Senior Clinical Research and Development Manager
5 days ago
We are seeking a highly experienced and skilled Senior Director, Clinical Research Scientist to join our team at Advanced Clinical. This is a key leadership role that will be responsible for collaborating with physicians in Clinical Development to deliver clinical research support for assigned programs.
Key Responsibilities- Protocol Development
Develop and implement clinical study protocols to ensure timely and effective delivery of clinical research support.
Program StrategyContribute to the development of program strategy for assigned compounds/programs, including participating in the preparation of clinical development plans.
Clinical Scientific DocumentsDraft and review clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports, and other Health Authority submissions.
eCRF Design and ReviewProvide clinical input into eCRF design, SAP, and TLFs to ensure accuracy and completeness of clinical data.
Study Data ReviewCollaborate with study team members to conduct timely and thorough review of study data using best practices and available tools to identify and evaluate data trends.
Project Team RepresentationRepresent clinical development on project teams to ensure effective communication and collaboration.
External ExpertiseDevelop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design.
Abstracts, Posters, and ManuscriptsAct as the clinical lead for study abstracts, posters, oral presentations, and manuscripts for assigned studies.
Liaison and CommunicationServe as a liaison to project teams, CROs, Clinical sub-teams, and others to ensure effective communication and collaboration.
Competitive LandscapeMaintain updated knowledge of the competitive landscape in regard to assets with similar mechanisms of action (MOA) and/or evolving standards of care for indications of interest.
Qualifications- Education
Degree in a scientific/life-sciences field. Pharm.D. or Ph.D. preferred.
ExperienceA minimum of 8 years of experience in research, with at least 5 years of drug development experience required. Alternative drug development experience will be considered.
Preferred ExperiencePrior experience in IAI and/or Dermatology Drug Development is preferred.
SkillsAbility to work independently, multitask, and work in a fast-paced environment. Excellent written and oral communication skills. Strong analytical ability. Ability to accommodate up to 20% travel or as business dictates.
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