Director, Preclinical/Nonclinical Development
Mapp Biopharmaceutical, Inc. "Mapp" develops novel pharmaceuticals for the prevention and treatment of infectious diseases, focusing on unmet needs in global health and biodefense. Mapp is currently looking for a Director of Preclinical/Nonclinical Development to work with our Early Research and Advanced Research and Development Teams. The Director of Preclinical/Nonclinical Development will provide overall preclinical and nonclinical support for our projects including design, execution, supervision, analysis, interpretation and communication of fit-for-purpose nonclinical and clinical pharmacokinetic and safety studies.
- PhD in Pharmacokinetics (PK), Drug metabolism, Toxicology, animal efficacy/Pharmacodynamics (PD) and/or a related field required
- 10+ years of experience in the development of biologics required
- Prior experience working with antibody-based therapeutics in infectious disease indications
- Possess an understanding of biologics PK, PD, immunogenicity, and toxicology
- Prior experience in a biopharmaceutical environment (with a sponsor or a contract research organization)
- Experience in mechanism of action determination
- Experience in working with government funding and regulatory agencies
- Experience in managing projects, timelines, budgets, risks, and reporting deliverables
- Deeply grounded in the scientific principles of PK, PD, immunogenicity and relevant bioanalytical methods and tools
- Highly motivated with exceptional interpersonal, written and oral communication skills
- Experience delivering programs applying the FDA's Animal Rule guidance
- Prior experience with INDs and/or BLA experience
- Infectious disease and Animal Rule experience
- Knowledge of PK and drug metabolism principles and regulatory guidance would be beneficial
- Prior experience working with high-pathology BSL-3/BSL-4 agents is advantageous
- Supports preclinical PK and clinical PK aspects of mAb development programs and has significant design impact into non-GLP and GLP animal studies
- Provides direct preclinical/nonclinical support to all product development programs in the Mapp portfolio
- Works hands-on with teams at various stages of R&D from Discovery through to Licensure.
- Maintains effective CRO relationships that support the execution of nonclinical and clinical PK and PD studies and will have Project Management (PM) requirements
- Works with a multidisciplinary team of Scientists and Drug Developers
- Supports Mapp's vision for translational PK/PD and effectively communicates it throughout all of the Mapp organization
- Oversees the execution of all preclinical and clinical PK studies
- Oversees outsourced PK data if required and provides detailed analysis and PK/PD modeling and simulation
- Creates custom study designs and protocols and implements them to evaluate Mapp's products
- Interfaces with ADME and PK experts to characterize the full PK-PD and toxicodynamic profiles of the novel drugs
- Contributes to preclinical/nonclinical laboratory work and troubleshooting as needed, which may include isolated tissue, cell-based, colorimetric, HPLC and ELISA assays
- Supports the filing of applications for human studies by preparing reports and appropriate sections of regulatory documents and represents the company at EMA/FDA meetings
- Partners with PM team to provide preclinical/nonclinical PM deliverable inputs (task progression, budget progression, risks, reporting)
- Provides oversight for and guidance to other preclinical/nonclinical team members
- Supports Development sub-teams with the following accountabilities:
- Leads the overall nonclinical/clinical assay, product development and validation plans in partnership with QA
- Supports the assay development from investigation through validation and transfer in line with budget and timeline
- Supports the documentation, execution, analysis and interpretation for a wide range of studies, including feasibility, exploratory, assay development and analytical validation
- Partners with R&D Operations/PM to manage outsourced work budgets
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego, CA, Washinton, DC, or may have the opportunitiy to work remotely. Mapp wants you to join their team and invites you to apply.
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Equal Opportunity/Affirmative Action/Disability/Vets Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.