Vice President, Clinical Pharmacology
Cambridge, Massachusetts, United States of America
Full Time
2 hours ago
$304,000 - $342,000 USD
No Visa Sponsorship
Key skills
LeadershipCommunicationCollaborationRemote Work
About this role
Role Overview
- Provide leadership and support to the clinical pharmacology team
- Serve as the clinical pharmacologist for the company across all clinical programs
- Lead the Clinical Pharmacology team accountability for the clinical pharmacology strategy for Amylyx' development portfolio
- Integrate clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines
- Ensure appropriate PK, PD and PK/PD data analyses are conducted for each study/program
- Collaborates with toxicologist and preclinical pharmacology scientists
- Ensure adherence to agreed timelines and budgets
- Serves as the clinical Pharmacology expert across study and program teams
- Develops and implements new clinical pharmacology approaches to processes and clinical studies
- Contributes to program strategy, study design, protocol preparation, study execution, data review/analysis, study reports and regulatory document preparation
- Works closely with research and development teams
Requirements
- PhD, PharmD, MD, or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines
- Minimum 12 years of experience within the pharmaceutical and biotechnology industry with 5+ years' direct experience in Clinical Pharmacology
- Experience in an array of molecules including biologics, small molecules and gene therapy
- Demonstrated experience in writing, presenting, and discussing clinical pharmacology with regulatory authorities as well as other external and internal stakeholders
- Strong analytical skills and ability to interpret complex clinical data sets as well as deep understanding of individual patient data coupled with excellent written and verbal communication skills
- Ability to work in cross-functional teams and manage multiple projects, engaging subject matter experts across functions to drive the execution of programs
- Strong technical proficiency in PK analysis (NCA and PopPK)
- Ability to work with an elevated level of integrity, accuracy, and attention to detail, while executing corporate objectives and goals
- Entrepreneurial, enjoys working in a fast-paced, small-company environment.
Benefits
- remote work opportunities within the United States
- corporate location visits several times a year
- access to work in a setting enabling all role requirements