Senior Medical Director, Clinical Development

Accountabilities

The Senior Medical Director, Clinical Development will provide medical and scientific leadership throughout clinical development programs, supporting strategy creation, trial execution, regulatory activities, and cross-functional collaboration. This role requires strong clinical judgment, a deep understanding of therapeutic development, and the ability to guide complex programs in a dynamic environment.

Contribute to clinical development strategies, including study design, protocol development, execution planning, and interpretation of clinical trial results.

Support proof-of-concept and later-stage clinical programs by providing medical guidance throughout the development lifecycle.

Collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, Biostatistics, Safety, and other development functions to ensure effective trial execution.

Provide medical and scientific input for regulatory documents, including IND submissions, investigator brochures, clinical study reports, and health authority responses.

Ensure compliance with global regulatory standards, Good Clinical Practice (GCP), and applicable requirements for clinical development activities.

Participate in safety monitoring activities, data review processes, and risk assessments to protect study participants.

Represent clinical development efforts in discussions with investigators, key opinion leaders, regulatory agencies, and other external stakeholders.

Support additional strategic and operational initiatives as needed to advance clinical programs.

Requirements

• An experienced physician leader with a strong background in clinical development within biotechnology or pharmaceutical environments.
• Expertise in immunology or inflammation, strong scientific communication skills, and the ability to manage complex global development initiatives.
• MD or equivalent medical degree required.
• 4+ years of clinical development experience within the pharmaceutical or biotechnology industry.
• Experience supporting immunology and inflammation (I&I) indications, with rheumatology experience strongly preferred.
• Experience with antibody therapeutics and innovative biologic therapies preferred.
• Proven experience designing, executing, and interpreting clinical trials.
• A strong understanding of clinical trial methodology, statistics, GCP requirements, and global regulatory processes.
• Experience preparing regulatory submissions and interacting with health authorities.
• Ability to provide strategic medical guidance and collaborate effectively with multidisciplinary teams.
• Excellent communication, leadership, and interpersonal skills with the ability to influence internal and external stakeholders.
• Strong project management capabilities with the ability to prioritize and manage complex initiatives in a fast-paced environment.

Benefits

• Competitive compensation package with a salary range of $343,000 - $365,000 USD, depending on experience, qualifications, and location.
• Performance bonus opportunities.
• Equity grant opportunities.
• Comprehensive health, welfare, and retirement benefits.
• Unlimited paid time off.
• Two company-wide one-week shutdown periods each year.
• Remote working environment with opportunities for in-person collaboration and team meetings.
• Professional development opportunities to support continuous learning and career growth.
• Opportunity to contribute to the development of meaningful therapies that address significant patient needs.
• Collaborative and innovative environment within a growing biotechnology organization.