Senior Director, Clinical Pharmacology

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Requirements:

• Ph.D. in Pharmacology, Pharmaceutical Sciences, or related field, with a strong focus on clinical pharmacology.
• A minimum of 10 years of experience in clinical pharmacology within the pharmaceutical or biotechnology industry, with significant experience in antibody development.
• Proven track record of accomplishment in drug development, from early-stage research through to regulatory submission and approval.
• Extensive experience with regulatory submissions and interactions with health authorities, particularly the FDA and EMA.
• Strong analytical and problem-solving skills, with expertise in PK/PD modeling and simulation.
• Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions.

Responsibilities:

• Lead the strategic planning and execution of clinical pharmacology studies, including PK/PD modeling, dose-response analysis, and bioequivalence studies.
• Collaborate closely with cross-functional teams, including clinical development, non-clinical development, DMPK, regulatory affairs, and clinical operations, to ensure alignment and integration of clinical pharmacology principles throughout the drug development process.
• Oversee the development and implementation of modeling and simulation strategies to predict drug behavior, optimize dosing, and support clinical trial design.
• Provide expert guidance on clinical pharmacology topics to regulatory submissions and interactions with health authorities worldwide.
• Stay abreast of emerging trends and regulations in clinical pharmacology and antibody development to ensure Spyre Therapeutics remains at the cutting edge.