Director, Biologics and Biotherapeutics Development

Job Summary

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The National Institute of Neurological Disorders and Stroke (NINDS) is a leading supporter of biomedical research on disorders of the brain and the nervous system at the National Institutes of Health (NIH).

NINDS leads two major trans-NIH programs to support early translational efforts in therapeutics discovery and development - Blueprint Neurotherapeutics Network (BPN) and Pain Therapeutics Development program (PTDP) to advance the NIH mission and therapeutics discoveries towards clinical trials and ultimately patient use.

Located within the Division of Translation Research (DTR), the Director, Biologics and Biotherapeutics Development is intended to oversee the BPN Biologics Program and the Ultra-rare Gene-based Therapy (URGenT) Network to create significant synergy and efficiently accelerate therapeutics development designed to prevent and treat CNS disorders and is focused on the academic and small business community and is cost effective.

The Director exercises broad influence regarding highly complex neurotherapeutics development and policy issues and provides high-level leadership such as the following :

• managing a portfolio of neurotherapeutics development projects spanning from early discovery to late development;
• making sound judgements on stage appropriate risk for NIH investments in neurotherapeutics development projects as well as appropriate data driven discontinuation decisions in a timely manner;
• supervision of seven staff members involved in programs related to neurotherapeutics development;
• communicating with the extramural community, at national meetings, targeted foundations, webinars, and other forums;
• advising the NINDS Director and DTR Associate Director on research opportunities to advance the mission and success of the BPN-Biologics and URGent Network programs, and NINDS overall;

Required Qualifications

Applicants must possess a Ph.D. or equivalent doctoral degree, and have substantial multidisciplinary scientific expertise in biologics and neurotherapeutics development with experience advancing research ideas to the point of helping patients.

The Director must work with key opinion leaders and consultants across the therapeutics spectrum to solve and overcome translational challenges to help investigators move their products towards clinical trials in a timely and cost-effective manner.

Additionally, the Director must employ expertise in gene-based therapies, cell therapies, and experience developing novel, and emerging therapies is also required.

Significant executive level leadership is required to direct and influence teams to remain focused on critical path execution of milestone objectives in a timely fashion and within budgets.

The Director must understand the entire preclinical and early clinical product development pipeline including product optimization, preclinical scale-up, and manufacture and toxicology, regulatory affairs, and early human clinical trials.

The Director will lead multidisciplinary teams in investigational new drug application drug discovery and exercise understanding and experience in industry and academic settings to navigate and build relationships and partnerships with academics and small businesses in the Government setting.

Benefits

The position will be filled under a Senior Biomedical Research and Biomedical Product Assessment Services (SBRBPAS) excepted service appointment.

Salary is commensurate with the experience and a full package of Civil Service benefits is available, including retirement, health and life insurance, leave, and savings plan (401K equivalent).

Equal Employment Opportunity

The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.

Equal Employment Opportunity (EEO) for federal employees & job applicants.

Standards of Conduct / Financial Disclosure

If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450 to determine if a conflict or an appearance of a conflict exists between your financial interest and your prospective position with the agency.

Foreign Education

This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades).

Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer.

Learn more about Foreign Education.

Reasonable Accommodation

You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.

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