We area seeking an Associate Director/Director to join the Bioanalytical Sciences group in the Translational and Development Sciences department, to support our Biosimilar and Immuno-Oncology programs. The candidate will be overseeing development and validation of PK and immunogenicity assays, will represent the group in cross-functional Product Development Teams, and will be responsible for the bioanalytical portion of clinical study reports and of regulatory submissions (e.g. BLAs).
The candidate will have strong tactical and hands-on experience in pharmacokinetics and immunogenicity of protein therapeutics. Experience in assay development and validations of PK or immunogenicity assays to support preclinical and clinical studies is a must, and experience overseeing bioanalytical CROs is desirable. Experience in the development of Companion Diagnostics is a plus.
Candidate should also have experience assessing and describing PK and immunogenicity data in the context of efficacy and safety clinical studies, and with regulatory submissions such as BLAs. Specific experience in the successful development of biological therapeutics in the field of biosimilars or immuno-oncology is not necessary but highly desirable. In addition, the successful candidate will have outstanding communication skills, and strong project management skills to ensure projects adhere to timelines, quality, efficiency, in alignment with the budget, and meet objectives.
Primary Responsibilities and Duties
Primary responsibilities include the design and execution of bioanalytical studies (PK, immunogenicity and biomarkers) to support preclinical and clinical studies. Good planning, budgeting, project management, and verbal and writing communication skills are a must.
Direct and oversee development and validation of PK and immunogenicity assays
Initiate and manage contracts, coordinate activities with select Contract Research Organizations (CROs) in the areas of pharmacokinetics, immunogenicity, and biomarkers
Manage the conduct of bioanalytical assays to support clinical studies, primarily at CROs
Contribute to Clinical Study Reports and regulatory documents and interactions to support INDs, BLAs, RFMs, IRs
Works closely with cross-functional areas, colleagues and consultants to ensure that bioanalytical studies are performed in a quality, timely and scientific manner
Provides strategic expertise to cross-functional project teams as the Bioanalytical Sciences team representative
Balance multiple priorities in a fast-paced, team-based environment and work independently when needed, building structure from ambiguity and helping teams to develop priorities
Ensures compliance with GMP, GLP, and regulatory guidelines
Requirements and Job Qualifications
Demonstrated experience in the design and management of bioanalytical studies for protein therapeutics
Experience with biologics drug development with focus on FDA and EMA regulations
Self-organizing, self-directing and highly motivated with strong critical thinking and analysis skills
Strong communicator, experienced with influencing and interacting at all levels including with senior scientific, operational or external thought leaders to drive connectivity and efficiency of collaborative research
Excellent presentation skills and Exceptional computer and software literacy in relevant areas - PPT, excel, GraphPad, Gantt Chart
Previous experience and success with choosing, negotiating, and managing relations with contractors, including CROs
Hands-on experience working in GLP or GLP-like environments
PhD or equivalent with 2+ years or M.Sc. with 5+ years pharmaceutical/biotechnology industry experience in bioanalytical work for protein therapeutics immunology, cell biology or
Proven record of scientific publications is a plus
Experience in development and validation of clinical assays that support PK, Immunogenicity and biomarker assessments for biologics
Experience managing a group or a project (in-house or outsourced to CROs)
Experience in successful development of Biosimilars, Immuno-Oncology biological therapeutics is a plus
Experience with all phases of pre-IND through Phase I/II/III biological therapeutic development programs, and associated regulatory filings is a plus
Experience in the development of Companion Diagnostics is a plus