Vice President, Clinical Pharmacology
vor 2 Monaten
Company: At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye.
Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases.
With proof-of concept data in Guillain-Barré syndrome, Huntington's disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible.
At Annexon, you'll be part of a team committed to making an impact together.
For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline.
We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.
We're seeking exceptional talent from all backgrounds to fuel our growth.
At Annexon, we're building a diverse, equitable, and inclusive workplace.
We value unique perspectives and unconventional paths.
If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply.
Position:
The Vice President, Clinical Pharmacology, reporting to the CMO, is responsible for developing and executing the overall clinical pharmacology strategy for Annexon's portfolio.
This role involves designing and implementing pharmacokinetic, pharmacodynamic, and modeling & simulation studies and integrating data from a variety of sources to support clinical and regulatory decisions, while collaborating with cross-functional teams to drive drug development through all phases.
The ideal candidate will have a PhD or MD, extensive industry experience, and proven leadership in clinical pharmacology, ensuring high standards of compliance, ethics, and scientific excellence.
Responsibilities include:
Designs and implements asset or program-specific clinical pharmacology studies, data analysis, internal decision points, and external regulatory interactions.
Leads the development and execution of comprehensive pharmacokinetic, pharmacodynamic, and modeling and simulation studies to inform clinical and regulatory decisions through all phases of drug development.
Works closely with cross-functional teams to provide and source subject matter expertise in clinical pharmacology, physiology-based pharmacokinetic modeling, model-based drug development, and quantitative systems pharmacology to inform topics such as drug mechanism of action and cross-species data translation, population responses, dose and regimen optimization, pediatric development, translation across ethnicities and geographies, among others.
Contributes to program strategies, study designs, protocol preparation, study execution, data review and analysis, study reports, and regulatory document preparation in all phases of development.
Collaborates with research and development teams and provides input into assay development as well as CRO and vendor selection and management.
Collaborates with late-stage teams to support the implementation of commercial strategies such as label extensions, formulations advancement, or advanced delivery systems.
Represents clinical pharmacology teams during meetings and discussions with regulatory authorities.
Guides the development of clinical pharmacology summary documents.
Reviews literature and peer-reviewed publications to keep apprised of global regulatory developments in clinical pharmacology.
Maintains a high standard for good laboratory and clinical practices, compliance, and ethical standards.
Education, Experience, and Skills:
Required:
PhD (or MD) in pharmaceutical sciences or pharmacology with 15+ years of direct experience in development and Clinical Pharmacology expertise or a PharmD with 15+ years of experience in the industry.
A broad understanding of drug development as evidenced by a track record of significant contributions to successful patents, INDs/CTAs, Regulatory Agency interactions, NDAs/BLAs/MAAs, business development activities, and peer-reviewed publications.
Demonstrated success in establishing and leading a high-performing clinical pharmacology team, with experience in organizational design, outsourcing strategies, and the recruitment, development and retention of top-tier talent.
Comfortable in an entrepreneurial, fast-paced, and challenging environment where leaders take a hands-on approach, with the proven ability to thrive in a rapidly evolving company.
Demonstrated expertise in writing, presenting, and discussing clinical pharmacology with internal and external stakeholders.
Strong analytical skills and the ability to interpret complex data sets are essential, along with demonstrated expertise in applying critical thinking to drive informed decision-making.
Must have a proven ability to work collaboratively in cross-functional teams, effectively manage multiple projects, and incorporate diverse perspectives while fostering strong relationships.
A proven ability to work with a high level of integrity, accuracy, and attention to detail is essential.
Requires effectively prioritizing and executing corporate objectives and goals.
Preferred:
Residence in the SF Bay Area.
Biotechnology and large pharmaceutical experience.
Location: This is an on-site position located at Annexon Headquarters in Brisbane, California.
Salary Range: $320,000 to $355,000.
Benefits:
A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
Our headquarters is in Brisbane, CA, with a shuttle service from BART, CalTrain and the Ferry.
Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, as well as other benefits.
Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.
We are committed to fostering an environment where ALL people are welcome and supported.
We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences.
We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results.
Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.
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