Medical Director, Clinical Development, Rare Autoimmune Nephrology @Biogen

[Hiring] Medical Director, Clinical Development, Rare Autoimmune Nephrology @Biogen

Mar 18, 2025 - Biogen is hiring a remote Medical Director, Clinical Development, Rare Autoimmune Nephrology. 💸 Salary: $187,000 - $312,000. 📍Location: USA.

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Role Description

We are seeking a highly motivated and experienced Medical Director (MD) to support development activities for our portfolio of immunology clinical programs, with a specific emphasis on severe immune-mediated diseases related to glomerular kidney disease. Reporting directly to the Clinical Development Lead, the MD is a key member of the clinical development team, supporting the development of our novel therapeutic candidates in late-stage studies. The successful candidate will primarily be involved in activities associated with the design, execution, monitoring, data interpretation, and reporting of clinical studies evaluating novel therapies across target indications.

Support the design and execution of clinical development plans for HI-Bio's programs within rare autoimmune and nephrology therapeutic areas, ensuring alignment with strategic objectives and timelines
Provide medical and scientific oversight for clinical trials, including protocol development, study monitoring, data review, and analysis
Collaborate with Clinical Operations in trial setup, conduct, recruitment activities, closeout, and reporting
Draft and coordinate completion of clinical study reports
Prepare responses to questions from Ethics Committees and Health Authorities
Support integrated document development for marketing authorization filing
Interpret, report, and prepare oral and written results of product research, in collaboration with senior clinical personnel, in preparation for health authority submissions
Support preparation for FDA Advisory Committee and EU Oral Explanation
Provide leadership to cross-functional project teams with peers from clinical operations, biometrics, clinical pharmacology, biomarker sciences, regulatory affairs, and medical writing, and others
Establish and maintain relationships with key opinion leaders and clinical investigators in the nephroimmunology field and disease areas related to clinical development programs
Ensure compliance with regulatory requirements and guidelines
Collaborate with cross-functional teams
Participate in due diligence activities and provide medical expertise in support of business development initiatives as needed
Represent externally at scientific conferences, investor meetings, and other industry events

Qualifications

MD or equivalent degree, with board certification in nephrology, immunology, or similar field
Minimum of 3+ years of clinical development experience in the pharmaceutical or biotechnology industry, with a track record of successful drug development
Experience in late-stage drug development, with a preference for experience in nephrology and/or immuno-inflammatory indications
Strong knowledge of clinical trial design and execution, including experience with adaptive trial designs and biomarker-based approaches
Deep understanding of regulatory requirements for drug development, including experience leading interactions with global regulatory agencies
Excellent communication skills, with the ability to effectively communicate complex medical and scientific information to diverse audiences
Strong interpersonal skills, with the ability to establish and maintain relationships with key opinion leaders, clinical investigators, and internal stakeholders through a highly collaborative approach
Ability to travel domestically and internationally, approximately 10-20% of the time

Requirements

The base compensation range for this role is $187,000 - $312,000
Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job
This role is eligible for participation in Biogen’s LTI grants and other incentive programs
Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions

Benefits

Comprehensive health insurance
401(k) with company match

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📍	Be aware of the location restriction for this remote position: USA
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Medical Director, Clinical Development, Rare Autoimmune Nephrology @Biogen

All others

Salary 💸 $187,000 - $312,000	Remote Location USA
Job Type full-time	Posted Mar 18, 2025

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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[Hiring] Medical Director, Clinical Development, Rare Autoimmune Nephrology @Biogen

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