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A bit about us:

We are a clinical stage biopharmaceutical company located in the San Francisco Bay area. We are focused on autoimmune, neurodegenerative and ophthalmic disorders.

Why join us?

Opportunity for growth
Exciting pipeline
competitive compensation, benefits package and more

Job Details

We are seeking a highly motivated and experienced Vice President of Clinical Pharmacology to join our team. As the VP of Clinical Pharmacology, you will be responsible for leading and managing the clinical pharmacology team, providing strategic direction and oversight for the development and implementation of clinical pharmacology plans for our biotechnology and pharmaceutical products. You will work closely with regulatory agencies to ensure that our products meet all regulatory requirements and will be responsible for driving the successful development and approval of new drugs.

Responsibilities:

  • Lead and manage the clinical pharmacology team, providing strategic direction and oversight for the development and implementation of clinical pharmacology plans.
  • Work closely with regulatory agencies to ensure that our products meet all regulatory requirements.
  • Drive the successful development and approval of new drugs.
  • Oversee the design, execution, and analysis of clinical pharmacology studies.
  • Develop and maintain relationships with key stakeholders, including regulatory agencies, academic researchers, and key opinion leaders.
  • Provide expert guidance on clinical pharmacology issues to cross-functional teams, including clinical development, regulatory affairs, and commercial teams.
  • Ensure that all clinical pharmacology studies are conducted in compliance with applicable regulations and guidelines.
  • Develop and implement clinical pharmacology strategies to support drug development programs from IND to NDA.

Qualifications:

  • PhD or MD in Clinical Pharmacology or related field.
  • 10+ years of experience in clinical pharmacology and drug development.
  • Prior experience in a leadership role is ideal
  • Strong understanding of regulatory requirements for drug development, including IND and NDA submissions.
  • Experience with drug approvals and post-marketing surveillance.
  • Excellent communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams.
  • Strong analytical and problem-solving skills.
  • Experience with MBDD (Model-based drug development) is a plus.
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