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Senior Clinical Scientist, Late Clinical Global Drug Development

Company: Bristol-Myers Squibb
Location: Toms River
Posted on: January 16, 2022

Job Description:

Senior Clinical Scientist Functional Area Description The Senior Clinical Scientist reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs. Position Summary / Objective 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) Position Responsibilities 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 Evaluate 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 Requirements Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred) Experience Requirements 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 Key Competency Requirements Excellent verbal, written, communication and interpersonal skills Must be able to effectively communicate and collaborate across functions and job levels Ability to assimilate technical information quickly Routinely takes initiative Detail-oriented Strong sense of teamwork; ability to lead team activities 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 Commitment to Quality Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability 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 Travel Required Domestic and International travel may be required. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture. To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Keywords: Bristol-Myers Squibb, Brick , Senior Clinical Scientist, Late Clinical Global Drug Development, Healthcare , Toms River, New Jersey

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