Mapp Biopharmaceutical
  • San Diego, CA, USA
  • Full Time

 

Director, Bioanalytical Sciences and Preclinical/Nonclinical Development

Job #18-20A

 

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 Bioanalytical Sciences to support nonclinical and clinical development efforts. The Director of Bioanalytical Sciences will provide overall support for our projects including design, execution, supervision, analysis, interpretation and communication of fit-for-purpose nonclinical and clinical pharmacokinetic and safety studies.  The Director will primarily be responsible for oversight of bioanalytical and immunogenicity assay design and execution.  Additionally, the Director will serve as a nonclinical representative on project teams and will be a point person for execution of nonclinical studies supporting advanced development of candidate therapeutics. This role will include interaction with broader clinical, CMC and regulatory teams as necessary.

Basic Qualifications:

  • PhD in biology, molecular biology, biochemistry, Pharmacokinetics (PK), Drug metabolism, pharmacology, and/or a related field
  • 8+ years of experience in the development of biologics
  • 2+ years in bioanalytical assay development
  • Prior experience working with antibody-based therapeutics in infectious disease indications
  • Possess a deep understanding of biologics PK, PD, and immunogenicity principles and the relevant bioanalytical methods and tools
  • 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
  • Highly motivated with exceptional interpersonal, written and oral communication skills
  • Prior experience with INDs and/or BLAs
  • Knowledge of PK and drug metabolism principles and regulatory guidance
  • Demonstrated experience managing complex matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization
  • Excellent written and verbal communications skills with strong ability to present scientific/technical information to diverse audiences

Preferred Qualifications:

  • Prior experience working with high-pathology BSL-3/BSL-4 agents is advantageous
  • Infectious disease and Animal Rule experience
  • Experience delivering programs applying the FDA's Animal Rule guidance
  • Broad understanding and direct experience in leading a mAb/protein therapeutic through the Drug Development paradigm from pre-Candidate Selection through Post-Licensure to support a team through generation and execution of Regulatory strategies

Responsibilities

  • Leads the development, qualification, validation, and execution of large molecule ligand-binding based bioanalytical assays to support the development of monoclonal antibody-based therapeutics
  • Directs all efforts related to the bioanalysis, reporting and interpretation of data from nonclinical and clinical studies, as well as the bioanalytical flow from discovery to validation including technology transfer and oversight of the Sponsor-CRO relationship
  • Supports preclinical PK and clinical PK aspects of mAb development programs and has significant design impact into non-GLP and GLP animal studies
  • Participates in review of key development study protocols, reports and/or white papers
  • 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 consults on all clinical PK studies
  • Oversees outsourced PK sample testing and data analysis 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, or may have the opportunity to work remotely. Travel (~25%) will be required for this position. Mapp wants you to join their team and invites you to apply.

No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.

Mapp is an 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.

Mapp Biopharmaceutical
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