Job Description

Rejuvenate Bio is seeking a motivated, flexible, and strategic individual to join our team and lead the translation of our preclinical research into clinical development! The Head of Translational Science will provide scientific strategy and operational leadership in preclinical development and translational science for our AAV-mediated gene therapy programs in cardiac, metabolic, and renal therapeutic areas, among others. This individual will collaborate closely with Rejuvenate Bio’s R&D, process development, quality, CMC, and clinical development groups to generate development candidates with the required efficacy and safety profiles that warrant further clinical development. This position is available on a remote basis and reports directly to the Chief Scientific Officer. Exact title, salary, and responsibilities will be determined based on level of experience.

RESPONSIBILITIES:

• Lead the strategy for preclinical and translational activities to support project, program, and platform objectives; responsible for budgets and timelines of these aspects of development.
• Guide the design, execution, and implementation of preclinical drug development programs to achieve proof-of-concept, efficacy, safety and PK for various scientific programs.
• Collaborate with R&D and clinical teams to translate preclinical POC observations into a clinical development plan including patient selection, safety and efficacy endpoints.
• Accountable for the translational biomarker strategy, bioanalytical assay development and transfer, clinical assay testing and analysis for all gene therapy programs.
• Design, execute, interpret and report the drug-related specialty clinical biomarkers of target engagement, PD, efficacy, immunogenicity and safety endpoint to support clinical trial.
• Present analyses and interpretations of preclinical studies to regulatory agencies and other oversight bodies in meetings; prepare nonclinical section of regulatory filings, including briefing packages, IND applications / CTAs, annual reports, safety reviews, etc.
• Coordinating external activities and collaborations with research institutions, grant agencies and CROs to advance Rejuvenate Bio’s nonclinical studies to first-in-human clinical studies.
• Build, retain and motivate a dynamic team of preclinical and translational scientific staff through recruitment, hiring and mentoring, including team performance management and development.
• Participate in and lead cross-functional project teams with R&D, Process Development, Analytical Development, CMC, and Clinical Development.
• Effectively communicate strategy, methodology, progress, and challenges to stakeholders and partners, including senior leadership and board of directors.
• Works with senior leadership and department directors to develop operational and capital budgets, manage budget priorities, allocate resources, and address and resolve budget issues across the organization.

Qualifications

• Ph.D. in Pharmacology, Toxicology, or a field of study relevant to Rejuvenate Bio’s platform and therapeutic focus areas. Equivalent experience may be considered for candidates with a B.S. or M.S. degree.
• 7+ years of drug discovery experience in the pharmaceutical and/or biotechnology industry, with at least 3 years of experience in gene therapy. Must demonstrate a consistent track record of achievement & career progression.
• Successful track record of building, leading, and managing scientific teams in preclinical and/or translational disciplines.
• Demonstrated expertise in gene therapy and the relevant regulatory expectations for Investigational New Drugs.
• Requisite and evidenced expert contributions and broad experience in executing and curating summaries for non-clinical / preclinical and supporting in vivo experiments and data for successful IND/NDA applications.
• Experience with canine/mouse/rat/porcine/non-human primate models to achieve proof-of-concept, efficacy, safety and PK for various scientific programs.
• Ability to establish and cultivate cross-functional collaborations both internally and externally, and lead and influence at all levels of the organization.
• Excellent written, verbal, interpersonal, and leadership skills.
• Flexible mindset, with the ability to change direction and grow as required to evolve the scientific direction of the company.
• Ability to anticipate and recognize ambiguous situations, and to assess risk and make decisions in uncertain situations.
• Ability to proactively define, plan, communicate and manage multiple initiatives simultaneously to achieve objectives.

Additional Information

BASE SALARY: $200k - $340k+; exact salary and job title will depend on experience.

EEO STATEMENT _Rejuvenate Bio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Rejuvenate Bio is an E-Verify Employer in the United States. All your information will be kept confidential according to EEO guidelines. _

THE HEALTH AND SAFETY OF OUR EMPLOYEES AND THEIR FAMILIES IS A TOP PRIORITY. The company encourages employees to remain up-to-date on their COVID-19 vaccinations. Rejuvenate Bio, Inc. employees may be required, in the future, to be vaccinated or have an approved disability/medical or religious accommodation.