Spirovant is looking for a Director, Bioanalytical Development. The successful candidate will be responsible for leading, developing and executing on Spirovant’s bioanalytical strategy and overseeing the development, qualification and validation of PK/PD, biomarker and immunological assays in support of both preclinical and clinical studies.

Responsibilities:

·        Lead the development, qualification and validation of PK/PD, biomarker and immunological assays, sample analyses, data interpretation and communication of results. Provide leadership and oversight for CRO laboratory selection, protocol development, data integrity, and adherence to project timelines and budget.

·        Mentor others on guidelines, concepts and technical details of various bioanalytical methodologies.

·        Lead cross-functional teams and construct phase-appropriate, risk-based bioanalytical strategies for use across all gene therapy programs.

·        Regularly present strategies and priorities to senior management, and make project focused development recommendations.

·        Write and review appropriate sections of nonclinical, clinical and regulatory documents.

 

Requirements:

·        BS with 8+ year, MS with 6+ years, or PhD with 5+ years of relevant industry experience

·        Strong scientific background and experience with PK/PD, biomarker, clinical immunology and immunogenicity bioanalytical assay development and validation.

·        Experience with cell/gene therapy viral vector bioanalytics strongly preferred

·        Proven past accomplishments of leading the successful development, implementation, and validation of bioanalytical methods, internally and/or externally, ranging from "fit-for-purpose" through full GLP/GCP.

·        Understanding of FDA and global regulatory requirements as they pertain to nonclinical and clinical analytical methodologies

·        Strong external and internal partnering behaviors

·        Excellent written and oral communication skills

·        Proven ability to independently manage multiple projects/tasks at one time

·        Ability to travel to CRO partners, and Philadelphia main office, on an as-needs basis 

Spirovant is committed to fostering a diverse, inclusive environment and is proud to be an equal opportunity employer.