Associate Director, Clinical Pharmacology

Primary Responsibilities

• Provide expertise in the clinical development of small molecule programs, including 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, such as 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.
• Be accountable for study-to-program level clinical pharmacology aspects of compounds in the discovery to development stage.
• Oversee and interact with consultants and vendors assigned to support clinical pharmacology tasks including PK, PKPD, and clinical assay development.

Qualifications And 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.
• Experience in the design and conduct of multiple types of Phase 1 studies (e.g. FIH, DDI, FE, rBA, etc.) preferred.
• Proficiency with modern PK analysis software (e.g. Phoenix WinNonLin) required.
• Knowledge of regulatory requirements for clinical pharmacology preferred.
• Strong interpersonal skills, and ability to influence development program teams.
• Excellent verbal and written communication skills, and ability to clearly convey complex concepts to technical and non-technical audiences preferred.
• Ability to work independently in a dynamic and fast-paced environment.
• Experience in therapeutic areas related to pain management preferred.
• Experience with regulatory submissions in early and late development is preferred.

Benefits

The company offers competitive compensation and benefits tailored to the needs of its employees. Details are provided in the job offer upon acceptance of employment.

Schedule

The position offers a flexible schedule to accommodate the needs of both the employee and the company.

Pay

The salary range for this position is $120,000 - $150,000 annually, commensurate with experience.