Senior Director, Clinical Science

Job Title: Senior Director, Clinical Science

Department: Clinical

Location: Boston, MA / Hybrid

Employment Type: Full-Time

A biotech company operating in stealth mode in the neuropsychiatry space is seeking an experienced Clinical Trial Management professional to provide expertise in the development, execution and operations of clinical trials across all phases of development.

Position Summary

The Senior Director, Clinical Science provides scientific and operational leadership across the design, execution, monitoring, analysis, and interpretation of clinical development programs. This role partners closely with Preclinical Development, Clinical Operations, Biostatistics, Pharmacology, Regulatory, Safety, Medical Writing, and external experts to ensure studies are scientifically rigorous, operationally feasible, and aligned with program and regulatory strategy. The Director is expected to function as a senior clinical science leader, drive cross-functional decision-making, and contribute meaningfully to program-level strategy across early and late phase development.

Key Responsibilities

· Provide strategic clinical science leadership for assigned development programs, including study concept development, protocol design, endpoint selection, data review, interpretation, and clinical study execution support.

· Partner with the Medical Lead to translate program strategy into high-quality clinical development plans and study designs across Phase 1 through Phase 3 and lifecycle activities, as applicable.

· Lead authoring and review of clinical study protocols, protocol amendments, study synopses, clinical sections of Investigator’s Brochures, and other core clinical development documents in collaboration with Medical Writing and cross-functional contributors.

· Drive the clinical science contributions to regulatory submissions and responses to health authority questions, including briefing packages, IND/CTA-related documents, and study-specific materials.

· Lead ongoing reviews of study conduct and emerging clinical data to ensure scientific integrity, subject safety, data quality, and timely identification and resolution of risks or issues.

· Serve as a senior clinical science representative in cross-functional teams and governance forums, helping to align Clinical Development, Operations, Data Management, Biostatistics, Safety, Regulatory, and Translational colleagues around study objectives and decisions.

· Contribute to statistical analysis strategy and data review planning in partnership with the medical lead and biostatistics, including review of SAPs, data outputs, tables, listings, and figures.

· Interpret clinical study results and support development of key deliverables such as clinical study reports, abstracts, presentations, manuscripts, and internal decision documents.

· Provide scientific leadership for investigator interactions, advisory boards, investigator meetings, and site engagement on protocol and study-related scientific questions.

· Maintain deep knowledge of the relevant therapeutic area, competitive landscape, emerging science, and evolving standards of care to inform development strategies and study design.

· Mentor junior Clinical Scientists and contribute to the development of department standards, processes, and best practices.

· Identify program risks proactively and drive cross-functional problem-solving in a matrix environment with a high degree of accountability and influence.

Required Qualifications

· Advanced degree in a scientific or clinical discipline required; PhD, PharmD, MD, or equivalent strongly preferred.

· Typically 8 to 12 years of experience in clinical research and drug development in the biotechnology or pharmaceutical industry, including substantial experience in a Clinical Scientist or related drug development role.

· Demonstrated experience supporting or leading clinical programs across early and late stage development in the neuropsychiatry space

· Strong working knowledge of GCP, ICH guidelines, and applicable regional and local regulatory requirements.

· Experience contributing to or leading protocol development, data review, regulatory interactions, and cross-functional study execution.

· Ability to critically evaluate clinical and scientific data and integrate findings into clear development recommendations.

· Solid understanding of biostatistics and clinical trial methodology sufficient to lead data discussions and partner effectively with statistical colleagues.

· Excellent written and verbal communication skills, including the ability to present complex scientific and clinical information to internal leadership, investigators, and external advisors.

· Demonstrated success working effectively in matrixed, multidisciplinary, and globally distributed teams.

· Strong organizational skills, sound judgment, and the ability to manage multiple priorities in a fast-paced development environment.

Preferred Qualifications

· Direct experience in the company’s therapeutic area or closely related indications.

· Prior experience with health authority submissions, inspection-readiness activities, and responses to regulatory queries.

· Experience representing Clinical Science in governance settings and influencing program-level decisions.

· People leadership, mentoring, or line management experience is preferred.

Core Competencies

· Strategic thinking and scientific judgment

· Clinical trial design and data interpretation

· Cross-functional leadership and influence

· Regulatory awareness

· Clear scientific communication

· Proactive risk identification and problem-solving

Please submit resume to recruiterbiotech@gmail.com