Position/Job Title: Director, Preclinical Development
Reports to: Senior Director, Bioanalytical Research & Translational Medicine
Status (FTE/PTE): Full Time
The Director of Preclinical Development is a recognized expert in nonclinical Pharmacology and Toxicology. The incumbent is responsible for the Toxicology/Pharmacology function by providing leadership and expertise for the development of Gene Therapy drug candidates from late-stage research through the nonclinical development process. The role also plays a critical role for all phases of the drug development process including clinical development, regulatory submissions and commercialization.
The Director will lead the strategic preclinical development of gene therapy drug candidates by managing a group whose mission includes:
Design, execute, and interpret nonclinical studies conducted in multiple species under non-GLP and GLP conditions, depending on their objectives.
Generate comprehensive reports that assess the pharmacologic/toxicologic profile of drug candidates, and investigate toxicity relationships.
Present studies’ analysis and interpretations to regulatory agencies in meetings and documents including the IND/CTA, annual reports, investigator brochures, special protocol assessments and market applications.
Work collaboratively with internal and external cross-functional sub teams, and collaborators/consultants to plan and execute the overall development of drug candidates from research to post market application.
The Director, Preclinical Development will be responsible for the planning, implementation and organization of nonclinical studies along with the use of drug exposure to bridge across species, presentation of data (written and verbal) to cross-functional core teams and sub teams, external collaborators, and the scientific community. This individual will lead or actively participate in representing Preclinical Development Dept on cross-functional project teams and/or project sub teams. This individual will also participate in program initiatives that further the business objectives of the company.
Develops and executes an overall Pharm/Tox strategy for the nonclinical development plans in support of all stages of drug development
Oversees and leads all Pharm/Tox activities from in vitro to in vivo studies supporting first in human (FIH) evaluation and throughout the development process, including study proposals, protocols, reports, interactions and collaborations with internal stakeholders and external vendors and/or collaborators, regulatory documents and post approval efforts.
Ensures that all preclinical development activities are conducted in line with the appropriate quality and regulatory standards and guidelines (e.g., FDA, CHMP, WHO, GLP, etc).
Ensures that all interdependencies within the Pharm/Tox process (e.g. Bioanalytical, CMC and Quality and Clinical) are aligned and the Pharm/Tox function is fully prepared to support the execution of each study.
Effectively communicates nonclinical findings and their relevance to senior management, project teams, collaborators, and regulatory agencies.
Participates in multi-disciplinary drug development teams and leads sub-teams
As part of the R&D management team, ensures optimal integration of the Preclinical Development group with other function within R&D or outside (Clinical, Technical Operations, Regulatory, Business Development), and provides support as needed.
Hires and manages staff, provides training and development opportunities as needed, and ensures adherence to company policies and quality requirements.
Serves as an in-house consultant.
Synthesizes multiple data sources and draws general, non-obvious conclusions.
Defines complex problems, develops approaches and develops experiments with sound judgment.
May independently represent the Company to outside organizations.
Puts work practices in context with larger team and participates in the implementation of change when required.
May assist with designing and implementing organizational processes, budgetary and capital equipment requirements, and identifies needs for additional resources.
Performs additional tasks or assist with special projects as assigned or needed.
SKILLS, KNOWLEDGE AND ABILITIES REQUIRED
PhD in Pharmacology, Toxicology or closely related field with a minimum of 10 years of nonclinical experience in the pharmaceutical/biotechnology industry. Equivalent experience may be accepted.
A minimum of 5 years of management experience supervising laboratory personnel.
Strong technical competency, organizational and prioritization skills.
Demonstrated ability to analyze and resolve problems.
Must possess excellent oral and written communication skills.
Ability to present technical information to both technical and non-technical audience is required.
Must be able to demonstrate sound judgement.
Must be able to demonstrate good interpersonal skills.
Ability to build and foster cross-functional collaborations both within and external to the organization.
Established ability to interact with various regulatory agencies
Demonstrated knowledge of regulatory agency guidance documents and white papers
Prior experience working in regulated environment and strong understanding of GLP
Veterinarian pathology experience strongly preferred
Strong understanding of drug development.
Established Drug Development Reputation
Experience to support development of gene therapy products or biologics
Strong understanding of FDA and OECD Good Laboratory Practices
WORKING CONDITIONS AND/OR PHYSICAL REQUIREMENTS
Normal working conditions
Supervisory responsibility of a team of 5-10 scientists/research associates
An equal employment opportunity employer. We are committed to providing equal employment opportunities to all qualified individuals without regard to the following legally protected characteristics: race, color, religion, sex, pregnancy (including childbirth, lactation and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military/veteran status, or any other characteristic protected by local, state or federal law. We assure you that your opportunity for employment depends solely on your qualifications.