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Senior Scientist/Associate Director, Immuno-Oncology Bioanalytical

Employer
Coherus BioSciences
Location
Redwood City, CA
Start date
May 22, 2024

View more

Discipline
Science/R&D, Bioengineering, Biotechnology, Oncology
Required Education
Masters Degree/MBA
Position Type
Full time

Job Details


Title: 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. **

Company

Coherus is focused on expanding patient access to important, cost-effective medicines and delivering significant savings to the U.S. healthcare system. Every member of the Coherus team is dedicated, motivated, and passionate about expanding patient access to lifesaving therapeutics. Our colleagues are experts in analytical and process sciences, deeply experienced in clinical development and regulatory affairs, and have proven commercial and marketing capabilities. Everyone at Coherus is committed to meeting the highest standards, inspiring our teammates, and achieving our goals.

Coherus was founded a decade ago to provide the highest quality biosimilar treatments to patients. We are proud to now be expanding our legacy—to build on our success with biosimilars and to focus our core strengths on immuno-oncology.

At Coherus, our employees are our most important asset. We have a dynamic and rewarding organizational culture that offers the opportunity to work with leading industry professionals who are dedicated to making a difference for patients. We are looking for individuals who see unlimited potential in themselves and are motivated by a continuous passion for breaking down barriers and expanding access to lifesaving therapeutics.

Coherus offers a competitive total rewards program comprised of various elements, including competitive base pay, short- and long-term incentives in the form of performance-based cash and equity, as well as health and wellness benefits that include

•    Healthcare: Coherus pays 90% of premiums for medical, dental, and vision coverage for our

     employees, their eligible spouses, dependents, and domestic partners.
•    Health Savings and Flexible Spending Accounts
•    Group Life, Disability, and Group Accident Insurance
•    401(k) with company match, and an Employee Stock Purchase Plan (ESPP)
•    Paid Time Off (PTO) 
•    Health & Wellness programs, including a Health Club Reimbursement and an Employee Assistance Program
 

Health & Wellness programs, including a Health Club Reimbursement and an Employee Assistance Program

In addition to providing attractive rewards packages, we encourage and support our employees to find the right balance of work and personal time. Coherus offers a variety of activities, perks, and holidays that encourage employees to have a healthy outlook, spend time outside of work with friends and family, and foster a productive and collaborative work environment. Our culture is one in which we challenge and support all our team members to do their best work.

For more information about Coherus, please check out: https://www.coherus.com/about-coherus/

Company info
Website
Phone
800-794-5434
Location
333 Twin Dolphin Dr, #600
Redwood City
CA
94065
United States

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