- Act as an expert consultant to advise the regulatory strategy planning of clinical pharmacology drug development programs.
- Review of our client’s data, models, and regulatory packages to offer guidance and support with submissions and responses.
- Proactively communicate with support teams on collaboration statuses and ensure key business milestones have been achieved.
- Partner with the Marketing team to develop business cases for external and cross-divisional promotion of clinical pharmacology regulatory consulting opportunities.
- Discuss and guide on software applications with clients and prospects on the telephone or in-person
- Play an integral role in developing ideas for generating income, promoting research areas, and influencing leading-edge practice to support large-scale collaborations for our software development strategies.
- Contribute to knowledge generation, knowledge exchange, and knowledge transfer activities in clinical pharmacology regulatory strategies utilizing PBBM/PBPK approaches.
- Mentor and educate colleagues with less experience on the latest clinical pharmacology guidance documents and engage with global regulatory agencies to promote and support the use of modeling and simulation to accelerate drug development programs.
- Develop ideas for software application based on cutting-edge research outcomes.
- Develop collaborative and productive relationships cross-functionally with scientists in drug development.
- Perform scientific peer reviews for modeling and simulation reports across divisions prior to submittals to clients or regulatory agencies.
- Write, review, and/or edit publications (manuscripts, abstracts, poster presentations, etc.) and grant applications.
- Attend and present at scientific conferences.
- Perform other related duties as assigned.
- This position reports to the Vice President, Regulatory Strategies.
S. or Ph.D. in Pharmaceutical Science, Biology, Biochemistry, Chemistry, or related fields.
- Minimum of 7 years experience as a regulatory consultant, liaison, reviewer, or related.
- Experience with dossier compilation, submission, and approval process in 1 or more major geographical regions.
- Solid knowledge of FDA, EMA, and other global regulations/regulatory requirements and ICH guidelines.
- Established a network of contacts and strategic partnerships across the industry.
- Demonstrated growth mindset while interacting with colleagues and clients at all levels.
- Some travel required (<25%).
Lancaster, CA, though remote options will be considered.
Competitive base salary, merit-based bonus, and stock option grants.