Clinical Scientist

BioCryst Pharmaceuticals

Posted on: April 17, 2021

Closing: May 17, 2021

Salary: Undisclosed

Position Type: Full Time

Job Description

BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO™ (berotralstat) is approved in the United States and Japan for the prevention of HAE attacks in adults and pediatric patients 12 years and older, and under regulatory review for approval in the European Union. BioCryst has several ongoing development programs including, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, and Korea. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.biocryst.com.

JOB SUMMARY:

The Clinical Scientist is responsible for ethical, medical and scientific rigor in development, conduct and reporting of assigned clinical studies across all stages of drug development and commercialization. Responsible for medical and scientific quality in the design, planning, initiation and successful completion of assigned clinical trials for new or marketed drugs for all phases of clinical development.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Develop clinical research documents, including clinical study synopses, protocols, CRFs, informed consent templates, clinical study reports, feasibility assessments, pediatric investigation plans and site selection strategies, in collaboration with the Clinical Operations team and study statisticians.
• Provides scientific input to clinical studies (as assigned) for a product candidate from early development to regulatory approval and beyond.
• Writes, edits and reviews medical and scientific elements of clinical research, operational, and regulatory documents to ensure accuracy, consistency with standard of care, logistical ease, and internal consistency.
• Ensures validity, accuracy, relevance and completeness of medical and scientific content in clinical research and regulatory documents.
• Responds to questions from regulatory and ethics committees at all stages of drug development as assigned.
• Establish and maintain quality corporate relationships with leading investigators and clinical sites on assigned protocols in collaboration with Clinical Operations team.
• Reviews clinical data and participates in data analysis to ensure quality and consistency across program, including identification of data trends to contribute to overall data quality.
• Supports operational teams with identification and deployment of appropriate measures to maintain speed of recruitment, site enthusiasm and motivation of site staff in collaboration with Clinical Operations team.
• Provide medical and scientific advice to the Clinical and Regulatory teams and educates investigators and site teams on the medical and scientific aspects of assigned studies.
• Contribute to the development of global regulatory strategies.
• Participate in development of publication strategies, writing and editing of draft presentations and manuscripts and interfaces with investigators.
• Attend appropriate scientific meetings to maintain awareness of research activities.
• Share scientific knowledge with the organization during continuing education sessions and CRA and vendor trainings, at an adapted level of understanding.
• All other duties as assigned.

 

EXPERIENCE & QUALIFICATIONS:

• PhD, PharmD or MD or equivalent with a minimum of 3 years of demonstrated industry experience in clinical research, including protocol design and execution required.
• Demonstrated track record of scholarship, independent research funding, publication and membership in scholarly societies OR proven track record of successful protocol development, execution and reporting in industry.
• Experience working in the rare or orphan disease space preferred.
• Experience in pediatric drug development, including PIP process preferred.
• Excellent interpersonal communication, collaboration, organization, and presentation skills.
• In-depth understanding of the clinical development process and its intricacies.
• Solid understanding of clinical trial design, biostatistics and data analysis.
• Familiarity with ICH and GCP.
• Strong project management skills.
• Ability to produce high quality work in a small company environment.
• Ability to understand, influence, collaborate and lead in a diverse team-based organization.
• Competence with standard office computer software tools.
• Ability to align activities with company objectives.
• “Roll-up-the-sleeves” attitude.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

BioCryst Pharmaceuticals

Posted on: April 17, 2021

Closing: May 17, 2021

Salary($): Undisclosed

Position Type: Full Time

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