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/industry experience in preclinical pharmacology and toxicology, and biotherapeutic development experience within the Biotechnology or similar industry
• 5+ years of management experience or team leadership experience

Skills: 

• Scientific knowledge around pharmacology and toxicology
• Proven track record in designing and executing non-GLP and GLP safety/pharmacology studies
• Demonstrated biotherapeutic development experience including regulatory filings and interactions; knowledge of GLP and regulatory guidance; gene therapy development experience is preferred
• Demonstrated experience in selection, review, and interaction with CROs/vendors to ensure quality, timeliness, and cost
• Demonstrated ability to supervise the development and execution of CRO/vendor supported studies
• Demonstrated ability to design and perform studies to support regulatory strategy for therapeutic advancement and registration
• Demonstrated skills in managing scientific projects/programs
• Demonstrated capability for scientific, creative, and strategic thinking, championing ideas for positions, and ability to present scientific data and concepts effectively
• Ability to communicate – orally, in writing, and via formal presentation
• Ability to resolve emerging issues using existing teams and/or an established network of expert consultants
• Good interpersonal skills with the proven ability to work in a matrix team environment

Base salary compensation range: $181,000/yr - $268,000/yr