Role Summary

The Senior Director of Clinical Pharmacology will play a pivotal role in leading our clinical pharmacology efforts to advance the development of our cutting-edge antibody portfolio. This position requires a strategic leader who can integrate clinical pharmacology and pharmacokinetics/pharmacodynamics (PK/PD) strategies into our drug development programs to ensure efficacy, safety, and regulatory success.

Key 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.

Ideal Candidate

• 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. Experience with extended half-life biologics and/or combination products desirable.
• 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.

What We Offer

• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture of our young company, wear multiple hats, and learn quickly.
• Market-competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Flexible PTO
• Two, one-week company-wide shutdowns each year.
• Commitment to growing you professionally and providing access to resources to further your development.
• 100% remote team with frequent in-person meetings to build relationships and problem solve.

The expected salary range offer for this role is $255,000 to $300,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.