Principal Scientist, Translational Sciences

Biogen

Job Location:

Cambridge, MA - USA

Monthly Salary: $ 141000 - 188000

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

About This Role

The Biomarkers and Systems Biology group is seeking a highly motivated Principal Scientist to join a dynamic team responsible for developing and executing bioanalytical strategies across multiple therapeutic programs. This role is central to the development optimization and validation of bioanalytical assays supporting early and latestage clinical studies. The Principal Scientist will lead immunogenicity strategy provide scientific oversight of CROexecuted assays and contribute to global regulatory submissions.

The ideal candidate has deep expertise in pharmacokinetic and immunogenicity bioanalysis with additional experience in biomarker methods. Handson assay development experience across multiple platforms and a strong understanding of regulatory expectations with are essential. The role requires scientific rigor sound judgment and the ability to operate effectively in a fastpaced biotech environment.

What Youll Do

Lead development optimization and validation of PK biomarker ADA NAb and other immunogenicityrelated assays in alignment with FDA EMA and ICH guidelines.

Develop and execute immunogenicity strategy including risk assessments aligned with modality target biology and clinical stage.

Oversee outsourced biomarker immunogenicity and bioanalytical assays at CROs providing scientific direction troubleshooting protocol guidance and data review.

Analyze and interpret PK PD safety biomarker and immunogenicity data in close collaboration with Clinical Development Clinical Pharmacology Translational Medicine Safety and Regulatory Affairs.

Ensure data integrity traceability and scientific clarity across all bioanalytical and regulatory deliverables.

Evaluate implement and provide expertise across analytical platforms (e.g. ELISA MSD etc.).

Prepare regulatory responses briefing packages and support interactions with health authorities.

Serve as the Bioanalytical Lead on study and program teams defining strategy and ensuring alignment with development objectives.

Deliver scientific presentations internally and externally and contribute to manuscripts and publications.

Promote best practices in assay development CRO oversight and scientific rigor.

Who You Are

You are a scientifically rigorous bioanalytical expert who thrives on developing validating and troubleshooting complex PK immunogenicity and biomarker assays to support clinical programs.

You are motivated by driving highquality clinically relevant bioanalysis and immunogenicity strategy and you excel at interpreting data in a crossfunctional fastpaced environment.

You enjoy partnering with internal teams and CROs providing clear scientific direction and ensuring assays meet regulatory and program needs.

You communicate clearly work independently and bring strong judgment to problemsolving regulatory interactions and strategic decisionmaking.

This position is based in Cambridge MA and requires regular onsite presence; candidates must be within commuting distance or willing to relocate.

Required Skills

PhD (preferred) or MS in Immunology Cellular and Molecular Biology or a related scientific field.

PhD with 8 years of relevant industry experience

MS with 12 years

Handson expertise with ligandbinding assays (ELISA MSD Simoa) cellbased assays PK/PD biomarker methods and ADA/NAb assay development.

Advanced technical expertise in method development and validation in a regulated environment

Experience supporting clinical trial sample analysis and data review.

Strong understanding of global regulatory expectations (FDA EMA ICH MHRA) for bioanalytical and immunogenicity submissions.

Deep experience authoring Integrated Summary of Immunogenicity and other regulatory filing documents

Proven experience managing CROs and external scientific partnerships.

Excellent technical writing analytical interpretation and communication skills.

Ability to work independently and effectively influence crossfunctional teams in a matrixed environment.

Strong verbal and written communication skills with the ability to tailor presentations to diverse audiences.

Highly flexible resultsoriented and comfortable operating in a fastpaced dynamic environment.

Proficiency with ligandbinding and cellbased assay technologies across multiple platforms.

Industry experience in biotech/pharma in a senior bioanalytical role.

Job Level: Management

Additional Information

The base compensation range for this role is: $141000.00-$188000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.

Regular employees are eligible to receive both short term and long-term incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.

In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social well-being; including but not limited to:

Medical Dental Vision & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10000 per calendar year
Employee Resource Groups participation

Why Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.

Required Experience:

Staff IC

About This RoleThe Biomarkers and Systems Biology group is seeking a highly motivated Principal Scientist to join a dynamic team responsible for developing and executing bioanalytical strategies across multiple therapeutic programs. This role is central to the development optimization and validation...