Director/Sr. Director, Bioanalytical DMPK

Director/Sr. Director, Bioanalytical DMPK

We are seeking a Director-level individual to lead a group of motivated scientists in the Bioanalytical Drug Metabolism & Pharmacokinetics (BA-DMPK) Department.  Reporting to the Vice President of Nonclinical Development, this key individual will provide oversight for all BA-DMPK aspects of the development portfolio, as well as providing support to the Discovery Research and Clinical Departments.  A strong background in LC-MS and other platform-driven methods allowing for both bioanalysis as well as structural elucidation of both small molecules as well as monoclonal antibodies (mAbs) is essential, as is expertise in pharmacokinetic analyses.  As a subject matter expert, she/he will contribute to critical decisions impacting advancement of both drug discovery and development projects, and so excellent communication skills are required. Prior experience with preparation and review of regulatory filing documents to support IND, IB, CTA and NDA/BLA filings is essential. Broad experience with mAbs, small molecules, and peptides is preferred. 

Good things are happening at Omeros!

Come and be a part of our Nonclinical Team!

Who is Omeros?

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases) and cancers. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial. For more information about Omeros and its programs, visit  www.omeros.com.

Essential Duties & Responsibilities: 

• Build and lead a group of motivated scientists supporting drug development programs from Discovery Research through formal development to registration and life cycle management
• Ability to manage core BA-DMPK activities and to translate data from multiple sources into a comprehensive risk assessment to aid drug program progression
• Serve as a BA-DMPK representative on project teams supporting the discovery and development of novel mAb and small molecule therapeutics areas across various therapeutic indications
• Provide guidance in developing and implementing bioanalytical assays (e.g., LC-MS, ELISA and MSD) for the characterization of drug candidates and biomarkers in biological matrices in-house
• Lead the design, analysis and interpretation of in vitro and in vivo DMPK assays and studies with drug candidates to identify and risk-mitigate ADME challenges in the context of project progression
• Recommend, initiate, and champion ADME innovations that ensure cutting-edge science is applied to project questions
• Serve as primary author of nonclinical pharmacokinetics sections of US and international regulatory dossiers (e.g., IND, IB, BLA)
• Train, supervise, and mentor scientific staff
• Manage collaborations with CROs for outsourcing activities and ensure high quality study execution to meet program timelines

Education, Experience, Skills, and Knowledge Required:

• Ph.D. in DMPK or related field with 5-10 years of relevant experience in the pharmaceutical, biotechnology industry or contract research organization
• A comprehensive understanding of ADME principles with broad technical knowledge of bioanalysis and mechanistic biotransformation, as well as expertise in PK/PD analysis
• Strong knowledge of the regulatory requirements needed for DMPK support for new drug submissions and experience in compiling and writing regulatory documents

• Familiarity with the selection, characterization, and qualification of mAbs, small molecules, and biospecific therapeutics

• Aptitude with Microsoft Office applications is essential
• Strong bioanalytical method development skills on multiple technology platforms such as ELISA, MSD, and LC-MS
• High level of scientific integrity and understanding of current best practices for BA-DMPK analysis using current regulatory guidance documents
• Experience in representing BA-DMPK on project teams

Behavioral Competencies Required: 

• Ability to influence, negotiate and communicate with both internal and external stake holders
• Ability to work well in a collaborative, fast-paced, project team environment

If you have the experience, skills, and knowledge we are seeking, we’d love to hear from you! This is an exciting opportunity for the right person!

Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.

It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to  hr@omeros.com  or contact Omeros, asking for Human Resources, at (206) 676-5000.