Lead DMPK and Bioanalysis Consultant

Seeking a motivated individual with accountability for overseeing all aspects of DMPK relating to the development of large molecule drug candidates, including the design, conduct, and reporting of nonclinical DMPK studies as well as bioanalysis of nonclinical and clinical studies data. Reporting directly to the senior director, head of clinical pharmacology, you will have the opportunity to collaborate with a highly skilled team and make a significant impact on our scientific endeavors. This is an exciting opportunity to be the DMPK and bioanalytical lead for a potential NDA. 

Key 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. 

Desired Experience/Education and Personal Attributes: 

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