Senior Medical Director, Clinical Development - Rare Autoimmune / Nephrology

Job Description

HI-Bio, Inc., a Biogen company, is seeking a highly motivated and experienced Senior Medical Director and Clinical Lead to lead development activities for severe immune-mediated diseases in nephrology. As a key member of the leadership team, you will be responsible for driving the development of our novel therapeutic candidates from preclinical development through to clinical proof of concept and confirmatory studies. Reporting directly to the Head of Clinical Development, the Senior MD will be responsible for the following:

Responsibilities:

• Design and execute clinical development plans for HI-Bio's rare autoimmune programs, ensuring alignment with strategic objectives and timelines
• Provide medical and scientific oversight for clinical trials, including protocol development, study monitoring, data review, and analysis
• Build and lead a high-performing clinical development team of Clinical Scientists and Medical Directors
• Lead and develop cross-functional project teams to be collaborative and effective, empowering fruitful contributions from clinical operations, biometrics, clinical pharmacology, biomarker sciences, regulatory affairs, and medical writing
• Establish and maintain relationships with key opinion leaders and clinical investigators in the immunology field and disease areas related to clinical development programs
• Ensure compliance with regulatory requirements and guidelines, while providing leadership for interactions with regulatory agencies
• Collaborate with cross-functional teams, including research, preclinical development, manufacturing, medical affairs, and commercial, to ensure alignment of clinical development plans with overall product development strategy
• Participate in due diligence activities and provide medical expertise in support of business development initiatives
• Represent HI-Bio externally at scientific conferences, investor meetings, and other industry events

Qualifications

• MD or equivalent degree, with significant clinical experience in nephrology and/or immuno-inflammatory indications. 
• 5+ years of clinical development experience in the pharmaceutical or biotechnology industry, with a track record of successful drug development. Preference for late-stage drug development. 
• Demonstrated leadership experience, with the ability to build and lead cross-functional teams in a fast-paced, dynamic environment
• 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 think strategically and creatively, with a focus on delivering results and driving innovation.

Additional Information

HI-Bio, Inc. is a Biogen company based in South San Francisco, California. As of July 2, 2024, we are part of Biogen’s global team, with a commitment to excellence and a pioneering spirit. As part of a mid-sized biotechnology company, we offer 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.

Our team in 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.

The base compensation range for this role is $192,000 - $288,000. 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 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.

Why Biogen?

We are a global team with a commitment to e