Job DescriptionProvide scientific expertise for developing clinical evaluations, risk management, and /or clinical studies. Writes/manages clinical evaluation reports or clinical trial protocols clinical trial registrations and results postings and scientific publications. This position will drive scientific activities associated with the design, conduct and reporting of clinical trials for assigned therapeutic areas, interfacing with the Medical Affairs, Regulatory, Clinical Research, R&D, and Marketing departments. Typical duties might include:
- Provide scientific support to justify trial design and ongoing scientific analysis during protocol development, including generation of pre-protocol documentation of scientific information.
- Lead the generation of study-related documents and/or contribute content and oversight of such documents including clinical study protocols, reports of priors, investigational brochures, and case report forms.
- Synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area.
- Responsible for updating medical affairs procedural documents and submitting change requests when needed.
- Generate documents to support regulatory submissions and/or respond to questions from regulatory authorities about existing submissions.
- Review and critically analyze clinical data and statistical analysis plans.
- Participation in scientific report writing. Presentation of methods, results and conclusions to a publishable standard. Lead study level publication planning.
- Support the generation of white and position papers by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice.
- Lead publications for clinical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts.
- Contribute to the optimization of internal processes and workflows.
- Assist the medical director with direct customer interactions as needed.
Qualifications- Must have a master's degree in a relevant science, medicine, or similar discipline.
- Must have at least five (5) years of relevant clinical research scientist experience.
- Strong leadership skills since position requires significant interaction with executive leadership, physicians and regulatory authorities.
- Knowledge of Good Clinical Practices (GCP) is required.
- Excellent writing and editing skills, and a keen attention to detail.
- Strong verbal, written, and interpersonal communication skills.
- Clinical protocol development experience.
- Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases.
- Proven analytical skills working with clinical or research data.
Desired Qualifications- PhD with a minimum of three (3) years' experience in clinical research.
- Experience as author or contributor or peer-reviewed manuscripts is strongly desired.
- Knowledge of patient safety, quality, clinical research, strategic planning, health biostatistics or epidemiology is desired.
- Experience interacting with FDA or China regulatory agencies highly preferred.
Salary Range$147,532 - $193,635 (Financial compensation packages may be higher/lower than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand).
