Vice President, Clinical Pharmacology

Amylyx Pharmaceuticals•Cambridge, MA

5d•$330,000 - $342,000•Remote

About The Position

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply. The Vice President 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 development and, as applicable, through commercialization. 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. In addition, there will be opportunities to contribute to diligence assessments. Reporting directly to the SVP, 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.

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
You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

Responsibilities

Serve as the clinical pharmacologist for the company across all clinical programs, providing strategic and scientific input from preclinical development through Phase 3 trials
Lead the Clinical Pharmacology team accountability for the clinical pharmacology strategy for Amylyx' development portfolio from pre-IND through and post approval, including design and implementation of program specific clinical pharmacology studies, data analysis, internal decision points, and external regulatory interactions
Integrate 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
Ensure appropriate PK, PD and PK/PD data analyses (including population PK, PK/PD modeling and simulation) are conducted for each study/program.
Collaborates 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
Ensure adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
Serves as the clinical Pharmacology expert across study and program teams
Develops and implements new clinical pharmacology approaches to processes and clinical studies that impact development programs
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 and provides input into assay development, CRO selection and CRO management. Leads method development, method qualification, method validation activities as SME and sponsor monitor, as assigned.
Represents nonclinical and clinical pharmacology during meetings and discussions with regulatory authorities
Creates or guides nonclinical and clinical pharmacology summary documents
Reviews literature and peer-reviewed publications to keep apprised of global regulatory developments in clinical pharmacology; Authors/ reviews manuscripts for submission to peer-reviewed journals