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Head of Translational Science
Location: Hybrid (Hatfield, PA) 
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Code Bio is seeking a motivated, flexible, experienced, 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 pipeline and oversee work with external collaborators. This individual will be supported by project management, and collaborate closely with Code Bio’s platform development, process development, and CMC groups to generate development candidates with the required efficacy and safety profiles that warrant further clinical development. This position reports directly to the Chief Scientific Officer.

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Responsibilities

  • Execute the strategy for preclinical and translational activities to support discovery and program objectives through IND; responsible for establishing and executing preclinical/early development plans, corresponding budgets, and timelines, working collaboratively with project management to ensure integrated plans.

  • 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 Platform, R&D and Regulatory 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.

  • Coordinate external activities and collaborations with research institutions, grant agencies and CROs to advance Code 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, supported by Project Management, R&D, Process Development, Analytical Development, CMC, Clinical Development, Regulatory, and New Product Planning.

  • 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.

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Education and Experience 

  • Ph.D. in Pharmacology, Toxicology, or a field of study relevant to Code Bio’s proprietary platform and therapeutic focus areas.

  • 5+ 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.

  • 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.

  • Skilled in clearly conveying complex concepts and study results in written and verbal form to a range of audiences, such as peers, executive management, regulatory agencies, and intellectual property attorneys.

  • Highly motivated, ethical, and professional self-starter with strong interpersonal skills and a quality and sense of urgency mindset, who is capable of influence and negotiation with stakeholders to successfully prosecute the completion of projects per timeline.

  • Demonstrated motivational leadership leading teams with an ability to articulate vision and successfully drive execution.

  • Flexible and comfortable with a fast-paced and evolving business environment.

  • Excellent communication skills.

  • Positive interpersonal skills with the ability to interact with individuals from a variety of levels and functions. Leads by example.  

  • Responsive, can-do attitude.

 

We offer a competitive salary and benefit package, including an employer matched 401k. Code Bio is proud to be an Equal Opportunity Employer.

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Interested individuals should send a cover letter and CV to careers@codebiotx.com or:

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