Associate Director/Director Clinical Science
The Associate Director/Director Clinical Scientist provides scientific expertise throughout the development and implementation of clinical evaluations, risk management and /or clinical studies. Writes/manages clinical evaluation plans and reports, clinical trial protocols, protocol amendments, risk master lists, clinical study project timelines, clinical trial registrations and results postings, and scientific publications. Interacts with various study support groups and cross-functional teams in order to assist in clinical strategy, the development of plans and reports, and project deliverables. Interacts with regulatory agencies as needed, and will use their scientific and medical knowledge in order to provide directives to staff as well as study sites.
This cross-functional role includes assembling, evaluating, and presenting scientific and medical data, assisting with writing manuscripts (paper, abstracts, posters, etc.), and reviewing and summarizing relevant literature. Responsibilities will also include data review and trial management activities.
Major Duties and Responsibilities
Responsibilities will include, but not be limited to:
- Writes clinical evaluation plans and reports, study protocols, protocol amendments, informed consents, study reports, risk master lists, and scientific papers for publication.
- Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction.
- Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
- Reads and interprets scientific and medical literature for the use in clinical documents and to assist clinical team decision making
- Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice.
- Creates, manages, or participates in clinical study timelines and budgets by utilizing the appropriate project management tools, selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines
- Presents scientific data by communicating accurate, succinct summaries of clinical results at industry gatherings, investigational meetings and regulatory agency meetings.
- Reviews clinical study data; identify and evaluate study data trends, outliers, and protocol deviations
- Collaborates on review of safety narratives and other safety-related guidelines and documentation.
- Participates and develops communication strategies for existing and concluded studies through KOL interactions, advisory boards, scientific and industry conferences and meetings, and publications
- Presents internally for clinical trial/program training; externally (when required) to investigators/clinical trial site personnel (e.g., site initiation visits, investigator meetings), data safety monitoring boards (DSMBs), at regulatory agency meetings, conferences and/or advisory boards.
- Minimum of 5 years of related work experience with a substantial understanding in PCI, or an equivalent combination of education and work experience.
- Is recognized as a resource in work group and across functions. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
- Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Outstanding written and oral communication skills
- Strong scientific background, with clinical and/or research experience in coronary artery disease (e.g. PCI)
- Familiarity with clinical operations and conduct of clinical research, with a thorough understanding of ICH, GCP, and relevant regulatory requirements
- Strong analytical and strategic thinking skills
- Experience interacting with clinical investigators, medical experts and Key Opinion Leaders
- Experience and knowledge in clinical statistics, data management, CRF development, monitoring
- Excellent verbal, written, and interpersonal communication skills (fluency in written and spoken English is required)
- Thorough working knowledge of personal computer systems and desktop office applications, including proficiency in MS Word, Excel, PowerPoint and Microsoft Project
- Bachelor’s degree in the sciences, medicine, statistics, or related discipline required
- Advanced degree highly preferred (MS, PhD, MD)