Director, Bioanalytical Sciences

Title:                                     Director, Bioanalytical Sciences
Reports To:                         Vice President, Translational and Development Sciences
Location:                             Redwood City, California
Classification:                     Exempt

Overview:

Coherus BioSciences, Inc. is a seeking a Director to join the Bioanalytical Sciences group. 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 clinical studies is a must, and experience overseeing bioanalytical CROs is desirable. Experience with immunogenicity prediction, in vitro diagnostics to use as biomarkers, or CDx development 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. 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 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

Education/Experience:

• 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 in working with U.S. and European regulatory authorities
• Experience with all phases of pre-IND through Phase I/II/III programs and associated regulatory filings
• Experience in the development of Companion Diagnostics is a plus

Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.