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Lead for Nonclinical Strategy

2 months ago

Menlo Park, California, United States ReCode Therapeutics, Inc. Full time
Position Overview:

ReCode Therapeutics, Inc. is seeking a dynamic and experienced professional to take on the role of Head of Translational Sciences and Nonclinical Operations.

In this pivotal position, you will report directly to the Senior Vice President of Early Development, playing a crucial role in guiding the strategy for nonclinical and translational sciences. Your leadership will ensure alignment with clinical development objectives and navigate the regulatory landscape to facilitate clinical advancements and marketing authorizations.

Key Responsibilities:
  • Oversee strategic initiatives for Toxicology/Pathology, BioAnalytical/DMPK, Biomarkers, and Clinical Pharmacology teams, ensuring robust support for clinical development initiatives.
  • Deliver comprehensive data packages to regulatory bodies to assist in securing marketing approvals.
  • Work collaboratively with cross-functional teams to align nonclinical and translational science deliverables with clinical development strategies.
  • Develop contingency plans and alternative strategies to proactively manage unexpected challenges and mitigate potential impacts on timelines.
  • Design and implement strategic plans for nonclinical operations, anticipating potential hurdles and ensuring readiness to address them.
  • Maintain a proactive stance in adapting functional strategies to evolving scientific and regulatory environments, monitoring the regulatory and competitive landscape for the design of both standard and expedited global approval pathways.
  • Identify, engage, and manage consultants and external subject matter experts (SMEs) as necessary to refine and enhance functional strategies based on the latest scientific knowledge and regulatory requirements.
  • Foster collaborations with key opinion leaders and external partners to remain informed on advancements in translational sciences.
  • Guide subject matter experts in the preparation of CTD/CTA modules, providing direction in response to inquiries from health authorities and contributing to the development of briefing documents for health authority interactions as needed.
  • Lead as the program head for translational deliverables on significant programs and/or mentor program/project translational leads within a matrix environment.
  • Possibility to assume full (end-to-end) project team leadership roles for assigned programs based on capacity and interest.
Qualifications:

Advanced degree in life sciences or medicine (PhD/MD/PharmD preferred).

A minimum of 12 years of experience in the biopharmaceutical industry, specifically in non-clinical development (toxicology, pharmacology, pharmacokinetics, bioanalytical sciences, or related fields).

Strong understanding of scientific principles and drug development processes, with particular expertise in nonclinical study design, preclinical CROs, data management systems, nonclinical study methodologies, and statistical analysis techniques.

Extensive knowledge of GLP regulations, with prior GLP experience in the pharmaceutical or biotechnology sectors or equivalent GXP transferable experience.

Experience in rare diseases, genetic therapies, gene therapy, and/or lipid nanoparticles is a plus.

Comprehensive understanding of global regulatory standards, including FDA (CBER), EMA, MHRA, and other major regulatory agencies, with prior experience supporting regulatory submissions.

Exceptional communication and interpersonal skills, with the ability to collaborate effectively in a cross-functional, dynamic environment.

Demonstrated leadership capabilities, high scientific integrity, and the ability to positively influence cross-functional initiatives for optimal program outcomes.

Salary Range:

265-300K

*Note that for remote positions, salary adjustments may be applied based on the cost of living.