Your Role:New Biological Entities Drug Metabolism and Pharmacokinetics (NBE DMPK) Lead is a strategic, scientific and operational role in Research and Development (R&D). Our company is committed to bringing transformational medicines to patients, and you will collaborate in a matrixed environment with other passionate functional experts to deliver novel biotherapeutics. You will be responsible for managing the overall DMPK contributions to specific NBE projects, including antibody oligonucleotide conjugates (AOCs) and other biologics, from molecule design through preclinical and clinical phases, thus fulfilling internal and regulatory requirements. You will define and refine the appropriate DMPK strategy for each molecule, including PK strategies to de-risk the clinical development plan, communicating bioanalytical strategies both preclinically and clinically, and immunogenicity risk assessments (IRAs), and for ensuring that studies are conducted on time and with the required quality. You will also be responsible for ensuring there is an appropriate M&S approach during the early discovery phases for assigned molecules, which could include working with experts to support integration of all existing knowledge on the molecule(s) and target(s) to acquire meaningful and research question-oriented M&S insights. You should also be able to integrate the various bioanalytical and immunogenicity data to interpret drug disposition (pharmacokinetics and PK/PD) to guide engineering and optimization strategies of our biotherapeutics. In addition, an important requirement is having a broad experience in all aspects of bioanalytical sciences, particularly in PK and be able to provide technical oversight. You will be responsible for leading a small team of lab scientists, skilled in bioanalytical methods and relevant regulatory expectations. The NBE DMPK Lead is a member of discovery project teams and/or global programs, depending on the phase of the project, and a scientific matter expert on teams, ensuring proper flow of information between the project, the function, and key stakeholders. You will ensure that studies within the NBE DMPK responsibility of the given project are conducted according to the agreed timelines and the required quality, and you will be accountable for DMPK contributions to international health authority submissions.
Who You AreMinimum Qualifications:- Ph.D. in Biochemistry, Biology, Chemistry, or related field.
- Experience with biological molecules (NBEs, ADCs, other novel modalities), in particular AOCs.
- Expertise in PK, bioanalytics, immunogenicity, and/or relevant sciences in AOC discovery/development.
- 5-7+ of professional experience in drug discovery/development, with excellent knowledge of drug discovery and development processes and workflows.
- Previous leadership experience, managing a team
- Fluent spoken and written English
Preferred Qualifications:- Solid understanding of translational sciences, regulatory requirements and work packages for biotherapeutics (nonclinical and clinical).
- General knowledge of disease areas (e.g. Immunology, Oncology, etc.), and an in-depth understanding of biology and pharmacology.
- Experience in a global matrixed environment
Role will be on site in Billerica, MA
Pay Range for this position: $164,600- $246,800. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
