Amylyx Pharmaceuticals, Inc. logoAmylyx Pharmaceuticals, Inc. logo

Vice President of Clinical Pharmacology

Amylyx Pharmaceuticals, Inc.Cambridge, MA - Remote
Remote Full-time $330K/yr - $342K/yr

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Experience Level

Senior Level Manager

Qualifications

Key Responsibilities:Act as the clinical pharmacologist for all clinical programs, providing strategic and scientific guidance from preclinical development through Phase 3 trials. Lead the Clinical Pharmacology team, ensuring accountability for the clinical pharmacology strategy across Amylyx's development portfolio from pre-IND through post-approval, including designing and implementing program-specific studies, analyzing data, making internal decisions, and managing external regulatory interactions. Integrate clinical pharmacology insights with a comprehensive understanding of related disciplines, such as clinical, statistics, regulatory, nonclinical ADME, and toxicology, to influence development decisions. Ensure thorough PK, PD, and PK/PD data analyses (including population PK, PK/PD modeling, and simulation) for each study/program. Collaborate with toxicologists and preclinical pharmacology scientists to design, analyze, interpret, and report on preclinical PK and translational studies.

About the job

Amylyx Pharmaceuticals is on a bold mission to revolutionize the treatment of diseases with significant unmet needs. Where others see obstacles, we identify opportunities, approaching them with urgency, rigorous scientific inquiry, and an unwavering dedication to the communities we serve. As a clinical-stage organization, we are currently focused on conditions such as post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our commitment is fueled by our dynamic team. Our core values, be audacious, be curious, be authentic, be engaged, and be accountable, foster a culture of compassion and action. We have assembled a knowledgeable team poised to make an impact because the communities we support cannot afford delays. If you share our enthusiasm and are driven to tackle some of medicine’s most challenging issues, we invite you to explore this opportunity and apply.

The Vice President of Clinical Pharmacology will lead and support the clinical pharmacology team, overseeing the strategic direction for evaluating the pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity characteristics of all drug candidates in development, extending through commercialization when applicable. As the clinical pharmacology authority within the organization, you will leverage your matrixed leadership and team development skills to guide, mentor, and educate cross-functional teams. Additionally, you will have the chance to engage in diligence assessments. Reporting directly to the Senior Vice President and Head of Clinical Development, you will maintain a high profile within the leadership team, including interactions with the Chief Medical Officer. Your ability to synthesize both internal and external data will be crucial in formulating the clinical pharmacology strategy.

About Amylyx Pharmaceuticals, Inc.

Amylyx Pharmaceuticals is a forward-thinking clinical-stage company dedicated to addressing significant unmet medical needs through innovative science. Our team embodies our values and is driven by a shared commitment to making a meaningful difference in the lives of patients and their families.

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