Senior Manager, Clinical Pharmacology

Key Responsibilities

• Offer scientific and strategic input into Therapeutic Area clinical pharmacology plans.
• Identify, develop, and carry out strategic clinical pharmacology activities.
• Aid in the development and validation of pharmacometrics models.
• Oversee CRO collaboration on clinical pharmacology projects.
• Conduct population pharmacokinetic and pharmacodynamic analyses.
• Provide pharmacometrics expertise to project teams.
• Collaborate with cross-functional teams to support the design and execution of clinical studies (early and late phase trials).
• Lead the development of the clinical pharmacology sections of clinical protocols and associated analysis plans.
• Prepare relevant sections and review regulatory submissions.
• Collaborate with academic institutions and key opinion leaders.

Experience & Skills

• PhD degree (in pharmacometrics, pharmaceutical sciences, or related field) preferred or equivalent relevant experience.
• 4+ years of progressive experience.
• Minimum of 4 years of experience in PK/PD modelling, preferably in biologics.
• Strong knowledge of pharmacokinetics and pharmacodynamics.
• Experience with population PK/PD modeling and simulation.
• Experience with NONMEM, R, or other pharmacometrics software.
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Prior experience of regulatory filings and knowledge of regulatory compliance processes specific to clinical pharmacology is preferred.

Work Environment

• Primarily desk-based, generally in an office or home office setting.
• May involve extended periods of sitting and computer use.