Biogen · 11 hours ago
Clinical Development Lead, Rare Autoimmune Nephrology Programs
Biogen is a mid-sized biotechnology company committed to transforming the lives of patients with severe immune-mediated diseases. The Clinical Development Lead for Rare Autoimmune Nephrology Programs will oversee clinical development plans and ensure the execution of impactful studies in collaboration with various teams, driving innovation in treatment options for patients.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
Lead or support clinical development plans across early- and late-stage programs in rare autoimmune and nephrology indications
Provide medical and scientific oversight for biopsy-based, biomarker-driven, and mechanistic studies
Partner with Translational Science and Biomarker teams to define scientific hypotheses and exploratory endpoints
Support early clinical development efforts, including dose selection and study design
Collaborate with Clinical Operations to ensure study feasibility and oversight of trial execution
Analyze and interpret translational and clinical data, integrating biomarker and clinical efficacy datasets
Draft and oversee completion of clinical study reports, manuscripts, and presentations
Contribute to regulatory strategy and interactions with global health authorities
Partner with Medical Affairs and Commercial teams for alignment of clinical insights with development strategies
Establish relationships with key opinion leaders and academic collaborators
Represent Biogen in scientific, regulatory, and industry forums
Ensure compliance with GCP and ethical standards across development activities
Support due diligence and business development initiatives with clinical expertise
Qualification
Required
MD or equivalent degree, with board certification in nephrology, immunology, rheumatology, or a related field
3+ years of clinical development experience in the pharmaceutical or biotechnology industry
Experience in biopsy-based or translational studies and biomarker data interpretation
Strong understanding of clinical trial design, including adaptive and biomarker-enriched approaches
Experience with early-phase (Phase 1–2a) trials, including first-in-human studies
Knowledge of regulatory requirements and participation in global health authority interactions
Ability to interpret complex biological and clinical data into development strategies
Exceptional communication and leadership skills for matrixed organizational influence
Strategic and creative mindset suitable for a fast-paced environment
Willingness to travel (10–20%) domestically and internationally
Preferred
Experience with mechanistic studies in early-phase trials
Proven track record of establishing relationships with key opinion leaders
Familiarity with startup-like environments
Benefits
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
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Recent News
Pharmaceutical Technology
2026-01-05
thecanadianpressnews.ca
2025-12-24
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