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Full-Time

Head – Clinical Pharmacology

Confirmed live in the last 24 hours

Amylyx Pharmaceuticals

Amylyx Pharmaceuticals

201-500 employees

Develops treatments for neurodegenerative diseases

Healthcare
Biotechnology

Senior, Expert

Remote in USA

Must reside and work within the United States in a state where Amylyx currently does business.

Category
Physicians & Surgeons
Medical, Clinical & Veterinary
Required Skills
Communications
Data Analysis
Requirements
  • 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
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
Amylyx Pharmaceuticals

Amylyx Pharmaceuticals

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Amylyx Pharmaceuticals develops treatments for neurodegenerative diseases, focusing on conditions like Amyotrophic Lateral Sclerosis (ALS) and Alzheimer's Disease (ALZ). Their main product, AMX0035, is currently undergoing clinical trials to assess its effectiveness. The CENTAUR ALS trial showed promising results for ALS patients, using a randomized, double-blind, placebo-controlled design to ensure reliable outcomes. They are also conducting the PEGASUS trial to evaluate AMX0035's safety and effectiveness in Alzheimer's patients. Unlike many competitors, Amylyx emphasizes community engagement and awareness campaigns, such as ALS Awareness Month, to educate the public and foster support for those affected by these diseases. The company's goal is to bring effective therapies to market that improve patient outcomes.

Company Stage

IPO

Total Funding

$548.9M

Headquarters

Cambridge, Massachusetts

Founded

2013

Growth & Insights
Headcount

6 month growth

-25%

1 year growth

-18%

2 year growth

24%
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Simplify's Take

What believers are saying

  • Successful acquisition of Phase 3-ready avexitide from Eiger could diversify Amylyx's pipeline and open new revenue streams.
  • Interim data from the Phase 2 HELIOS trial shows promising results for AMX0035 in treating Wolfram syndrome, indicating potential for broader applications.
  • The appointment of experienced professionals like Dr. Bernhardt Zeiher to the Board of Directors strengthens the company's leadership and strategic direction.

What critics are saying

  • The failure of the Phase III PHOENIX trial and subsequent market withdrawal of Relyvrio raises concerns about the efficacy of Amylyx's treatments.
  • A significant workforce reduction by 70% under a restructuring plan could impact company morale and operational efficiency.

What makes Amylyx Pharmaceuticals unique

  • Amylyx Pharmaceuticals focuses on neurodegenerative diseases like ALS and Alzheimer's, setting it apart from competitors with broader therapeutic areas.
  • The company's flagship product, AMX0035, has shown significant treatment benefits in rigorous clinical trials, including the CENTAUR ALS trial, which is a strong validation of its efficacy.
  • Amylyx's commitment to community engagement and awareness campaigns, such as ALS Awareness Month, enhances its brand and builds a supportive community around its cause.