Associate Clinical Scientist

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Summary

The Early Development Clinical Scientist Function provides scientific expertise necessary to design and deliver clinical studies and programs. This role supports the Immunology, Cardiovascular, and Neuroscience teams.

Position Summary / Objective

•    Responsible for implementation, planning, and execution of assigned clinical trial activities
•    Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision
•    Provides scientific and clinical leadership to clinical scientists on study team (matrix leadership)
•    May support clinical development planning in collaboration with Early Clinical Development physician(s)
Position Responsibilities
•    Maintain a thorough understanding of assigned protocols and protocol requirements and educate team members
•    Plan and lead the implementation of clinical study startup/conduct/close-out activities as applicable
•    Evaluate innovative trial designs in collaboration with the study physician
•    Manage protocol and ICF development process (e.g., documents and amendments) with minimal guidance; includes writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality in collaboration with Medical Writing. Present to governance committee and early clinical development team meetings as required.
•    Serve as primary contact for site-facing activities such as training and support for clinical questions
•    Conduct and oversee activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review
•    Identify clinical data trends; provide trends and escalate questions to study physician
•    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/develop site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., safety review) activities
•    Author/review clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses)
•    Collaborate and serve as primary liaison between external partners for scientific advice
•    Author/review abstracts, presentations, and manuscripts for external publications

Degree Requirements

•    Degree in Life Sciences (MD, PhD, Pharm D, MS, RN, BS or similar scientific field preferred)

Experience Requirements

•    For Associate Clinical Scientist, 0-2 years of experience in clinical science and clinical research
•    Proficient hands-on knowledge and experience in clinical development process
•    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
Preferred Experience:
Experience in Early Clinical Development designing and implementing all facets of early clinical studies

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
•    Detai