Associate Director, Global Clinical Science, Neuroscience

- 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 level of supervision

- Provides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership)

- Co-Leads study team meetings in partnership with GDO protocol manager; and collaborate with cross functional study team members

- May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for 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 all study startup/conduct/close-out activities as applicable

- Evaluat e innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)

- Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)

- Site-facing activities such as training and serving as primary contact for clinical questions

- Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team

- Clinical data trend identification; provide trends and escalate questions to Medical Monitor

- Develop clinical narrative plan; review clinical narratives

- Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.

- Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities

- Drafting/review and validation of 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, Pharm D, 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, clinical operations

- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation

- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees

- Excellent verbal, written, communication and interpersonal skills

- Must be able to effectively communicate and collaborate across functions and job levels

- Proficient in Medical Terminology and medical writing skills

- Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)

- Proficient critical thinking, problem solving, decision making skills

- Understanding of functional and cross-functional relationships

- Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an a bility to meet day-to-day challenges with confidence and professionalism

- Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)

- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools

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

Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.

For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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