Senior Lead, Clinical Pharmacology (Small Molecules)

Xtalks; San Francisco (CA); Presencial; USD 180.000 - 260.000; Jornada completa

Descripción de la vacante

Latigo Biotherapeutics is recruiting an Associate Director, Clinical Pharmacology to guide clinical pharmacology strategies from FIH through registration. You will lead studies, interpret data, and support submissions within an integrated clinical development team.

The role requires strong communication, independence, and experience with small molecule programs and regulatory submissions in biotech/pharma environments.

Formación

• PharmD or PhD in a relevant discipline preferred.
• 8+ years of experience in Clinical Pharmacology supporting early development.
• Experience in design and conduct of multiple Phase 1 studies (e.g. FIH, DDI, FE, rBA).
• Proficiency with PK analysis software (Phoenix WinNonLin) required.
• Knowledge of regulatory requirements for clinical pharmacology preferred.

Responsabilidades

• Provide expertise in 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.
• Interact with regulatory agencies (US and ex-US) as needed.
• Oversee interactions with consultants and vendors for PK, PKPD, and clinical assay development.

Conocimientos

Clinical pharmacology

Small molecules

Phoenix WinNonLin

Regulatory submissions

Communication skills

Educación

PharmD/PhD

Herramientas

Phoenix WinNonLin

Descripción del empleo

Latigo Biotherapeutics is recruiting an Associate Director, Clinical Pharmacology to guide clinical pharmacology strategies from FIH through registration. You will lead studies, interpret data, and support submissions within an integrated clinical development team.

The role requires strong communication, independence, and experience with small molecule programs and regulatory submissions in biotech/pharma environments.