Associate Director/Director, Translational Study Management
- ReCode Therapeutics
- Menlo Park, California
- Start date
- Mar 16, 2023
- Clinical, Clinical Data, Science/R&D, Bioanalytical Services, Pharmacology, Toxicology, Pharmacokinetics
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Biotech Bay
Who We Are:
We are a clinical stage company powering the next wave of genetic medicine through superior delivery with our next-generation lipid nanoparticle delivery platform. Our mRNA and gene editing therapeutics have the potential to directly replace or address underlying genetic mutations in a vast range of diseases starting with primary ciliary dyskinesia and cystic fibrosis. Our selective organ targeting (SORT) LNP platform is uniquely differentiated to enable the delivery of diverse genetic payloads to tissues beyond the liver.
At ReCode, we bring a unique blend of rigor, creativity, and curiosity to our high-hurdle mission. Our team is uniquely positioned to tackle this challenge, given our extensive experience in lipid nanoparticle delivery, mRNA design and optimization, mRNA manufacturing, gene editing, and rare disease drug development. We are a high performing, highly functional organization with a culture that is caring and strives to enable every member of our team to thrive.
Summary of Position:
You are an experienced translational research manager/study monitor, with experience including but not limited to: nonclinical study design and protocol development, management and oversight of both Contract Research Organizations (CROs) and academic collaborators, coordination of test article shipping and document archiving, review of reports and study related communications for content and accuracy, authorship and review of regulatory submissions (IND, CTA), effective leadership and ability to drive clear communication/coordination across multiple functional areas and project teams. This position reports to the VP of Translational Science & Portfolio Strategy.
- Proactively leverage scientific, technical, and operational knowledge to support development and execution of nonclinical strategy and thereby directly contribute to enhancing the success of programs
- Acts as operational lead in Pharmacology Sub Teams and relevant non-project teams. Independently supports multiple programs with a strong ability to learn and understand disease indication, in vivo model systems, pharmacology and toxicology, clinical strategy, and target profile
- Manage all aspects of non-GLP (pilot, proof-of-concept) and GLP nonclinical pharmacology, toxicology and pharmacokinetic studies, with minimal supervision, as well as contribute to scientific study designs and resource management, including budget oversight
- Effectively manages, develops, tracks project timelines of preclinical outsourced studies. Independently edits and reviews documents for consistency, completeness, and accuracy
- Provide subject matter expertise and support regulatory filings, including co-authoring nonclinical sections with study synopsis, summaries, study references etc.
- Develop, track, and ensure adherence to study timelines, including close coordination with bioanalytical and manufacturing groups as needed to ensure successful study execution.
- Understands dynamic global CRO landscape and proactively leverages knowledge to address business needs.
- Understand business needs with respect to corporate goals, preclinical outsourcing strategies, GLP compliance, and welfare standards
- Provides support during regulatory inspections and internal functional group audits. Solid understanding of documents governing inspection readiness
- Develop and maintain relationships with study directors, principal investigators and other external collaborators, with occasional travel to CROs to monitor external study conduct and ensure technical quality
- May supervise, matrix manage, and/or mentor other employees
- Prepare and provide regular, relevant study updates to functional leads, project teams and senior leadership as appropriate.
- Education: Master’s degree or PhD in scientific-related field is preferred, and at least 8 years of experience (Director) or 5 years of experience (Associate Director) in toxicology, pharmacology, pharmacokinetics, bioanalytical sciences, or related discipline
- Strong understanding of science and drug development, with specific expertise in nonclinical study design, preclinical CROs, data management systems, nonclinical study procedures, and statistical analysis methods
- Comprehensive knowledge of GLP regulations, including previous GLP experience in pharmaceutical or biotechnology industry or equivalent GXP transferable experience
- General knowledge of manufacturing and bioanalytical requirements for GLP studies
- Detail oriented, with ability to multi-task and work with both individual contributors and teams
- Demonstrated a team player with excellent interpersonal and organizational skills
- Effective communicator, both verbally and in writing, and ability to facilitate open cross-functional collaboration
- High degree of self-organization, flexibility, attention to details, with a proactive attitude toward problem-solving and risk mitigation as well as an ability to influence and negotiate effective solutions
- Ability to prioritize across programs and effectively lead internal team members and external parties (CROs, etc.)
Salary Range: *
*170-190k- Please note that for remote positions, salary may be adjusted for cost of living
- No premium cost for employees - 100% subsidized by ReCode for full-time employees
- Company 401k contribution
- 15 days of company paid holidays, including a holiday shutdown (usually the last week of the year)
- Mental health support for employees & their families
- FSA available, including a lifestyle spending account subsidized by company
- Employee discounts at hotspots
ReCode Therapeutics (www.recodetx.com) offers a competitive compensation/benefits package with a friendly, collaborative culture that values employee engagement and ongoing career development.
ReCode Therapeutics is an Equal Opportunity Employer.
The Why Behind Our Work
We imagine a world where people living with genetic diseases can fully benefit from the promise of genetic medicines. Our novel mRNA and gene correction therapeutics have the potential to make this a reality.
Therapeutic Areas of Focus
Primary ciliary dyskinesia
Certain cancers and central nervous system (CNS) diseases
Power the Next Wave of Genetic Medicine
We are one of the rare companies whose innovations are poised to fundamentally shift an entire class of medicine.
Join us as we advance our pipeline into clinical development and scale ReCode’s next-generation genetic medicines delivery platform and pipeline.
1140 O'Brien Drive
Menlo Park, CA 94025
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