Senior Director, Clinical Pharmacology
Amylyx PharmaceuticalsSalary not specified
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, BiologicsIndustries
Requirements
A PhD or PharmD with relevant expertise in clinical pharmacology or pharmaceutical science is required, along with at least 5 years of direct industry experience in conducting clinical stage drug development. Experience in developing clinical pharmacology plans and authoring relevant sections of regulatory documents is also necessary.
Responsibilities
The Director, Clinical Pharmacology will lead clinical pharmacology programs in immunology and inflammation, providing strategic planning for drug development activities from first-in-human through approval. This includes developing and implementing quantitative approaches, collaborating with cross-functional teams and external partners, and leading the analysis, interpretation, and reporting of clinical PK/PD data. Responsibilities also include authoring clinical pharmacology sections of regulatory documents, maintaining an understanding of relevant scientific literature and methodologies, and supporting pediatric development efforts.
Skills
Clinical Pharmacology
Drug Development
Quantitative Pharmacology
Immunology
Inflammation
Strategic Planning
Biologics
Antibody Engineering
Abata Therapeutics
Develops therapies for autoimmune diseases
About Abata Therapeutics
Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.
Cambridge, MassachusettsHeadquarters
2021Year Founded
$184.8MTotal Funding
EARLY_VCCompany Stage
BiotechnologyIndustries
11-50Employees
Risks
Intensifying competition from companies like Sangamo Therapeutics may impact Abata's market share.
Stringent FDA scrutiny on manufacturing could delay Abata's clinical trials.
Rising clinical trial costs pose financial risks to Abata's pipeline progression.
Differentiation
Abata focuses on Treg cell therapies for autoimmune diseases like MS and diabetes.
Their lead product, ABA 201, targets type 1 diabetes with remaining beta cell function.
Abata's strategic partnership with ElevateBio enhances their manufacturing capabilities.
Upsides
Recent investment from Bristol Myers Squibb boosts Abata's Treg therapy pipeline development.
FDA's accelerated approval pathways may expedite Abata's clinical trials.
Growing autoimmune disease prevalence increases demand for Abata's innovative treatments.
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