Director, Fluid Biomarkers

At Biogen, we offer a workplace that is unique, connected, resilient and impactful. Our purpose to find cures for rare diseases is a unique focus within our industry. We are connected as a team by this shared purpose, the pride we have in our work, and the inspiration we obtain from the lives we’re changing. We are resilient as we overcome obstacles, following the science to deliver for our patients. Most of all, our work allows us to have an impact. An impact on our patients’ lives and on changing the course of medicine.

As the Director, Fluid Biomarkers, you will oversee and support the development, implementation, and execution of biomarker strategies in support of programs across the Neuromuscular or Immunology portfolio.

What You’ll Do:

• In collaboration with other members of the fluid 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 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 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; Author and/or provide senior review of clinical protocols, medical affairs and regulatory documents/filings
• 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

Required skills:

• PhD with 10+ years relevant experience and 5+ years’ experience directly leading/implementing clinical biomarker strategies.
• Deep expertise in executing clinical biomarker strategies across a range of modalities (i.e. small molecule, biologics, anti-sense, gene therapy), with an emphasis on pivotal and/or LCM 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
• Well versed in relevant technologies, particularly immunoassay technologies (e.g. ELISA, Gyros, Quanterix, Ella) with strong understanding of inherent advantages and limitations specifically with respect to clinical implementation
• 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
• Proven scientific leadership and matrix management of high performing individuals and cross functional teams required
• Ability to prioritize and deploy resources effectively and appropriately to meet key goals and timelines

The Fluid Biomarker group, within the Clinical Sciences Division, is seeking a highly motivated, experienced individual to join a dynamic team engaged in the implementation of biomarkers to support clinical therapeutic development.

All your information will be kept confidential according to EEO guidelines.