Director - Bioanalytic, Pharmacology and Biomarker Development
Wave Life Sciences USA seeks experienced and highly motivated individual to join its team in Lexington/Cambridge, Massachusetts. The incumbent will develop and implement bioanalytical and biomarker strategies for multiple early and mid-stage assets that include nucleic acid based (stereo pure ASO) assets. The major focus of the role will be to lead development, qualification, validation of variety of methods to support neurology and neurodegeneration therapeutic areas within the development pipeline at Wave Life Sciences. This is an ideal position for an individual with a strong background in analytical chemistry and/or nucleic acid chemistry, biochemistry or related field who thrives in a team-oriented, fast-paced, and cross disciplinary biotech environment. The candidate will be an integral member of a team of scientists aiming to rapidly and pragmatically realize the potential of an emerging technology.
- Supervise and mentor a group of scientists, employ cutting edge and traditional LC-MS/MS, immunoassays and molecular technologies to develop assays, qualify or transfer methods to CRO partners to validate and support preclinical and clinical studies as appropriate.
- Responsible for managing the Biomarker/ BA Team within BPBD, overseeing the development & implementation of immunoassays, molecular and other technology based biomarker assays in support of multiple therapeutic area programs. Employ innovative technologies as necessary to bring novel solutions to accelerate clinical development, support the development of patient stratification assays or companion diagnostics.
- Work with CRO laboratories to develop/transfer, validate, and support assay implementation. Work with BPBD colleagues and legal/compliance dept. to ensure the analytical work is performed according appropriate regulatory and GLP/GCLP guidelines.
- Serve as strategic and scientific representative at core project teams, sub-teams. Provide input into or create bioanalytical and biomarker strategies as applicable for the development stage. Maintain knowledge of a specific therapeutic area, interface with internal stake holders such as other scientists, project team reps, DMPK, preclinical & clinical pharmacology, and Preclinical development/Toxicology, clinical operations. May also interface with external KOLs as relevant based on the project scope and goals
- Author and review technical reports, documents related to bioanalytical work, appropriate sections of clinical protocols, global regulatory filing documents, scientific abstracts, publications and presentations.
- Familiar with regulatory expectations (FDA and EMA) and industry’s best practices in bio analytical assay development and validation of biomarker/diagnostic assays
- Strong understanding of drug discovery & development, spanning all stages of preclinical and clinical development, drug approval process and life cycle management.
- Experience in Bioanalytical practices, GLP and GCLP guidelines/practices, working with cross-functional teams, project representation experience, and management experience required.
- Ability to quickly absorb new information and develop an understanding of the relevant biology, pathway, MOA, disease indication(s) and manage multiple projects simultaneously.
- Proven scientific and strategic leadership of cross-functional teams, matrix managing people and complex projects and communication abilities (written and verbal) is a must.
- Demonstrated ability to influence without authority and efficiently drive alignment amongst multiple stakeholders to efficiently progress programs/projects.
- Ability to prioritize and deploy resources effectively and appropriately to meet key goals and timelines
- Demonstrated ability in applying innovative approaches to problem solving is a plus.
- Project representation/leadership experience is preferred.
- Ph.D. in Immunology, neurobiology, cell/molecular biology or a related field is required.
- 10-15 years of experience in the development, application of bioanalytical & biomarker assays (LC-MS, immunoassay platforms and molecular assays) in preclinical and clinical drug development required.