Director, Clinical and Translational Development
NateraSalary not specified
- Full Time
- Senior (5 to 8 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries
Requirements
Candidates should possess a Bachelor’s degree in Biological Sciences and a minimum of 7 years of relevant experience, or an advanced degree (PhD, PharmD) with fewer years of experience. Previous experience with immunology of the liver and/or neurology, particularly in the context of rare diseases, is preferred. A thorough understanding of nonclinical and clinical data requirements, including regulatory guidance, to support drug development is required, as well as experience authoring and supporting regulatory filings (INDs, NDAs, MAA, DSURs, IBs, etc).
Responsibilities
The Senior Manager of Translational Pharmacology will lead the design and execution of nonclinical plans (bioanalytical, animal efficacy, clinical biomarkers) for all Mirum assets, authoring and completing relevant sections of IND, NDA, MAA, and other regulatory documents in collaboration with Regulatory. They will oversee the outsourcing of nonclinical and bioanalytical studies, review resulting data, and communicate findings to teams. The role involves providing input on clinical trial protocols, overseeing CROs to ensure assay development and data transfers meet project goals, representing the pharmacology and translational arena with regulatory agencies, and playing a key role in due diligence efforts for potential licensing opportunities, including reviewing existing data and developing strategy.
Skills
Bioanalytical
Animal Efficacy
Clinical Biomarkers
Regulatory Documents
CRO Oversight
Immunology
Liver Immunology
Neurology
Rare Disease
Data Review
Assay Development
Data Transfers
Technical Oversight
Acadia Pharmaceuticals
Develops therapies for neurological disorders
About Acadia Pharmaceuticals
Acadia Pharmaceuticals develops therapies for neurological disorders, focusing on conditions like Parkinson's disease, schizophrenia, and Rett syndrome. The company conducts extensive research and clinical trials to create drugs that are safe and effective, seeking approval from regulatory bodies like the FDA before bringing them to market. Acadia differentiates itself by targeting areas with significant unmet medical needs, ensuring that their products address critical health challenges. Their goal is to improve the quality of life for patients suffering from these disorders while also promoting diversity, equity, and inclusion within their operations.
Key Metrics
Dallas, TexasHeadquarters
1993Year Founded
$813.4MTotal Funding
ACQUISITIONCompany Stage
Biotechnology, HealthcareIndustries
501-1,000Employees