Dmpk And Bioanalysis Contractor

Summary

Join Syndax Pharmaceuticals as a Contractor, DMPK and Bioanalysis, and oversee all aspects of DMPK related to large molecule drug candidate development. You will design and execute preclinical studies, represent DMPK and bioanalysis as a subject matter expert, and analyze and report preclinical DMPK data. Collaboration with various teams and external vendors is crucial. You will author regulatory documents and contribute to publications. The ideal candidate possesses a BS/MS with 8+ years of experience or a PhD/PharmD with 3+ years of experience, along with strong DMPK and bioanalytical knowledge. This role offers the opportunity to significantly impact the development of potential NDA candidates and is open to remote candidates with a preference for East Coast locations.

Requirements

• BS/MS and >8+ years of industry experience or PhD/PharmD with >3 years of industry experience
• Strong knowledge of drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamic and bioanalytical principles is required
• Excellent written and verbal communication skills
• Demonstrated presentation skills
• Excellent interpersonal skills and ability to represent DMPK in a team environment are essential
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, oversee, and guide the work of external colleagues (consultants and CROs) to achieve meaningful outcomes and create business impact

Responsibilities

• Design and execute preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of drug candidates
• Represent DMPK and bioanalysis as the subject matter expert at project teams
• Responsible for the analysis, interpretation, integration and reporting of preclinical DMPK data generated with external vendors/academic sites
• Directs the planning of all relevant nonclinical (DMPK), bioanalysis and PK/PD analyses. Utilizes consultants, CROs to accomplish work
• Coordinates with medical writers (and other team members) in the data review, analysis, and reporting of the nonclinical DMPK studies
• Author high quality Regulatory documents including INDs, CTAs and NDA filings. Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management and other departments
• Participate in the preparation of abstracts and manuscripts for publication
• Accountable for ensuring that there are valid methods for measuring drug concentration (and any biochemical biomarkers) in the clinic
• May participate in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management

Preferred Qualifications

• Experience using WinNonlin or other pharmacokinetic software is a plus
• Experience with PK/PD
• Experience with LC/MS/MS method development is desirable

Benefits

#LI-Remote