Medical Director, Clinical Development, Rare Autoimmune Nephrology

Company Description

Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.

Job Description

We are seeking a highly motivated and experienced Medical Director (MD) to support development activities for our portfolio our 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. Additional responsibilities involve managing external collaborations, gaining comprehensive knowledge of the literature related to the product(s) in development, supporting Regulatory interactions, and supporting Medical Affairs and Commercial colleagues.

As part of a startup environment, the role involves extensive matrix interactions with colleagues from various disciplines to ensure the successful execution of clinical development plans and regulatory filings.

What You Will Do

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

Who You Are

You have significant experience in clinical trials and can strongly communicate and present relevant clinical data to leadership and core teams. You are curious, creative and collaborative with a passion for improving the lives of patients with Rare Autoimmune Nephrology.

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.

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. Additionally, this role is eligible