Senior Director, Clinical Pharmacology

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Candidates must have experience in matrixed leadership and team management, with the ability to lead, develop, and educate cross-functional teams. The role requires expertise in determining the PK, PD, and immunogenicity properties of drugs and drug candidates. Experience in diligence assessments and synthesizing internal and external data to produce a clinical pharmacology strategy is necessary. A broad understanding and collaboration with disciplines such as clinical, statistics, regulatory, nonclinical ADME, and toxicology are essential.

Responsibilities

The Senior Director of Clinical Pharmacology will provide leadership and support to the clinical pharmacology team, overseeing the overall strategy for PK, PD, and immunogenicity. They will serve as the clinical pharmacologist for all clinical programs, offering strategic and scientific input from preclinical development through Phase 3 trials. Responsibilities include leading the clinical pharmacology strategy for the company's development portfolio, designing and implementing clinical pharmacology studies, conducting data analysis, and managing internal decision points and external regulatory interactions. The role involves ensuring appropriate PK, PD, and PK/PD data analyses, collaborating with toxicologists and preclinical pharmacology scientists, and representing the company during regulatory authority meetings.

Skills

Clinical Pharmacology

PK/PD

Immunogenicity

Drug Development

Preclinical Development

Phase 3 Trials

Matrixed Leadership

Team Management

Diligence Assessments

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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