United States onlyTitle: Senior Scientist/Associate Director, Immuno-Oncology Bioanalytical
Reports To: Director, Translational Medicine
Location: Redwood City, CA
Classification: Exempt
Overview:
Coherus is seeking an experienced and exceptional Senior Scientist/Associate Director, Immuno-Oncology Bioanalytical to support Immuno-Oncology clinical development projects focused on PK, immunogenicity (ADA) and biomarker assays. 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 and tumor and immune biomarker development is a plus.
The scientist will provide expertise to discovery and development project teams to ensure robust assay in clinical trials, and the validation status and any technical or statistical issues related to the proposed assays. This will include input on clinical protocols and associated documents and regulatory submissions. In addition, the scientist will direct the development, outsourcing and validation of clinically applicable assays (including PK, ADA and biomarkers) and design, implement and oversee testing and data analysis together with the functional area representatives. The successful candidate will work collaboratively in cross functional teams and within Translational Medicine Department to achieve these aims.
Coherus is a cross collaborative environment and the ability to work effectively across these groups is a key attribute for this role. Experience in evaluating and executing bioanalytical assays in clinical stage programs in immuno-Oncology field and an understanding of clinical development and immunology are highly desired.
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.
- 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 and regulatory documents and interactions to support development
- 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 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 in the US
- 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 team members to drive connectivity and efficiency of collaborative research
- Excellent presentation skills and computer and software literacy in relevant areas – Word, PPT, excel, GraphPad
- 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 or cancer
- 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. regulatory authorities
- Experience with in early phase clinical studies and associated regulatory filings
- Experience in immune and/or tumor based biomarkers a plus
The Base Salary Range for this position is $140,000 - $200,00 Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.
Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.
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.
** We are currently not accepting any unsolicited resumes from recruiters or employment agencies. **
