THE OPPORTUNITY

The Head of Clinical Pharmacology will provide leadership and support to the clinical pharmacology team and be accountable for the overall strategy for determining the PK, PD, and immunogenicity properties of all drugs and drug candidates in neurological conditions. As the clinical pharmacology expert within the company, you have experience and expertise in matrixed leadership and team management, and will lead, develop, and educate through cross-functional teams. Reporting directly to the SVP, Global Head of Clinical Development you will have high visibility at leadership levels, including with the Chief Medical Officer. You can efficiently and effectively synthesize internal and external data to produce a clinical pharmacology strategy.

THE RESPONSIBILITIES

• Lead the Clinical Pharmacology team accountability for the clinical pharmacology strategy for Amylyx’ development portfolio from pre-IND to approval, including design and implementation of program specific clinical pharmacology studies, data analysis, internal decision points, and external regulatory interactions
• Integrates clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical, statistics, regulatory, nonclinical ADME, toxicology to support and impact development decisions
• Ensures appropriate PK, PD and PK/PD data analyses (including population PK, PK/PD modeling and simulation) are conducted for each study/program.
• Collaborate with toxicologist and preclinical pharmacology scientists to design, analyze, interpret, and report preclinical PK and translational PK/PD studies to support candidate selection and IND filing, including human PK prediction to support starting dose and dose escalation schemes for first-in-human studies
• Ensures adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
• Serve as the clinical Pharmacology expert across study and program teams
• Develop and implement new clinical pharmacology approaches to processes and clinical studies that impact development programs
• Contribute to program strategy, study design, protocol preparation, study execution, data review/analysis, study reports and regulatory document preparation
• Work closely with research and development teams and provide input into assay development, CRO selection and CRO management
• Represent nonclinical and clinical pharmacology during meetings and discussions with regulatory authorities
• Create or guide nonclinical and clinical pharmacology summary documents
• Review literature and peer-reviewed publications to keep apprised of global regulatory developments in clinical pharmacology; Author/ review manuscripts for submission to peer-reviewed journals

REQUIRED QUALIFICATIONS

• PhD, PharmD, MD, or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines
• Minimum 10 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 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

WORK LOCATION AND CONDITIONS

• This is a remote friendly role, but you must reside and work within the United States, and in a state where Amylyx currently does business, to be considered. Any change in your remote location must be approved by Amylyx
• You will be required to follow Amylyx’s Remote Work Policy which includes:  
  • traveling to our corporate location in Cambridge, MA several times a year and attending other company-related events as necessary and requested, which may include travel by air, driving, or public transportation.
  • working in a setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote location
  • Information security protocols and steps to maintain confidentiality of Amylyx information, technology, and materials.