(Senior) Director, Large Molecule DMPK
Proclinical is seeking a (Senior) Director, DMPK and Large Molecule Bioanalytical to join an innovative pharmaceutical company located in San Francisco, CA.
In this role, you will design, supervise and interpret experiments to study the ADME properties of large molecule therapeutics. This role requires candidates to be onsite daily.
Must be eligible to work in the US.
Essential Duties and Job Responsibilities:
- Serve on project teams at various stages of discovery and development as a subject matter expert for DMPK Biologics, providing PK or PK/PD expertise to the design of nonclinical PK, toxicology, or pharmacology studies.
- Prepare study protocols and coordinate execution of nonclinical studies which may involve multiple functional areas and CROs.
- Design and perform complex PK-PD analysis to answer translational questions in support of project deliverables and first-in-human dose predictions.
- Interpretation and strategy for evaluating the impact of anti-drug antibody (ADA).
- Participate in business development and licensing evaluations.
- Work closely with project teams, line management and CROs to assure high quality and timely delivery of written PK reports and regulatory documents (IND, IMPD, IB, BLA) for regulatory submissions.
- Supervising of research scientists and associate scientists may be required.
Knowledge, Experience and Skills:
- Requires a highly motivated individual with a PhD and 14+ years of post-graduate industry experience in the fields of pharmacokinetics, drug metabolism, pharmaceutics, or related life science field primarily supporting the PK characterization of large molecule/biologics through discovery and development.
- Applicant must demonstrate excellent verbal and technical communication, independent scientific thinking, with the ability to interpret results, determine next steps and present data to project teams and senior management.
- Applicant must demonstrate intellectual curiosity and propensity to stay current with latest advances in DMPK of biologics and PK analysis with a proven track record of sustained external visibility through publications, presentations and/or involvement in professional organizations.
- Applicants must be highly experienced in the application of PK-PD and multi-compartmental modeling software systems such as Phoenix/WinNonlin, MATLAB/Simbiology, or similar.
- Knowledge in the application of large molecule/biologics ligand binding assays and LC/MS bioanalysis is highly desirable.
If you are having difficulty in applying or if you have any questions, please contact Danielle Bahnasy at (+1) 646-868-5142 or d.bahnasy@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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