Associate Director/Director of Pharmacology
The role will lead the in vivo pharmacology group at Frontera. It is an exciting opportunity for a self-starter with a successful track record in biotech. The successful candidate will guide therapeutic area project teams to select novel AAV development candidates in metabolic, cardiovascular and CNS diseases using disease models in our in-house facility and with CROs. Develops and mentors direct reports and provides leadership to the Company via participation in various governance committees. Responsible for employee development, administrative functions, and budgetary responsibilities related to pharmacology and drug development.
- Provides strategic leadership to achieve Frontera's mission, regulatory affairs activities, and operations for the portfolio of gene therapy products.
- Provide regulatory guidance throughout the research and development process.
- Identifies and evaluates regulatory risks and establish strategies to mitigate such risks.
- Prepares clear and compelling regulatory submissions on behalf of Frontera's portfolio, leveraging internal and external resources.
- Acts as the primary Frontera contact with regulatory bodies in the US and International.
- Design, implement, drive, and oversee pharmacology strategies.
- Collaborate with internal teams and external partners to execute on development program objectives.
- Contribute to development program strategy, study execution, data review/analysis, study reports, protocol preparation, and regulatory document preparation.
- Write and review non-clinical pharmacology and toxicology summary documents.
- Oversee vendors and consultants as appropriate to execute pharmacology studies.
- Report findings and advise the leadership team on preclinical safety and efficacy of development candidates.
- Lead the resolution of pharmacology-related queries from drug regulatory agencies, writing and reviewing responses to regulatory on pharmacology-related questions.
- Lead authorship for toxicology/pharmacology sections for all regulatory documents.
- Train, manage and mentor department groups in a team and goal-driven environment.
- Ph.D. in Pharmaceutical Sciences, DVM, MD, or related field is preferred. Extensive related professional experience may be substituted for a terminal degree
- At least 10 years of pharmaceutical/biotechnology industry research experience is required
- Excellent communication and organizational skills and attention to detail
- Strong time management skills and ability to prioritize multiple tasks efficiently
- Experience with FDA CTA/IND and BLA submissions and regulatory interactions
- Track record of pharmacology leadership on multiple development programs at early and late stages of development
- Experience with gene therapy products
- Ability to perform in a fast-paced, dynamic, continually evolving environment
- Extensive leadership experience and success in drug development and regulatory affairs
- Interpersonal skills to foster open communication
- Ability to coach and develop others and to act as a catalyst for positive change