Senior Director/Director Clinical Development

Role Summary

The (Senior) Director, Clinical Development will collaborate closely with the VP of Clinical Development to lead clinical strategies for assigned programs. This role involves overseeing the design and execution of clinical trials from early to late stages, ensuring data integrity, patient safety, and regulatory approval. You will lead a matrix team and apply your deep understanding of scientific, medical, and disease biology to guide decisions.

Responsibilities

• Oversee and steer clinical trial design and execution, developing clinical plans for new compounds and leading towards regulatory approval.
• Collaborate with the VP to operationalize clinical strategies for assigned portfolios.
• Lead program strategy, development plans, and submission processes.
• Serve as Program Lead, guiding core teams and aligning objectives across functions.
• Ensure medical and safety aspects of studies, including risk-benefit assessments and medical queries.
• Work closely with Clinical Operations to ensure patient-centric drug development.
• Drive innovation in trial design, leveraging digital endpoints and real-world evidence.
• Prepare key clinical documents (e.g., Investigator‚Äôs Brochures, NDAs) and ensure high-quality medical content in Clinical Study Reports.
• Manage relationships with external stakeholders and represent the team in governance meetings.

Qualifications

• M.D. with strong scientific and clinical background in Immuno-Oncology, Oncology
• Several years of experience within Immuno-Oncology, Oncology at the biotech/pharmaceutical and the academic setting, including leading clinical development programs from exploratory Phase I/II clinical studies through late stage development in Phase III and NDA submission.
• Thorough understanding of the clinical and scientific methods and approaches used in clinical development studies, as
• novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/ translational modeling and biostatistics. Complemented with several years of experience on confirmatory PH3 trial design and respective dossier preparation and submission activities.
• Experienced in global health authority interactions (EMA, FDA, MHRA, CDE). Having participated or led a drug development program to successful registration is an advantage.
• Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects.
• Ability to apply situational management style to both mentor and accelerate capabilities of its reports

Skills

• Clinical development leadership
• Trial design and regulatory submission processes
• Medical and safety oversight of studies
• Stakeholder management and governance
• Experience with immuno-oncology/oncology programs
• Global health authority interactions

Education

• M.D. (required)

Additional Requirements

• Location: New Jersey, US; Cambridge, US; Gaithersburg, US (as applicable)