Annexon Biosciences is a clinical-stage biopharmaceutical company pioneering the development of a new class of medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders. The company’s pipeline is based on its platform technologies addressing a broad spectrum of well-researched classical complement-mediated autoimmune and neurodegenerative diseases triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entire classical complement pathway. Annexon is deploying a disciplined, unbiased biomarker-driven strategy designed to improve the probability of technical success of its portfolio and striving to deliver precision medicine to patients with classical complement driven diseases in the body, brain and eye.
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 Bio is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Employment is conditioned upon full vaccination 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.
Recruitment & Staffing Agencies: Annexon Bio does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Annexon Bio or its employees is strictly prohibited unless contacted directly by the HR Team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Annexon Bio, and Annexon Bio will not owe any referral or other fees with respect thereto.