's brochures, regulatory agency briefing documents (FDA Type C/D, EOP2, PreIND), scientific advice packages (e.g., MHRA, EMA), and pediatric plans (PIP/iPSP)
• Own the narrative strategy for each document — not just execution — ensuring scientific accuracy, internal consistency, and alignment with the program's development strategy
• Author and edit IND/NDA/eCTD supporting documents including CTD Module 2/5 summaries, integrated summaries of safety and efficacy, and submission-ready clinical overviews as programs advance
• Establish and maintain documentation standards, templates, and best practices consistent with internal and external guidelines for regulatory documentation and submissions; drive innovative solutions to resolve issues
• Review regulatory, clinical, and safety documentation according to good documentation practices — evaluating organization, clarity, and scientific standards — to ensure consistency of content across the portfolio and compliance with worldwide regulatory requirements
• Support preparation of manuscripts and abstracts for peer-reviewed publications in collaboration with medical and clinical teams
• Build and maintain Agomab's medical writing template library, style guide, and standard operating procedures, ensuring documents are inspection-ready and submission-quality
• Serve as process owner and subject matter expert for regulatory documentation; lead the development of training and resources for writers and cross-functional partners regardless of reporting relationship
• Maintain current awareness of applicable regulatory guidelines (ICH E3, E6, E8, E9; FDA and EMA guidance; CTD/eCTD specifications; global disclosure requirements) and proactively apply updates to documentation standards
• Ensure consistent entry of data to support departmental metrics and analytics; define and track KPIs to evaluate impact on cycle time, quality, and operational efficiency
• Interface across multiple functions to influence regulatory documentation processes, mediate conflict resolution, and champion a culture that promotes meaningful collaboration and superior document quality
• Serve as the internal anchor and quality steward for all CRO medical writing engagements — select, brief, oversee, and review work from external writers
• Assess resource requirements across all projects; assign resources according to R&D priorities; prepare criteria and strategies for selection and management of external documentation support
• Establish quality standards, style guides, and review processes that apply consistently across internal and CRO-authored documents
• Manage timelines and deliverables for CRO medical writing workstreams, ensuring integration with program milestones and regulatory submission schedules
• Lead identification and implementation of AI-enabled use cases within Agomab — including draft generation, summarization, review support, and document comparison — while maintaining quality and compliance standards
• Establish and maintain responsible AI oversight, including risk management, validation approaches, and alignment with regulatory expectations
• Drive development of prompt libraries, reusable workflows, and training approaches to enable adoption across the organization
• Work comfortably with collaborative review platforms; bring experience or a clear point of view on which tools best serve a lean biotech environment
• Collaborate closely with Regulatory Affairs, Clinical Development, Clinical Operations, Biostatistics, and Pharmacovigilance and other stakeholders to gather inputs, coordinate review cycles, and drive documents to completion on time
• Participate in program team meetings; contribute to regulatory strategy discussions by providing a medical writing perspective on document feasibility and timeline planning
• Work with Project Management to establish and maintain document planning triggers, lead times, and milestone-based scheduling for all clinical documents across the portfolio
• Develop and maintain document storyboards, writing kick-off guides, and integrated planning tools that support cross-functional alignment before drafting begins
• Contribute to the development of the Medical Writing function — including resourcing models, capacity planning, and the transition toward a dedicated internal function supporting multiple programs

Senior Director, Medical Writing

• Provide physician leadership in the development, implementation, and ongoing evaluation of evidence-based clinical guidelines, medical policies, and utilization management protocols to support high-quality, clinically appropriate decision-making.
• Ensure clinical programs, utilization review activities, and medical management processes align with current standards of care, evidence-based medicine, accreditation requirements, and applicable federal and state regulations.
• Serve as the clinical authority for complex, high-risk, or escalated utilization review cases by providing medical expertise, benefit interpretation, and final medical necessity determinations as appropriate.
• Promote consistency, accuracy, and defensibility in medical decision-making by applying sound clinical judgment and established medical necessity criteria across all review activities.
• Collaborate with Clinical Operations, Compliance, Legal, and executive leadership to develop, review, and revise clinical and administrative policies, medical necessity guidelines, and benefit interpretation criteria.
• Monitor changes in clinical practice guidelines, healthcare regulations, payer requirements, and industry best practices, recommending updates to organizational policies and review processes as necessary.
• Provide physician oversight for quality and performance initiatives by reviewing medical management outcomes, analyzing quality metrics, and participating in quarterly Quality Committee meetings and reporting.
• Participate in internal audits, accreditation activities, regulatory reviews, and quality improvement initiatives to ensure compliance with organizational standards and continuous operational excellence.
• Partner with operational leadership to ensure clinical standards are effectively integrated into utilization review workflows, promoting efficient, evidence-based, and member-focused medical management.
• Provide clinical consultation and recommendations regarding post-service medical necessity determinations, appeals, and other medically complex cases requiring physician review.
• Serve as a trusted clinical resource and advisor to physicians, nurses, utilization review staff, and cross-functional business partners by providing education, guidance, and consultation on medical policy and clinical best practices.
• Participate in interdisciplinary committees, physician advisory groups, and organizational meetings to provide clinical insight and support strategic initiatives.
• Foster collaborative relationships with internal and external stakeholders to promote quality outcomes, regulatory compliance, and continuous improvement across medical management programs.
• Perform other duties as assigned.

Medical Director – Part Time

• Supports the development and execution of medical affairs strategies, programs, and deliverables.
• Provides clinical and subject-matter expertise to marketing and sales teams.
• Ensures the scientific integrity of research and communications with healthcare providers.
• Identifies, develops, and maintains productive relationships with thought leaders and stakeholders.
• Develops and executes Medical Affairs strategic scientific programs.

Senior Director, Medical Affairs

• Assessing the medical safety of assigned Janssen products
• Work closely with an experienced Medical Safety Officer to strategically lead cross-functional matrix teams responsible for product safety and benefit risk oversight
• Ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles
• Communicate potential and known risks and changes to benefit/risk to relevant stakeholders
• Lead in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Janssen products

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