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About the Role

The Associate Director, Clinical Pharmacology will work within clinical development teams, taking significant responsibility for the Clinical Pharmacology package of multiple clinical and Pre-IND programs. This role involves formulating clinical pharmacology strategies from First-in-Human (FIH) through registration.

Responsibilities

• Provide expertise in the clinical development of small molecule programs, including the design and oversight of clinical pharmacology studies.
• Lead and manage the design and conduct of clinical pharmacology studies of increasing complexity.
• Analyze, interpret, and author documents for clinical submissions, such as clinical study protocols and reports, Investigator’s Brochures, and clinical pharmacology sections of regulatory submissions.
• Interact with regulatory agencies (US and ex-US) as needed.
• Be accountable for study-to-program level clinical pharmacology aspects of compounds from discovery to development.
• Oversee and interact with consultants and vendors supporting clinical pharmacology tasks, including PK, PKPD, and clinical assay development.

Requirements

• 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) is required.
• Ability to work independently in a dynamic and fast-paced environment.

Skills

• Strong interpersonal skills
• Ability to influence development program teams
• Excellent verbal and written communication skills
• Ability to clearly convey complex concepts to technical and non-technical audiences

Location

• Thousand Oaks, CA
• San Francisco, CA

Work Type

• Full-time

Experience Level

• Associate Director
• 8+ years

Education Level

• PharmD or PhD in a relevant discipline preferred

About the Company

• 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.