Director, Toxicology, Non-Clinical Development
Remote, CA, USA | BioCryst Pharmaceuticals, Inc.
Industry:Pharmaceutical / Biotech
Job Description:59 people have viewed this job
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.
Accountable for leading the toxicology strategy for successful development of the company’s small molecule and biologics across all stages of development. Responsibilities include the design, planning, initiation and successful completion of toxicology studies required for new or marketed drugs for all phases of development. #LI-Remote
ESSENTIAL DUTIES & RESPONSIBILITIES:
• Responsibility extends from first concept to regulatory filing of completed studies.
• Accountable for non-clinical toxicology and safety pharmacology activities.
• Manage all aspects of out-sourced activities, including proposal generation and approval, vendor selection, protocol generation, study conduct and monitoring, report review and approval.
• Accountable for selection and management of qualified vendors for non-clinical studies.
• Accountable for oversight and corporate approval of GLP non-clinical research documents including for example non-clinical study synopses, protocols, analysis plans, and study reports.
• May represent the company as non-clinical safety representative at meetings with regulatory bodies.
• Responsible for validity, accuracy, relevance and completeness of scientific content in non-GLP and GLP non-clinical research and regulatory documents.
• Responsible for original writing, editing and review of non-clinical GLP regulatory documents.
• Play a pivotal role in IND candidate selection and all stage gate processes.
• Attend appropriate scientific meetings and stays up to date with relevant scientific literature to maintain expertise.
• Accountable for incorporating relevant recent advances in the field into non-clinical research.
Responsible for oversight of the conduct of non-clinical studies
• Responsible for proposing and managing budgets.
• Accountable for corporate strategic relationship development with non-clinical study vendors.
Responsible for providing non-clinical expertise to Product Teams throughout the product lifecycle
• Accountable for non-clinical strategic and tactical advice to product teams.
• Contributes to the development of global regulatory approval strategies.
• Participates or leads in development of non-clinical publication strategies, writing and editing of draft presentations and manuscripts, and interactions with external non-clinical investigators.
• Responsible for sharing scientific knowledge with the organization during continuing education sessions, at an adapted level of understanding.
• Attends appropriate scientific meetings to maintain awareness of research activities.
EXPERIENCE & QUALIFICATIONS:
• PhD degree in toxicology or pharmacology with relevant postdoctoral experience.
• DABT preferred but not essential.
• Demonstrated drug development experience within the pharmaceutical or biotechnology industry in non-clinical toxicology, including program design, study protocol development and study execution, minimum 10 years preferred.
• Experienced with non-clinical development programs for biologics (monoclonal antibodies, fusion proteins) and small molecules.
• Experienced in development programs for oral and parenteral therapeutics.
• Proven experience with virtual drug development as it pertains to non-clinical drug development.
• In depth understanding of the drug development process and intimate understanding of non-clinical development.
• In depth familiarity with ICH, FDA and other regulatory guidance and regulations relevant to non-clinical research.
• Excellent written and oral communication, interpersonal, and organizational skills.
• Initiative in producing high quality work product in a small company environment.
• Roll-up-the-sleeves attitude.
• 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.
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.
BioCryst requires all U.S. based employees to either (a) establish that they have been fully vaccinated against COVID-19; or (b) obtain an approved exemption as an accommodation. Proof of vaccination or an approved exemption form is required after a conditional job offer has been made to the applicant and prior to the start date. This requirement is a condition of employment at BioCryst, and it applies regardless of whether the position is located at a physical BioCryst location or is fully remote.
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)
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