Clinical Development Therapeutic Area Head Cardiorenal (ED/VP)
Clinical Development Therapeutic Area Head Cardiorenal (ED/VP)
Greater Boston Area - Hybrid
Compensation: $300,000-396,000 + bonus + RSU's
Company Summary:
We're partnering with a mid-sized biotech leading the way in endocrine, orphan lung, and cardiorenal therapeutics. With multiple FDA-approved products, the company is scaling rapidly and building on a strong foundation of commercial success. What makes this opportunity compelling is the combination of proven impact and continued growth. The organization has demonstrated the ability to meaningfully improve patients' lives today, challenging the idea that you need to be working on something entirely novel to have real clinical impact. Here, the focus is on delivering therapies that are effective, accessible, and truly change the day-to-day experience for patients. At the same time, the pipeline continues to expand across internal programs and strategic partnerships, providing exposure across early development, lifecycle management, and portfolio-level decision-making. This creates an environment where a clinical leader can operate beyond execution, shaping strategy, influencing program direction, and contributing to the long-term build of the organization. If you're motivated by driving clinically meaningful programs, working with validated science, and stepping into a role with both strategic visibility and real impact, we'd welcome the opportunity to connect and share more.
Primary Responsibilities:
- Advance clinical programs across diabetes and related chronic disease areas, contributing to therapeutic area strategy and integrating clinical, scientific, and competitive insights into pipeline prioritization and lifecycle planning
- Partner with the TA Head to shape and execute lifecycle strategy for the diabetes portfolio, ensuring alignment with broader scientific platforms and enterprise objectives
- Lead design of Phase 1-4 clinical trials, including dose selection, patient segmentation, biomarker strategy, and endpoint development
- Engage internal experts and external KOLs across endocrinology (and pediatrics) to refine study rationale and optimize development pathways
- Oversee advisory board strategy to ensure clinical programs reflect real-world practice and unmet need
- Ensure protocols are scientifically rigorous, operationally executable, and aligned with regulatory expectations
- Support execution of clinical programs across all phases, ensuring effective cross-functional coordination with Clinical Ops, Biostats, Data Management, and related teams
- Partner with Biostatistics and Data Management to ensure data integrity, statistical rigor, and high-quality analyses
- Contribute to safety strategy, including pharmacovigilance oversight, signal detection, and risk-benefit assessment
- Provide input on CRO/vendor oversight, operational planning, and study execution
- Maintain accountability for medical monitoring across studies
- Ensure compliance with global regulatory requirements (FDA, EMA, GCP) and inspection readiness
- Drive regulatory strategy and support key submissions (INDs, NDAs/BLAs, CSRs, briefing documents), representing the therapeutic area in health authority interactions
- Contribute to development and review of clinical and regulatory documents and broader scientific communications
- Partner with Medical Affairs to align clinical development with scientific messaging and evidence generation, supporting publication planning and external engagement
- Guide interpretation and communication of clinical data across diabetes and pediatric audiences, integrating emerging insights to refine development strategy
- Provide strategic input to leadership based on clinical data, evolving science, and competitive landscape
- Partner cross-functionally with Commercial, Market Access, and Business Development to ensure evidence supports differentiation and access strategy
- Support diligence and partnership activities across diabetes and related disease areas
- Contribute to governance, portfolio decisions, and pipeline prioritization
- Mentor medical colleagues and support development of a collaborative, high-performing scientific organization
Ideal Qualifications:
- 5+ years clinical development and/or medical affairs experience in industry.
- M.D. required, with clinical training and practice experience preferred, ideally within cardiology, critical care, or nephrology.
FAQs
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