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Clinical Scientist (Endocrinology)

Menlo Park, CA, United States

The Clinical Scientist (Endocrinology) will ensure the clinical and scientific integrity of clinical trials conducted by Company in the therapeutic area.

Responsibilities:

Act as clinical scientist and clinical subject matter expert for both Company team members and for external contacts related to the assigned therapeutic programs

Provide training and ongoing input to all members of the clinical team on medical and scientific issues related to the therapeutic field in question

Provide scientific oversight for Company operational staff, contract research organizations (CROs), and clinical trial sites in all areas related to the therapeutic programs

Collaborate in the writing and review of protocols, investigator brochures, study reports and other clinical and regulatory documents

Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports

Acts to provide clinical oversight and contributes to safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee

Play a key role in the analysis, interpretation and delivery of high-quality clinical data

Interact with principal investigators and opinion leaders to facilitate clinical trials research

Participate in appropriate regulatory discussion and activities, including the filing of IND’s, CTXs, NDA/MAAs, throughout the development cycle

Participate in clinical study report conceptualization, development and writing for global regulatory submissions

Work closely and collaboratively with other functions, e.g. clinical operations, safety, biometrics, regulatory, medical writing, medical affairs and commercial

Develop and give internal and external presentations as subject matter expert for the therapeutic area

Participate in the development and review of publications

Prepare and monitor budgets in collaboration with clinical operations and R&D finance

Serve as liaison to the commercial team on scientific issues

Preferred Skills, Qualifications and Technical Proficiencies:

Strong clinical and scientific knowledge

Excellent communicator with proven leadership skills and the ability to interact in a cross functional environment

Comfortable in a fast-paced and nimble small company environment and able to adjust workload based upon changing priorities

Preferred Education and Experience:

Pharm D, PhD, MD or equivalent, preferably with experience in endocrinology therapeutic area(s)

Relevant at least 5 years of relevant clinical development experience is viewed favorably.

Relevant basic and/or clinical research experience in academic settings is viewed favorably

The pay range that the Company reasonably expects to pay for this headquarters-based position is $215,300 - $253,300 ; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.

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