Description
Medical Director, Diabetes is the medical leader contributing to the development and lifecycle management strategy across the disease state of diabetes mellitus (Type 1, Type 2, Gestational Diabetes) as well as the company products that address this condition. This executive role contributes to the design, execution, and strategic progression of development-stage and postmarketing clinical programs as well as leads the medical strategy for scientific exchange on the marketed products- ensuring scientific accuracy, strong clinical evidence, and alignment with the company’s corporate vision.
The Medical Director, alongside the TA Head, provides strategic leadership for Translational Medicine, Clinical Development, Clinical Operations, Biostatistics/Data Management, Medical Affairs, Drug Safety / Pharmacovigilance, and Regulatory Affairs to advance integrated development and lifecycle planning. The Medical Director also contributes to cross-functional scientific leadership and medical expertise to commercial and market access counterparts.
Therapeutic Area Leadership & Strategy
Advance clinical programs in diabetes (and associated disease states) integrating parenteral and pulmonary drug delivery strategies where relevant.
Synthesize scientific, clinical, regulatory, and competitive insights to guide pipeline prioritization, shape evidence strategies, and inform longrange portfolio and lifecycle planning.
Partner with the TA Head to provide direction for the lifecycle management strategy for the diabetes portfolio, ensuring alignment with MannKind’s scientific platforms, inhaledtherapeutic technologies, and longterm enterprise objectives.
Clinical Study Planning & Design
Spearhead the design and planning of Phase 1–4 clinical trials across diabetes and related indications, including dose selection, patient segmentation, biomarker strategy, and endpoint development.
Engage internal scientific leaders and external experts across endocrinology (and pediatrics) to refine study rationale, strengthen mechanistic understanding, and optimize development pathways.
Oversee advisory board strategy and insight generation to integrate crossdisciplinary perspectives and ensure study designs reflect realworld clinical practice and unmet need.
Ensure clinical protocols meet the highest standards of scientific integrity, operational feasibility, and regulatory alignment, supporting efficient execution and highquality evidence generation.
Clinical Study Execution & Oversight
Provide guidance to the execution of all diabetes clinical programs, supporting crossfunctional interfaces to ensure robust, efficient, and highquality delivery of evidence across early and latestage development.
Biostatistics & Data Management – Partner closely to ensure data integrity, statistical rigor, and highquality analyses that support regulatory submissions and scientific decisionmaking.
Safety / Pharmacovigilance – Contribute to the safety strategy, oversee safety surveillance, interpret emerging safety signals, and ensure comprehensive riskbenefit assessments throughout development.
Clinical Operations – Provide input into CRO and vendor oversight, operational planning, site engagement, and execution of global clinical studies.
Ensure all studies adhere to FDA, EMA, and global regulatory requirements, including GCP, ethical standards, and inspection readiness.
Maintain accountability for medical monitoring, serving directly as the medical monitor or by providing leadership and oversight to delegated medical monitors.
Regulatory Leadership & Scientific Communication
Drive regulatory strategy and submission development for the diabetes portfolio, including INDs, NDAs/BLAs, briefing documents, clinical study reports, and responses to regulatory agencies.
Represent the therapeutic area in FDA, EMA, and global regulatory interactions, ensuring teams are fully prepared for meetings, advisory committees, inspections, and crossagency engagements.
Contribute to the development, review, and approval of all key scientific and regulatory documents, including clinical protocols, CSRs, investigator brochures, and internal or external scientific communications.
Medical Affairs Collaboration
Provide content leadership to Medical Affairs to shape scientific platforms, diseasearea lexicons, and evidence strategies across endocrinology conditions.
Ensure alignment between clinical development strategy and fieldbased medical strategy, driving consistent non-promotional scientific messaging across medical/clinical and payor audiences.
Support publication planning and scientific communication, ensuring clarity, accuracy, and cohesion across the evolving evidence base.
Data Analysis, Interpretation & Strategic Insight Integration
Guide the analysis, interpretation, and communication of clinical data across diabetes and pediatric expert audiences, ensuring scientific rigor and strategic clarity.
Synthesize emerging scientific, clinical, and competitive insights to refine development strategy, inform evidencegeneration plans, and adapt to evolving scientific trends.
Provide strategic recommendations to executive leadership based on trial learnings, external landscape shifts, and evolving therapeutic opportunities.
CrossFunctional Leadership & Enterprise Influence
Partner with Commercial, Market Access, and Business Development to ensure clinical evidence supports market needs, access strategies, and differentiated product positioning.
Support diligence activities for potential inlicensing, collaborations, or partnerships for diabetes and/or related systemic disease areas.
Serve as a key contributor within enterprise governance, providing therapeutic area expertise to inform pipeline investments, milestone decisions, and portfolio prioritization.
People Leadership & Organizational Development
Mentor medical colleagues and cultivate an organizational culture grounded in scientific excellence, accountability, transparency, and crossfunctional collaboration.
Requirements
Education: M.D. required, with clinical experience in medical practice preferred, ideally as a diabetologist/endocrinologist. An additional PhD, MPH, or MBA also highly valued.
Experience: 10+ years of progressive medical affairs and/or clinical development experience within the pharmaceutical or biotechnology industry. Demonstrated expertise in diabetes (and additional experience in pediatric endocrinology and/or maternal-fetal medicine preferred). Proven ability to lead and influence crossfunctional teams, collaborate effectively with investigators and scientific leaders, and represent programs in global interactions. Exceptional scientific communication, analytical, and leadership capabilities, with the ability to convey complex clinical concepts to diverse internal and external stakeholders. Ability and willingness to travel approximately 20%, primarily domestically, with occasional international travel.
Industry Knowledge: Deep understanding of clinical development methodologies and lifecycle management strategies
Knowledge of U.S. (and exU.S.) regulatory and clinical research requirements relevant to diabetes drug development.
Demonstrated ability to integrate scientific insights, regulatory expectations, competitive intelligence, and operational considerations into cohesive, forwardlooking development strategies.