The National Center for Advancing Translational Sciences (NCATS), is seeking a a Senior Scientist with scientific, administrative, and leadership credentials who can lead a program in The Therapeutic Development Branch (TDB) within the NCATS Division of Preclinical Innovation (DPI). The program develops new systems, novel approaches, and methodologies to achieve conceptual breakthroughs in developing preclinical therapeutics.

Duties

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.

Requirements

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
• Applicants must meet all qualification requirements by the closing date of this announcement.
• Males born after December 31, 1959 must be registered with the Selective Service.
• Position requires Education.

Qualifications

In order to qualify for a Supervisory Biochemist, GS-0401-15 position you must meet the following requirements: BASIC QUALIFICATIONS: A. 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 B. 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. ADDITIONAL QUALIFICATIONS: In addition to meeting the education requirements, you must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-14 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: directing and managing a large and scientifically diverse research program; leading a laboratory in conducting 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 with 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; research experience in preclinical translation from target validation through the early development of therapeutics and/or diagnostics to proof-of-concept in humans. IDEAL CANDIDATE: 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. You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay. Do not copy and paste the duties, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12335102

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. Click here for information on Foreign Education.

Contacts

• Address National Institutes of Health 6701 Rockledge Drive Bethesda, MD 20892 US
• Name: Ryan Gale
• Email: [email protected]