Director of Bioanalytical Sciences
Summary:
EPM Scientific is partnered with a rapidly growing biotech developing therapeutics to combat the effects of debilitating Central Nervous System and Infectious diseases with unmet need on the market.
The team is targeting talented individuals that can utilize their scientific leadership experience in bioanalytical efforts and preclinical/clinical operations, with broad experience in small molecule, protein, and oligonucleotide therapeutics. This individual will also be well versed in preparation and review for regulatory documentations to support the progression of their clinical and commercial candidates.
Responsibilities:
- To support R&D and corporate strategy, providing scientific and strategic leadership in bioanalytical sciences and preclinical/clinical operations.
- Supports research and development project teams across multiple therapeutic domains that include small molecule and protein therapeutics; and contributes to project strategies as the bioanalytical program lead.
- Create, implement, evaluate, and deliver data to internal project teams and top management.
- Oversee bioanalytical CROs to ensure quality data and reports are produced within specified timescales and to enable the transfer, development, and validation of regulated (GLP/GCP) bioanalytical methods.
- Contracts with CROs and bioanalytical parts of project costs are managed.
- Contribute to the development of study protocols, reports, and bioanalytical sections of regulatory submissions (e.g., IND, NDA, BLA) and respond to regulatory agency questions.
Qualifications:
- Supporting bioanalysis in preclinical and clinical trials with a master's or doctoral degree and at least ten years of experience in the pharmaceutical sector.
- Developed and validated bioanalytical and immunogenicity methodologies for small compounds and protein therapies.
- Bioanalytical sections of regulatory submission forms (e.g., IND, NDA/BLA) and bioanalytical components of nonclinical and clinical study protocols
- GLP/GCP regulations and regulatory guidance materials that apply to bioanalysis are well-versed.
- Excellent oral and written communication abilities
- Outstanding leadership abilities
- In a matrix organization, shown capacity to effectively influence without authority
- Demonstrated ability to allocate and deploy resources in accordance with project and business goals
