Associate Director, Global Clinical Science, Neuroscience

Associate Director, Global Clinical Science

Reports through the Clinical Development function which provides scientific expertise necessary to design and deliver clinical studies and programs.

• Responsible for implementation, planning, and execution of assigned clinical trial activities.
• Serves as Clinical Trial Lead for one or more trials.
• Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate supervision.
• Provides scientific and clinical leadership to a team of supporting Clinical Scientists (matrix leadership).
• Co‑leads study team meetings in partnership with GDO protocol manager and collaborates with cross‑functional study team members.
• May support clinical development planning by collaborating with Clinical Development Lead or Clinical Trial Physician for the provision and analysis of data to support future planning.

• Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members.
• Plan and lead the implementation of all study startup, conduct, and close‑out activities as applicable.
• Evaluate innovative trial designs in collaboration with Medical Monitor and Clinical Development Lead.
• Lead protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross‑functional comments and ensuring high clinical quality in collaboration with Medical Writing.
• Conduct site‑facing activities such as training and serving as primary contact for clinical questions.
• Oversee activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team.
• Identify clinical data trends; provide trends and elevate questions to Medical Monitor.
• Develop clinical narrative plan and review clinical narratives.
• Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
• Review development of site and CRA training materials and presentations at SIV and Investigator meetings; support on Study committee (e.g., DMC) activities.
• Draft/review and validate clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses).
• Collaborate and serve as primary liaison between external partners for scientific advice.

• Degree in Life Sciences (MD, PhD, PharmD, MS, RN, or other scientific field preferred).

• 5+ years of experience in clinical science, clinical research, or equivalent.
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, and clinical operations.
• Proficient knowledge and skills to support program‑specific data review, trend identification, and data interpretation.
• Knowledge of establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.

• Excellent verbal, written, communication, and interpersonal skills.
• Ability to communicate and collaborate across functions and job levels.
• Ability to assimilate technical information quickly.
• Initiative, detail‑orientation, and strong sense of teamwork.
• Proficient in Medical Terminology and medical writing skills.
• Proficient knowledge of disease area(s), KOLs, indications, compounds under study (including MOA, PK/PD, biomarker & safety profile).
• Proficient critical thinking, problem solving, and decision‑making skills.
• Understanding of functional and cross‑functional relationships.
• Commitment to quality.
• Adaptability and flexibility to adjust to multiple demands and shifting priorities.
• Proficient planning/project management skills.
• Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J‑Review or similar data reporting tools.

Domestic and international travel may be required.

Cambridge Crossing: $211,910 - $256,789… Madison - Giralda - NJ - US: $184,270 - $223,294… Princeton - NJ - US: $184,270 - $223,294

The starting compensation range(s) for this role are listed above for a full‑time…