About the role
Provides scientific and clinical leadership to CMO. Serves as Clinical Scientist for one or more clinical trials. Successfully leads, plans, and executes clinical development activities for multiple trials. Partners with CMO and Project Management to lead the implementation of the Clinical Development Plans, as assigned. Collaborates with CMO, Clinical Operations, and Project Management for provision and analysis of data to support future planning.
Education / Background
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN, or another scientific field preferred)
- 8-10+ years of experience in R&D roles, clinical research, or equivalent
Responsibilities include, but are not limited to
- Maintain a thorough understanding of Clinical development Plans and assigned study protocol requirements; educate supporting team members, as required.
- Evaluate innovative trial designs in collaboration with CMO.
- Author key technical and clinical documents, including but not limited to, clinical study protocols, clinical study reports, and clinical portions of Regulatory Documents (e.g., IB, DSUR, Briefing Books, and regulatory responses)
- Initiate Protocol and ICF development process; including authoring, reviewing, adjudication/resolution of cross-functional comments, and ensuring high clinical quality in collaboration with Medical Writing.
- Coordinate efforts and collaborate with internal stakeholders (i.e., regulatory, translational, biostatistics, pharmacology/toxicology) to allow efficient execution of clinical studies.
- Responsible for the scientific aspects of the implementation and conduct of a clinical trial with both internal and external stakeholders (e.g., investigator meeting presentations, Advisory Boards, Governance, Regulatory Authority, data review and summary, protocol deviation review, etc.)
- Prepare and present information for external/ stakeholders’ meetings e.g., Advisory Boards, Governance, Regulatory Authority.
- Serve as primary contact for clinical questions and escalate to CMO, if appropriate.
- Oversee study data activities and trends related to data generation and validation, including CRF design, clinical data review to ensure an understanding of the interdependencies of the CRFs, agreed data conventions/rules and use of data review tools.
- Participate in and prepare presentations for scientific meetings such as DSMB, steering committees, scientific advisory boards, etc.
- Build relationships with external scientific and clinical thought leaders.
- Develop clinical narrative plans; review clinical narratives.
- Collaborate and serve as primary liaison between external partners for scientific advice.
- Author abstracts and prepare posters for external presentation/congresses
- Provide information required by Clinical Trial Manager for development of trial budget, CRO scope of work, etc.
Develop external and internal training materials. Present study protocols at SIV and Investigator Meetings.
Position Requirements & Experience Relevant Skills & Experience:
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Broad and solid understanding of functional areas of drug development, including but not limited to, preclinical, clinical operations, regulatory, pharmacovigilance, drug supply, and biometrics (including biostatistics and data management
- Proficient knowledge and skills to support program-specific data review, trend identification, data interpretation.
Acepodia is an equal opportunity employer offering a competitive salary and comprehensive package, including stock options, medical care, paid vacation, and holiday time. Title and salary commensurate with experience.