Senior Director, Pharmacokinetics, Dynamics, Metabolism and Bioanalysis, Protein Therapeutics

Senior Director, PK/PD and Bioanalytical Activities

At our Company, we are inspired by the belief that a research-driven enterprise dedicated to scientific excellence can create medicines that save and improve lives. Every employee is building on our proud legacy of scientific breakthrough. Our ability to impact the lives of patients worldwide depends on the integrity, creativity, humility and scientific acumen of our team. We are creating an organization that is inspired by invention and founded on a culture of respect and collaboration.

At our Company's Research Labs Boston, you'll have the opportunity to expand your knowledge and skills through collaboration with talented and dedicated colleagues while advancing your career.

The Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) group is seeking a dynamic, strategic thinking and collaborative Senior Director to contribute to our Company's protein therapeutic efforts from discovery through to candidate selection and into FIH trials. This position will be based at our research labs in Boston, MA. This senior leader will provide scientific and operational oversight for PK/PD and bioanalytical activities related to protein therapeutic drug candidates, including bispecific antibodies, antibody-drug conjugates (ADCs), fusion proteins, and emerging modalities.

The successful candidate will lead a group of principal investigators and subject matter experts and will be expected to collaborate cross-functionally with discovery biologics, nonclinical drug safety, translational medicine and therapeutic area colleagues to ensure robust program strategies from early discovery through to IND submission and beyond. Modality and therapeutic area support will focus on protein therapeutics in our immunology and oncology portfolios, with the potential to contribute other modalities across multiple therapeutic areas.

In this exciting position, your primary roles will include:

• Oversee the design and interpretation of pharmacokinetic, immunogenicity and ADME studies for protein therapeutics across multiple disease indications and therapeutic areas
• Mentor and manage a team of high performing PDMB scientists and managers (multi-tiered organization) supporting protein therapeutic optimization (PK, distribution, translational strategy) and discovery bioanalytics (ligand binding assays, mass spectrometry)
• Design, implementation and analysis of in vitro and in vivo studies to understand the impact of drug disposition on disease biology, pharmacological response (PK/PD) and safety
• Contribute to global PDMB strategy through close collaboration with project teams in Boston (MA), South San Francisco (CA) and West Point (PA) focusing on building highly efficient strategies to identify and optimize protein therapeutic drug candidates

Education Minimum Requirement

• Ph.D (with 7+ years relevant experience) degree in biochemistry, pharmacology, pharmaceutical sciences, protein engineering, molecular biology, bioengineering, or related STEM field;
  Relevant experience that includes a record of increasing responsibility and independence in a similar industrial/academic setting

Required Experience and Skills

• Demonstrated experience leading protein therapeutic discovery efforts as a group leader or independent project-team representative within a highly collaborative environment
• Strong understanding of protein therapeutic bioanalytical, ADME, FcRn biology, target-mediated drug disposition (TMDD) and immunogenicity concepts for modalities such as monoclonal antibodies or engineered bispecifics
• Proven track record of managing scientists and leading cross-functional teams in a drug discovery or development setting
• Experience contributing to development and execution of translational PK/PD efficacy relationships, human dose predictions and other useful quantitative pharmacology applications in a discovery setting
• Strong leadership, interpersonal, communication, problem solving and collaborative qualities to deliver high quality results in a fast-paced environment

Preferred Experience and Skills

• Hands-on experience performing or interpreting data from translational PK/PD/efficacy or physiologically-based pharmacokinetic (PBPK) models (e.g., Phoenix Win Nonlin, Berkeley Madonna, MATLAB).
• Proven track record supporting immunology or oncology-based programs with experience spanning from early discovery through IND-enabling effort
• Expertise with designing and troubleshooting ligand binding assays or hybrid-LC/MS assays for the detection and quantitation of protein therapeutics in various matrices (non-GLP)
• Experience working within a research-driven pharmaceutical company

Required Skills:

ADME, Assay Development, Bioanalysis, Bioanalytical Assays, Bispecific Antibodies, Communication, Cross-Cultural Awareness, Drug Discovery Development, Drug Metabolism, Fast-Paced Environments, Immunology, Immunotherapy, Innovation, Ligand Binding Assay, Modeling Simulations, Monoclonal Antibodies, Oncology, People Leadership,…