National Center for Advancing Translational Sciences - Rockville, Maryland with full federal government benefit package including retirement, health, and life insurance.

The National Center for Advancing Translational Sciences (NCATS), a major research component of the National Institutes of Health (NIH) and the Department of Health and Human Services (DHHS), seeks to identify an outstanding Director for its Therapeutic Development Branch within the NCATS Division of Preclinical Innovation, located in Rockville, Maryland. The Division of Preclinical Innovation (DPI) encompasses all of aspects translational science from target validation to first-in- human clinical studies. DPI has both technology development components and collaborative resource access programs, covering small molecule and RNAi screening technologies and informatics, and catalyzes translational efforts in biology, medicinal chemistry, pharmacokinetics, toxicology, absorption, distribution, metabolism, excretion (ADME), and project management. The Therapeutic Development Branch (TDB) includes the Therapeutics for Rare and Neglected Diseases (TRND) and Bridging Interventional Development Gaps (BrIDGs) programs.

This position serves as a Senior Scientist directing the Therapeutic Development Branch (TBD) that is located within the Division of Preclinical Innovation (DPI). This position is responsible for planning and directing a broad and comprehensive program in preclinical and late-stage drug development, including lead optimization, drug metabolism, toxicology, pharmacology, formulation development, process chemistry, natural history studies, investigational new drug (IND) and biologics license application (BLA) enabling work, cell and gene therapy development, and biomarker development. Further, this position serves as the spokesperson for the Branch at conferences and various stakeholder meetings, including the US Food and Drug Administration (FDA), and international regulatory agencies, and will also catalyze collaborations between his/her Branch and the other branches and programs within DPI and NCATS. In consultation with the NCATS Scientific Director (SD), the incumbent is responsible for establishing the goals and objectives for the Therapeutic Development Branch, ensuring consistency with goals and objectives established at higher levels within the Center. In addition, develops long-range and short-range plans and establishes priorities; determines the resources required to support planned activities; develops, presents, and defends annual budgets for the programs; develop spending plans based on approved budgets; and adjusts plans and budgets in response to changes in program emphasis or new developments. In consultation with the NCATS Scientific Director, the incumbent is also responsible for establishing the goals and objectives for the TDB, ensuring alignment with the goals and objectives determined at higher levels within the Center, and managing a collaborative portfolio of preclinical projects. The candidate is responsible for developing long and short-range plans and establishing priorities, determining the resources required to support planned activities, and developing and defending annual budgets for the program. Finally, this position supervises the staff assigned to some of DPI's programs.

Qualifications: Applicants must have completed the requirements for a bachelor's (or graduate) degree in a biological science, agriculture, natural resource management, chemistry, or related disciplines appropriate to this position, from an accredited college or university or have a combination of experience and education which includes courses comparable to a major in a

biological science, agriculture, natural resource management, chemistry, or related disciplines appropriate to this position and have appropriate experience or additional education which demonstrates similarly appropriate skills or abilities needed to perform the duties of this position. Applicants must have demonstrated experience in leading a cohort of scientists from diverse scientific backgrounds (e.g., synthetic chemists, biochemists, cell biologists, toxicologists, bioinformaticians and pharmacologists) to conduct a preclinical development program focused on rare genetic disorders and neglected tropical diseases all the way through Investigational New Drug (IND) filing and first-in-human testing; research experience in multi-disciplinary environments working on highly complex problems related to preclinical development of various therapeutic modalities, including, but not limited to, small molecules, antisense oligonucleotides, biologics, and cell and gene therapies; applying a broad range of drug discovery approaches in all aspects of late-stage drug development to solve technical problems that lead to commercialization of therapeutics; research experience in preclinical translation from target validation through the early development of therapeutics and/or diagnostics to proof-of-concept in humans.

The ideal candidate will have knowledge of the evolving fields of molecular biology, biochemistry, pharmacology, toxicology, and medicinal chemistry, and experience with GMP scale-up, large molecules, cell and gene therapy approaches, and regulatory affairs.  You must have demonstrated experience in directing and managing a large and scientifically diverse research program that involves collaborating with scientists across government, academia, industry and patient advocacy groups to accomplish scientific objectives.  You should be both nationally and internationally recognized and a highly accomplished researcher in all aspects of preclinical translation, with a particular interest and accomplishment in novel technology and paradigm development. You should demonstrate expertise and accomplishment in multiple aspects of preclinical translation from target validation through the early development of therapeutics and/or diagnostics to proof-of-concept in humans, and broad and first-hand knowledge of the field of rare disease therapeutic development, including small molecule, biologic, and gene-therapy approaches. Experience developing and teaching educational materials in preclinical translation is desirable, but not required. Additionally, a strong background in biomedical sciences, as well as a record of accomplishment in academic and or biopharmaceutical preclinical translation with demonstrated experience leading multi-disciplinary research groups in technology and therapeutic/diagnostic/intervention development.

Salary and Benefits: The salary range is commensurate with experience and accomplishments. A full federal government benefit package (including retirement, health, life and long-term care insurance, Thrift Savings Plan participation, etc.) is available. The National Institutes of Health inspires public confidence in our science by maintaining high ethical principles. NIH employees are subject to Federal government-wide regulations and statutes as well as agency-specific regulations described at the NIH Ethics website: http://ethics.od.nih.gov.

How to Apply: Please submit a cover letter describing your interest in the position including a career synopsis (1-3 pages); a statement of research interests in collaborative research (1-2 pages); a statement of experience and commitment to enhancing diversity, equity, and inclusion, and accessibility at the workplace (1 page), a current curriculum vitae and complete bibliography; and the names and contact information of five references to NCATSRecruitAC1579@mail.nih.gov. Please include in your CV a description of mentoring and outreach activities in which you have been involved, demonstrating commitment to workforce diversity enhancement.  Application packages will only be accepted electronically through the email listed above and must be received between the dates of 8/23/2024 – 9/22/2024.

All information provided by candidates will remain confidential and will not be released outside the NCATS search process without a signed release from candidates. The NIH encourages the application and nomination of qualified women, minorities, and individuals with disabilities. DHHS and NIH are Equal Opportunity Employer.

About National Center for Advancing Translational Sciences

The National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health, is improving health through smarter science. NCATS conducts and supports research on the science and operation of translation to allow more treatments to get to more patients more quickly. The Center focuses on what is common across diseases and the translational process by studying translation on a system-wide level as a scientific and operational problem. Working in partnership with the public and private sectors, NCATS strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline; demonstrate their usefulness; and disseminate the resulting data to the broader scientific community.

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