Associate Director, Clinical Pharmacology

Latigo Bio • San Francisco, CA

1d • $205,000 - $235,000 • Onsite

About The Position

Latigo Biotherapeutics, Inc. is a private, early-stage biotechnology company focused on discovering and developing the next generation of non-opioid medicines for pain and pain-related syndromes. Our mission is the development of novel therapies that transform the lives of patients. We have a robust pipeline with programs ranging from preclinical to late phase. The company, whose headquarters is in Thousand Oaks, CA, with a satellite office in San Francisco, CA, has a highly successful management team as well as an experienced Board of Directors. At Latigo, we value honest science, patient-focus, and innovation.

Reporting to the Head of Clinical Pharmacology, the Associate Director, Clinical Pharmacology will work in our clinical development teams, with significant responsibility for the Clinical Pharmacology package of multiple clinical and Pre-IND programs. In this role, you will help formulate clinical pharmacology strategies from the FIH through registration.

Requirements

• PharmD or PhD in a relevant discipline preferred.
• 8+ years of experience in Clinical Pharmacology supporting early development in a biotech or pharmaceutical organization.
• Prior, robust clinical pharmacology experience with small molecules is required.
• Proficiency with modern PK analysis software (e.g. Phoenix WinNonLin) required.
• Strong interpersonal skills, and ability to influence development program teams.
• Ability to work independently in a dynamic and fast-paced environment.

Nice To Haves

• Experience in the design and conduct of multiple types of Phase 1 studies (e.g. FIH, DDI, FE, rBA, etc.) preferred.
• Knowledge of regulatory requirements for clinical pharmacology preferred.
• Excellent verbal and written communication skills, and ability to clearly convey complex concepts to technical and non-technical audiences preferred.
• Experience in therapeutic areas related to pain management preferred.
• Experience with regulatory submissions in early and late development is preferred.

Responsibilities

• As part of the development team, you will provide expertise in the clinical development of small molecule programs, in particular the design and oversight for clinical pharmacology studies.
• Lead and manage design and conduct of clinical pharmacology studies of increasing complexity.
• Analyze, interpret and author documents for clinical submissions, including but not limited to clinical study protocols and reports, Investigator’s Brochures, and the clinical pharmacology sections of regulatory submissions.
• Interact with regulatory agencies (US and ex-US) as needed.
• You will be accountable for study-to-program level clinical pharmacology aspects of compounds in the discovery to development stage.
• You will be responsible for oversight and interaction with consultants and vendors assigned to support clinical pharmacology tasks including PK, PKPD, and clinical assay development.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree