Senior Director/Director Clinical Development

Role Summary

Senior Director/Director of Clinical Development. Location: New Jersey, US; Cambridge, US; Gaithersburg, US. Full-time. Oversees design and execution of clinical trials across all phases, ensuring data integrity, patient safety, and regulatory approval. Leads matrix teams with expertise in Immuno-Oncology and Oncology to drive program strategy and medical decision-making.

Responsibilities

• Lead clinical trial design to develop plans for new compounds from early exploratory studies through late-stage development and regulatory approval.
• Collaborate with the VP to operationalize clinical strategies for assigned portfolios and ensure alignment across functions.
• Serve as Program Lead, guiding core teams, driving program strategy, and preparing submission processes.
• Ensure patient safety by overseeing medical aspects of studies, conducting risk-benefit assessments, and addressing medical queries.
• Innovate in trial design, leveraging digital endpoints and real-world evidence to enhance study outcomes.
• Develop key clinical documents, including Investigator’s Brochures, NDAs, and high-quality Clinical Study Reports.
• Build strong relationships with external stakeholders while representing the team in governance meetings.

Qualifications

• M.D. degree with a robust scientific and clinical background in Immuno-Oncology or Oncology.
• Extensive experience leading clinical development programs across Phases I–III, including NDA submissions.
• Expertise in advanced clinical study designs, companion diagnostics for patient selection, translational modeling, biostatistics, and confirmatory Phase III trial design.
• Proven experience interacting globally with health authorities (e.g., EMA, FDA), with successful registration being advantageous.
• Strong medical acumen in monitoring safety/efficacy data and managing patient-centric drug development processes.
• Exceptional leadership skills to mentor teams while accelerating capabilities through situational management styles.