About This Role
The Fluid Biomarker group is seeking a highly motivated, experienced individual to join a dynamic team engaged in the implementation of biomarkers to support clinical therapeutic development. This role is required to oversee and support the development, implementation, and execution of biomarker strategies in support of programs across the Neurodegeneration and Neuromuscular portfolio. The successful candidate will have a proven track record of strong leadership developing and delivering on biomarker strategies across all stages of drug development, including late-stage clinical development. Excellent strategic thinking, communication and collaboration skills are essential.
What You'll Do
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- In collaboration with other members of the biomarker team, develop and implement biomarker strategies for programs in clinical development, with an emphasis on pivotal/Phase 3 and marketed programs. Provide guidance and direction to fluid members of the group focused on biomarker strategy development and implementation.
- Liaise with relevant stakeholders in clinical, regulatory, and commercial to coordinate and align biomarker activities in support of clinical development and marketed programs in the Neuromuscular and Neurodegeneration franchise
- Build strong partnerships with external collaborators by identifying potential academic partners to accelerate achievement of biomarker goals and maintaining existing SRAs
- Matrix manage assay development scientists and oversee/manage multiple outsourced projects with contract research laboratories, technology partners, and academics
- Support the planning and execution of clinical trials and regulatory filings; Author and/or provide senior review of clinical protocols, medical affairs and regulatory documents/filings and regulatory engagements
- Actively engage with regulators and industry professionals via conference presentations, workshops, focus groups and publications to influence best practices for biomarker development and clinical implementation
Who You Are
You love clinical development in a fast-paced dynamic environment and are passionate about biomarkers. You are a highly flexible, results oriented, strategically-minded, independent self-starter who enjoys working through cross-functional collaboration and communicates clearly to drive key-business decisions and deliver novel therapies to patients.
Required Skills
- PhD preferred in related science field with 8+ years of experience in industry or Master's degree with 10+ years of experience or Bachelor's degree with 12+ years of experience
- Proven scientific leadership and matrix management of high performing individuals and cross functional teams required
- Deep expertise in executing clinical biomarker strategies across a range of modalities (i.e. small molecule, biologics, anti-sense), with an emphasis on pivotal and/or post-marketing studies
- Exceptional verbal and written communication skills; proven ability able to deliver clear, concise biomarker focused data and presentations tailored to different audiences including commercial colleagues
- Demonstrated leadership in biomarker sciences including authoring manuscripts, regulatory documents and direct interactions with regulators
- Strong understanding of the clinical development and life cycle management process
- Ability to quickly absorb new information and develop an understanding of the relevant biology, pathway, MOA, disease indication(s)
- Demonstrated ability to influence without authority and efficiently drive alignment amongst multiple stakeholders to efficiently progress programs/projects
- Well versed in relevant technologies, particularly immunoassay technologies (e.g. ELISA, Gyros, Quanterix, Lumipulse) with strong understanding of inherent advantages and limitations specifically with respect to clinical implementation
- Ability to prioritize and deploy resources effectively and appropriately to meet key goals and timelines
Job Level: Management
Additional Information
The base compensation range for this role is: $172,000.00-$237,000.00
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 $10,000 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 on to 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.