Associate Director/ Director, Clinical Pharmacology
Reporting to the VP, Clinical Pharmacology, we seek a Phd or PharmD with experience leading the design and execution of Clinical Pharmacology and M&S strategies for biologics and small molecules.
- Responsible for the design and implementation of the Clinical Pharmacology and Modeling & Simulation (M&S) strategies for biologics and small molecules from pre-IND and FIH studies to pivotal Ph2/3 clinical studies.
- Apply/guide cutting-edge M&S approaches to ensure development of safe and effective dosing regimens for various patient populations & ensure optimal drug development.
- Analyze, interpret, summarize and present data to internal project teams, senior management and global health authorities.
- Develop clinical study designs, study protocols, amendments and reports.
- Contribute towards development of IND/CTA filings, including BLA/NDA submissions and other regulatory documents
- PhD in pharmacokinetics or pharmaceutical sciences, or PharmD
- 6y+ of relevant experience in Clinical Pharmacology in the pharmaceutical industry (level commensurate with experience)
- Experience in leading the design and execution of Clinical Pharmacology and M&S strategies for biologics and small molecules
- Excellent critical thinking, scientific and interpersonal skills, including a demonstrated ability to analyze, interpret and report complex PKPD data
- Proven ability to work/collaborate in a matrix environment and develop relationships with key stakeholders
- Excellent written/oral communication and presentation skills
Annexon’s Associate Director/ Director, Clinical Pharmacology will be required to be fully vaccinated against the Covid-19 virus. An applicant is considered fully vaccinated two weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine. You will be required to show proof of vaccination status upon hire. The Company provides reasonable accommodations in accordance with applicable state, federal and local laws.
Annexon is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.