Global Head of Clinical Development (Sr. Director-VP)
Global Head of Clinical Development (Sr. Director-VP)
Hybrid NJ or Fully Remote (East Coast Preferred)
Compensation: $300,000-350,000 + bonus
Company Summary:
This is a U.S.-based pharmaceutical organization backed by a large, well-established global parent company, now making a deliberate shift toward innovative, branded drug development. While historically commercially focused, the business is investing heavily in building a differentiated R&D engine with the U.S. as its central market. The pipeline is intentionally focused, with a small number of early- to mid-stage (Phase I/II) programs, led by a priority women's health biologic alongside emerging immunology and cardiometabolic assets. The company has the infrastructure and resources of a larger organization but is operating with a more agile, build-oriented mindset.
Responsibilities:
- Define and execute global clinical development strategy across biologic and small molecule programs, aligning scientific, regulatory, and commercial objectives with a strong emphasis on the U.S. market.
- Build and scale a high-performing, matrixed clinical development organization (including Clinical Operations), advancing programs from Phase I through Phase III.
- Integrate translational science, biomarkers, and patient-centric endpoints into clinical strategy to strengthen differentiation and probability of success.
- Partner with external stakeholders and KOLs to design efficient, high-impact development programs across women's health, global health, and cardiometabolic indications.
- Establish and expand strategic external partnerships to enable collaborative development and access non-dilutive funding opportunities.
- Lead global regulatory engagement (FDA, EMA, CDSCO and others) to define optimal clinical pathways and ensure compliant, cost-effective program execution.
- Oversee global clinical execution through CRO partnerships, ensuring scientific rigor, data integrity, and on-time delivery of key milestones.
- Collaborate cross-functionally with Commercial, Medical Affairs, and Market Access to ensure clinical data supports value demonstration and successful global launches.
- Contribute to business development activities, providing clinical leadership in due diligence, in-licensing, and co-development opportunities.
- Build and lead global KOL advisory boards to continuously refine strategy based on evolving science and unmet patient needs.
Qualifications:
- M.D. or PhD
- At least 10 years of clinical development experience within the pharmaceutical or biotechnology industry.
- Broad therapeutic experience.
- Ideal candidates will have experience in one or more of the following areas: Women's health, Immunology, Cardiometabolic, or Cell Therapy.
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