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Accelerate Therapy &Amp

16 jobs near Columbus, OH

Edgewise Therapeutics

MH

Medical Oversight amp; Scientific Leadership * Serve as sponsor medical monitor for cardiovascular ... accelerate and expand their pipeline. In terms of the performance and personal competencies ...

Executive Director/Vice President - Therapy Area Head- Cardiorenal

MannKind Corporation

Bedford, MA

$224K - $396K/yr

Full-time

Posted 23 days ago

Job description

MannKind
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. With a focus on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, pulmonary fibrosis, nontuberculous mycobacterial (NTM) lung disease, and fluid overload associated with heart failure and chronic kidney disease.
MannKind’s core technologies, including ultrafine dry‑powder formulations and advanced inhalation platforms, enable rapid, convenient delivery of medicines directly to the deep lung. This approach supports both local pulmonary targeting and systemic delivery for various medical indications. Through alternative drug formulations and delivery mechanisms, MannKind aims to bring forward differentiated, patient‑centric therapies that expand treatment options to improve outcomes across chronic and rare diseases.
At MannKind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives.
Position Summary
The Therapy Area Head (TAH), Cardiorenal is the medical leader responsible for the clinical development strategy across the disease states of heart failure and fluid overload 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 TAH 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 TAH also provides cross-functional scientific leadership and medical expertise to commercial and market access counterparts.
Key Responsibilities:

Therapeutic Area Leadership amp; Strategy
  • Advance clinical programs across Cardiorenal disorders, and associated chronic disease pathways, integrating parenteral and pulmonary drug delivery strategies where relevant.
  • Serve as the senior clinical authority for Cardiorenal drug development, representing the therapeutic area across executive, governance, and strategic decision‑making forums.
  • Synthesize scientific, clinical, regulatory, and competitive insights to guide pipeline prioritization, shape evidence strategies, and inform long‑range portfolio and lifecycle planning.
  • (Define and) Partner with the CMO to lead the clinical development strategy for the heart failure portfolio, ensuring alignment with MannKind’s scientific platforms, inhaled‑therapeutic technologies, and long‑term enterprise objectives.
Clinical Study Planning amp; Design
  • Lead the design and planning of Phase 1–4 clinical trials across cardiorenal and related chronic disease indications, including dose selection, patient segmentation, biomarker strategy, and endpoint development.
  • Engage internal scientific leaders and external experts across cardiology, nephrology, critical care, and related specialties to refine study rationale, strengthen mechanistic understanding, and optimize development pathways.
  • Oversee advisory board strategy and insight generation to integrate cross‑disciplinary perspectives and ensure study designs reflect real‑world clinical practice and unmet need.
  • Ensure clinical protocols meet the highest standards of scientific integrity, operational feasibility, and regulatory alignment, supporting efficient execution and high‑quality evidence generation.
Clinical Study Execution amp; Oversight
  • Oversee the execution of all Cardiorenal clinical programs, directing cross‑functional interfaces to ensure robust, efficient, and high‑quality delivery of evidence across early‑ and late‑stage development.
  • Biostatistics amp; Data Management – Partner closely to ensure data integrity, statistical rigor, and high‑quality analyses that support regulatory submissions and scientific decision‑making.
  • Safety / Pharmacovigilance – Define safety strategy, oversee safety surveillance, interpret emerging safety signals, and ensure comprehensive risk‑benefit assessments throughout development.
  • Translational Medicine amp; Clinical Pharmacology – Guide biomarker strategy, PK/PD modeling, and mechanistic endpoint selection to strengthen scientific understanding and accelerate 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 amp; Scientific Communication
  • Lead regulatory strategy and submission development for the Cardiorenal 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 cross‑agency engagements.
  • Oversee 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, disease‑area lexicons, and evidence strategies across cardiorenal conditions.
  • Ensure alignment between clinical development strategy and field‑based 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 amp; Strategic Insight Integration
  • Guide the analysis, interpretation, and communication of clinical data across cardiology, nephrology, and heart failure expert audiences, ensuring scientific rigor and strategic clarity.
  • Synthesize emerging scientific, clinical, and competitive insights to refine development strategy, inform evidence‑generation plans, and adapt to evolving scientific trends.
  • Provide strategic recommendations to executive leadership based on trial learnings, external landscape shifts, and evolving therapeutic opportunities.
Cross‑Functional Leadership amp; Enterprise Influence
  • Partner with Commercial, Market Access, and Business Development to ensure clinical evidence supports market needs, access strategies, and differentiated product positioning.
  • Lead or support diligence activities for potential in‑licensing, collaborations, or partnerships across cardiorenal and 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.
  • Responsible for Cardiorenal TA medical/scientific resourcing and budget planning in partnership with SMLT Leaders.
People Leadership amp; Organizational Development
  • Serve on the Senior Medical Leadership Team and contribute to overall collective leadership for all medical issues across all Therapy Areas and Operational Functions, including but not limited to the Cardiorenal TA.
  • Mentor medical colleagues and cultivate an organizational culture grounded in scientific excellence, accountability, transparency, and cross‑functional collaboration.
  • Drive workforce planning, talent development, succession planning, and competency building to ensure the organization has the capabilities required for future growth.
Education and Experience Qualifications:
Education:
  • M.D. required, with clinical experience in medical practice preferred, ideally as a cardiologist, critical care physician, or nephrologist. An additional PhD, MPH, or MBA also highly valued.
Experience:
  • 10+ (15+) years of progressive medical affairs and/or clinical development experience within the pharmaceutical or biotechnology industry.
  • Demonstrated expertise in cardiovascular disease (and specific experience in congestive heart failure strongly preferred).
  • Track record of designing and executing clinical trials in cardiovascular chronic disease populations (and experience with wearable devices preferred)
  • Proven ability to lead and influence cross‑functional teams, collaborate effectively with investigators and scientific leaders, and represent programs in global regulatory 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, including biomarker strategy, pK/pD principles, translational medicine approaches, and regulatory pathways for cardiorenal diseases.
  • Knowledge of U.S. (and ex‑U.S.) regulatory and clinical research requirements relevant to cardiovascular drug development.
  • Demonstrated ability to integrate scientific insights, regulatory expectations, competitive intelligence, and operational considerations into cohesive, forward‑looking development strategies.

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