Head of Preclinical Development
Start Date: Immediate
The position in in Modi'in
The Head of Preclinical Development will lead the Preclinical Development. In that role, he/she will be responsible for strategic planning, execution and reporting of pre-clinical pharmacology and toxicology studies. The candidate must have experience and proven success in regulatory submissions (e.g. IND and NDA/BLA, and/or MAA submissions) and must be able to represent the Company to a broad range of external stakeholders including regulators, scientific experts, potential development partners and experts in the field.
Responsibilities will include:
- Lead the strategic design and execution of preclinical pharmacology and toxicology/toxicity programs in order to be able to submit INDs and NDA in collaboration with a range of internal and external partners, including scientific and academic experts, research laboratories, consultants, co-development partners, and CROs.
- Work closely with clinical pharmacology, pharmacometrics and bioanalytics groups to ensure robust PK/PD data is generated to support dose selection for clinical programs, and ultimately NDA/BLA/MAA approvals.
- Lead and work with CROs in assessing PK, PK/PD, target engagement, biomarkers and toxicology, and establish the safety profile for preclinical development
- Partner with clinical pharmacology, pharmacometrics, bioanalytics and safety groups to conduct safety pharmacology and phamacodynamics and lead toxicity/safety assessment (e.g. for IND submissions).
- Generate comprehensive reports that assess the pharmacologic/toxicologic profile of drug candidates, and investigate toxicity relationships
- Serve as Preclinical Development subject matter expert on project teams. Provide clear updates of Preclinical study design, execution and results relevant to project team programs. Keep abreast of novel scientific developments in the field and share new information with project team and management as appropriate.
- Manage and oversee CROs in the design, conduct, analysis and interpretation of pharmacology and toxicology studies and ensure that studies are delivered within agreed quality, cost and timeline parameters.
- Ensure all preclinical development activities are conducted in line with regulatory standards and guidelines
- Present analyses and interpretations of studies to regulatory agencies in meetings and documents including IND, annual reports, investigator brochures, special protocol assessments and market applications
- Lead interactions with regulators regarding Preclinical Development and author relevant sections of regulatory submission documents (e.g. INDs, NDA/BLA, MAAs) as well as preclinical sections of Investigator Brochures, CTA applications, IMPDs, etc).
- Represent the Company externally at scientific meetings, regulatory agency meetings, grant defense and review meeting, partner interactions and with external experts, KOLs and other stakeholders.
- Develop nonclinical safety evaluation strategy across the entire portfolio, including evaluation of in-licensing opportunities
- Provide expert opinion on non-clinical safety and risk assessment to senior management
- Develop and oversee toxicology budgets
- PhD in toxicology or related field (DABT preferred) or DVM/DACVP
- Minimum of 10 years of relevant industry experience
- Expertise in technical, scientific, and regulatory aspects of nonclinical safety evaluation
- Comprehensive understanding of the interplay between toxicology, pharmacology, biomarkers, drug metabolism and pharmacokinetics, and formulations
- In depth understanding and experience in the design, development, conduct and interpretation of non-clinical toxicology and safety pharmacology studies.
- Experience with investigative toxicology, including proven ability to research and develop strategy around novel findings
- Experience on regulatory agencies relevant guidelines
- Proven ability to design, manage and interpret outsourced toxicology studies
- Experience interacting with worldwide regulatory agencies
- Proven success in supporting cross-functional project teams
- Proven ability to collaborate in a cross-functional matrix organization
- Highly effective verbal and written communication skills. Ability to ask insightful questions. Able to influence others in a positive manner
- Ability to create innovative strategies
- English and Hebrew at mother tongue levels
Please email CV to hr@BioLineRx.com