Amylyx Pharmaceuticals

Senior Director, Clinical Pharmacology

Cambridge, Massachusetts, United States

Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries

Position Overview

  • Location Type: [Not Specified]
  • Job Type: [Not Specified]
  • Salary: [Not Specified]

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve.

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – create 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 determination, we encourage you to read the opportunity below and apply.

The Opportunity

The Senior Director 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.

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.
  • 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-review.

Company Information

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve.

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – create 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 determination, we encourage you to read the opportunity below and apply.

Skills

Clinical Pharmacology
PK
PD
Immunogenicity
Data Synthesis
Team Leadership
Cross-functional Collaboration
Diligence Assessment

Amylyx Pharmaceuticals

Develops treatments for neurodegenerative diseases

About Amylyx Pharmaceuticals

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 and enhance the quality of life for individuals suffering from neurodegenerative conditions.

Cambridge, MassachusettsHeadquarters
2013Year Founded
$166.7MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
51-200Employees

Benefits

Remote Work Options

Risks

Relyvrio's Phase III failure raises concerns about ALS treatment efficacy.
Low stock offering price suggests potential financial instability.
New CCO may disrupt commercialization strategies if not aligned with goals.

Differentiation

Amylyx focuses on neurodegenerative diseases like ALS and Alzheimer's.
AMX0035 is a promising drug for ALS and Alzheimer's treatment.
Amylyx engages in community awareness campaigns for neurodegenerative diseases.

Upsides

Positive Phase II results for AMX0035 in ALS boost its potential.
Partnership with Gubra accelerates drug development for neurodegenerative diseases.
Regulatory support for rare diseases aids Amylyx's Wolfram syndrome efforts.

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