Director, Pharmacology & Toxicology

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.

 

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.  

Company Differentiators: 

•    Fully integrated clinical-phase company with internal manufacturing
•    Demonstrated ability to move rapidly from idea to IND
•    Five candidate products in the clinic and two declared pre-clinical programs
•    Robust technology and IP foundation, including our TVE and manufacturing platforms
•    Initial product safety and efficacy data substantiates the value of our platforms
•    Opportunities to expand to other indications and modalities within genetic medicine

GENERAL SUMMARY

We are seeking an experienced and highly motivated Director of Preclinical Pharmacology & Toxicology with a proven record of sustained scientific achievement and innovation to join our growing Scientific Development team. The successful candidate will build and lead a newly formed Preclinical Pharmacology & Toxicology Department, and play a key leadership role in supporting 4DMT’s gene therapy programs in multiple therapeutic areas. The role will be responsible for developing and executing strategies for in vivo pharmacology and toxicology strategies, including being responsible for the quality and comprehensive data to support the nonclinical safety/pharmacology/toxicology section(s) for regulatory filings. This role will interact and collaborate with multiple functions at 4DMT, including but not limited to Technology & Innovation, Clinical Science, Biomarkers, and CMC, with broad responsibilities and opportunities for a large impact on the lives of gene therapy patients.

RESPONSIBILITIES:

Building and Leading the Preclinical Pharmacology & Toxicology Department: 20% of TIME:

• Developing strategies and directions for the department
• Building the team and functional capabilities through hiring internally and networking externally
• Establishing and building collaborations with relevant functions at 4DMT
• Managing budget and headcount

Project Responsibilities: 50% of TIME:

• Lead preclinical pharmacology & toxicology for 4DMT’s gene therapy programs in discovery and development stages
• Represent preclinical toxicology on project teams and interface with internal stakeholders in discovery and development, as well as interface with regulatory agencies
• Oversight of design, analysis, and interpretation of preclinical pharmacology and toxicology data; summarize and communicate findings, as well as provide guidance
• Spearhead investigative efforts to elucidate the mechanism of toxicity as needed
• Author high-quality regulatory documents including IND, CTA, BLA, NDA, IB
• Participate in the preparation of abstracts and manuscripts for publication
• Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations

CRO, Consultant Oversight and Other Business: 30% of TIME:

• Accountable for CRO selection and oversight for outsourced work
• Manage collaborations with CROs and consultants to support non-GLP and GLP studies
• Stay up to date of regulatory requirements for gene therapy products; stay apprised of changing regulatory landscape; influence health authorities when possible
• Contribute to CDO’s vision and mission as a senior member of the group
• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

QUALIFICATIONS: 

Education: 

• PhD. in Toxicology, Biology, Pharmacology, or other relevant fields 

Experience: 

• 10+ years of professional/industr