Medical Director

• 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

• 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

• 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

• Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for asset(s) in development
• Ensuring alignment with and support of project strategic plans, regulatory requirements, and commercial goals, optimizing clinical study design aligned with IEP and CDP
• Generating the data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation, and value to patients.
• Providing effective support and oversight of evidence generation activities to assure patient safety and study delivery.
• Enabling robust protocol design, including selection of clinical endpoints, patient populations, and participant monitoring strategy
• Working with Clinical Operations and Biostatics to deliver clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP
• Active medical monitoring activities and medical data review of ongoing studies, including: Lead, coordinate activities and present at IDMCs, adjudication committees, ongoing routine safety review
• Interpretation and presentation of clinical data for clinical study reports and publications
• Oversee and train study team on protocol-related activities in collaboration with matrix study team members
• Developing and maintaining relationships with program counterparts, including Commercial, Research, Regulatory, Clinical Operations, and Statistics
• Interfacing and influencing a diverse range of scientific external experts (e.g., regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs, align to business strategy, and address patient needs.
• Gathering and supporting the integration of inputs from across disciplines (scientific, clinical, commercial, regulatory) to contribute to clinical components of the Medicine Profile
• Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses
• Serving as a clinical representative for senior management and senior level matrix teams, both internally and externally for an asset in development
• Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in RIIRU
• Supporting technical and leadership development of RIIRU staff via mentoring and coaching for matrix team members
• Support enterprise efforts to streamline and grow efficiencies for the business unit

Medical Director, Clinical Development, Immunology

• Serves as a primary source of medical accountability and oversight for clinical trials
• Manages Phase 1 – Phase 3 studies, with demonstrated decision making capabilities
• Provides medical and scientific expertise to cross-functional BMS colleagues
• Provides ongoing medical education in partnership with CS to allow for protocol-specific training, supporting the study team, investigators, and others
• Contributes to key Health Authority interactions and advisory board meetings as Associate Director, Global Medical Monitoring
• Conducts medical data review of trial data, including eligibility review
• Holds responsibility for site interactions in partnership with the Global Clinical Scientist (CS) for medical questions and education (including safety management guidelines)
• Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
• Collaborates with CS and inputs into protocols, providing medical strategic oversight in protocol development

Associate Director, Global Clinical Physician – Neuropsychiatry

• Provide accountability and primary oversight of the execution of multiple portfolio assets
• Lead activities from clinical perspective and ensure successful management of development aspects of our marketed assets
• Deliver scientific leadership across trial level DU activities in partnership with various functions.
• Represent Biogen in external collaborations and events as relates to these assets (such as Regulatory discussions and scientific meetings)
• Act as the DU representative in business development activities if required

Executive Medical Director, Clinical Development, MS and Neuropsychiatry

• Provides strategic medical and scientific knowledge (Cardiovascular, Renal, Metabolic, and/or Liver Disease) and supports the design, initiation, execution, completion, and interpretation of a clinical study
• Is accountable for study designs
• Is accountable to deliver medical information, answers, and clarifications to Regulators, Ethic Committees, Marketing Companies, Investigators/Sites
• Often works as a Global Clinical Head (GCH) delegate across several studies (e.g. a paediatric programme, or a set of mechanistic/differentiating studies)
• Can be the clinical representative on indication Global Product Teams and/or other sub-teams
• Has the knowledge to work across projects, with a fast learning curve when moving into new disease area
• Is accountable to the Global Clinical Head (GCH) or delegate for the medical aspects and designs of studies
• Is responsible for driving decisions within Study Team (ST) remits together with other ST members and for solving medical issues in the study team
• Is accountable for the medical and ethical components of studies including patient safety on a study level in compliance with GCP
• Is accountable for delivery of the clinical components of all relevant study documents (e.g Protocol, Amendments, Statistical Analysis Plan, Informed Consent Form, Case Report Forms, and Safety and Risk-Based Monitoring Plans)
• Is accountable for ensuring that safety surveillance on a study level including the process for Adverse Events (AE)/ Serious AE reporting, the querying of missing/unclear data, the review of blinded safety data, and the escalation to the GCH/Global Safety Physician when needed.
• Is medically accountable for international investigator meetings, and supports Marketing Companies (MC) in national activities
• Approves (with the GCH) the Clinical Study Report; including preparation and production thereof (Introduction, Results, Discussion).
• Is accountable for ST induction and education of new members in the study team, as well as others involved in the study
• Collaborates seamlessly and efficiently with global colleagues at other R&D sites
• May be accountable to GCH (or delegate) and leadership for identifying risks and proposing mitigation strategies to deliver successful Phase II, III, IV or Life Cycle Management studies
• Stays updated on relevant scientific literature
• Delivers analyses of clinical data in a balanced, statistically sound fashion, to drive interpretations and further idea generation
• Serves as a source of medical expertise for the Product Team, in analyses and interpretation of medical data
• Maintains a high degree of understanding and awareness on new and emerging medical development, globally.
• Works with international colleagues and with external Alliance partners on development initiatives and regulatory issues
• Applies strategic intent of AstraZeneca when working with Alliance partners, Regulatory Authorities, payers, opinion leaders, prescribers and consumers of AstraZeneca products
• Able to provide guidance for investigator-initiated trials in cooperation with regional marketing companies
• Accountable for building trustworthy relationships with steering committees/executive committees with AROs/CROs
• Maintains strong networks globally with KEEs, prescribers, regulators and payers

Senior Director, Global Clinical Program Lead

• 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

• Guide teams in content development and medical strategy
• Provide strategic input into account planning
• Build and nurture client relationships
• Identify business development opportunities
• Lead strategy execution in collaboration with teams
• Facilitate meetings and workshops

Associate Medical Strategy Director

• Coach, train and manage MSL performance and development to ensure excellence in the execution of the role
• Co-create/develop TA Medical Plans and lead team execution to ensure alignment to medical priorities
• Monitor individual and team progress against medical and business priorities
• Lead internal collaboration around insights generation activities and ensure data, facts and observations are gathered, reviewed and analyzed

Field Medical Director, Oncology

• Lead the design of clinical trials by developing study protocols and selecting endpoints
• Provide strategic oversight for clinical trial execution and monitor study progress
• Drive the creation of key study-level documents such as protocols and regulatory submissions
• Address regulatory/health authority inquiries and ensure compliance with guidelines
• Develop and oversee the Clinical Development Plan and Integrated Evidence Plan
• Collaborate with cross-functional teams to ensure seamless execution of clinical development programs
• Mentor junior team members within the clinical science organization

Director, Clinical Science

• Establishes or adapts clinical development plan for the program(s) including discussions with clinical investigators, advisors and regulatory authorities and plans contingencies.
• Leads, supports and oversees the execution of clinical development and studies activities, including but not limiting to: Authors abbreviated protocol.
• Reviews the final protocol and protocol amendments.
• Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form.
• Reviews the study specific committee charters.
• Leads study specific committees with operational support.
• Leads the clinical interpretation of study results, contributes to clinical study reports and clinical summaries.
• Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine
• Participates and contributes to regulatory and safety documents and discussions
• Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans
• Contributes to the clinical sections of the NDA/CTD, Briefing packages for regulatory meetings, PSP/PIP
• Participates in Advisory Committee preparation
• Scientific data evaluation and authorship
• Authors clinical abstracts, presentations for conferences, and manuscripts, when appropriate
• Supports the planning of advisory board meeting. Presents and discusses development strategy and clinical study result with external investigators and advisory boards, as appropriate

Clinical Research Director

• Represent non-clinical safety as a Project Team Member, providing strategic input to integrated project plans
• Lead or contribute to the design, coordination and delivery of optimized non-clinical safety and translational project plans
• Integrate scientific data and knowledge into clear, evidence-based narratives for internal governance
• Provide expert consultancy on target liabilities, candidate selection, safety screening, due diligence opportunities
• Influence cross-functional stakeholders through high-quality scientific judgement, communication, negotiation and decision support
• Support capability and quality across the PTM community through coaching, mentoring, training, peer review and approval of key internal and regulatory documents
• Contribute to regulatory strategy and lead or support global regulatory submissions

Senior Director – Non-Clinical Safety Project Specialist

• Supervision and Consultation
• Participate in the weekly Clinic Director meeting
• Provide weekly individual supervision and bi-weekly group supervision for master's level clinicians seeking licensure
• Provide 1:1 consultation staff to review productivity, caseload, and clinical documentation
• Administrative Troubleshoot issues within Valant and billing
• Support clinic staff development
• Partner with CD to support administrative changes as needed
• Coordinate with CD to support the hiring process
• Coordinate office supply orders with Clinic Director
• Assist CD with monitoring and managing clinic office schedules
• Provide timely response to concerns raised by clients and clinicians
• Maintain agreed upon clinical client caseload
• Serve as back-up for CD when they are out of the office
• Additional duties as assigned

Assistant Clinical Director

• Support the Clinic Director in the oversight of performance and operations of the clinic
• Provide weekly individual supervision and bi-weekly group supervision for master's level clinicians seeking licensure
• Assist with staffing needs, provide resource support, and perform administrative oversight
• Troubleshoot issues within Valant and billing
• Support clinic staff development
• Coordinate with CD to support the hiring process
• Assist CD with monitoring and managing clinic office schedules
• Provide timely response to concerns raised by clients and clinicians
• Maintain agreed upon clinical client caseload

• Design and implement a global Clinical Technology Vendor Governance Framework aligned with ICH GCP E6 R3 and regulatory standards.
• Oversee day-to-day vendor performance for technologies like EDC, eCOA, RTSM, eTMF, RBM, digital health solutions, and AI-driven systems.
• Define KPIs, SLAs, and metrics tied to study timelines, data quality, system performance, and delivery reliability.
• Establish robust AI governance frameworks ensuring transparency in intended use, decision boundaries, risk classification, validation processes, and lifecycle management.
• Proactively manage risks through monitoring systems while maintaining inspection readiness for regulatory audits.
• Serve as the central escalation point for issue resolution across internal teams and external vendors.
• Drive strategic oversight of technology vendors to optimize scalability and cost-efficiency while fostering trust-based partnerships.

Director, Clinical Technology Oversight Lead

• Responsible for the development and execution of the clinical development plan and has ownership for the design of clinical trials and for the content of clinical study reports
• Leads Cross-functional Clinical Team; supervises, develops and recruits junior medical staff
• Molecule responsible physician; Responsible for the oversite of medical monitoring/reporting and safety activities; Evaluates adverse events (pre and post-marketing) for relationship to treatment.
• Responsible for overseeing content for the Independent Data Monitoring Committee (IDMC) and adjudication meetings as needed
• Interprets, reports and prepares results of product research in preparation for global health authority submissions and external communication
• Responsible for assessment of medical publications emerging from the Team and its affiliates
• Assists Regulatory Affairs in the development of drug/device regulatory strategies and determining requirements for any corrective actions or health authority reporting
• Acts as medical contact at company for global health authorities concerning clinical/medical issues
• May act as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committees
• Helps explore and evaluate new product ideas to assist in identifying new marketing opportunities
• Supports general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance
• Supports early clinical development involving product potential and development for registration
• Manages the budget for all project related clinical activities

Medical Director jobs in Massachusetts

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Director of Ancillary, Clinical Systems

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

Associate Director, Clinical Supply

Associate Director, Clinical Science

Senior Director, Medical Writing

Medical Director, Clinical Development, Immunology

Associate Director, Global Clinical Physician – Neuropsychiatry

Executive Medical Director, Clinical Development, MS and Neuropsychiatry

Senior Director, Global Clinical Program Lead

Director, Global Clinical Physician – Early Clinical Development, Oncology

Associate Medical Strategy Director

Field Medical Director, Oncology

Director, Clinical Science

Clinical Research Director

Senior Director – Non-Clinical Safety Project Specialist

Assistant Clinical Director

Assistant Clinical Director

Director, Clinical Technology Oversight Lead

Executive Director, Clinical Leader – Neuropsychiatry

Executive Director, Clinical Leader – Neuropsychiatry