Immunology Clinical Development Consultant

This position is a key member of the Small Molecule Team, providing clinical and medical leadership for the program's strategy across all stages of development, from Phase 1 and Proof-of-Concept studies to later phases.

The candidate will support the medical aspects of submission, approval, and commercialization of drug candidates aimed at treating various autoimmune diseases.

Requirements :

We seek a seasoned professional with extensive expertise in immunology and rheumatology, as well as drug development in this therapeutic area.

The ideal candidate will possess strong leadership skills and a proven track record of successfully bringing innovative therapies to market.

Key Responsibilities :

Drug Development :

• Provide medical / clinical oversight for Phase 1 and Proof-of-Concept studies, including data review, interpretation, and site communication.
• Author and ensure the quality of abstracts, manuscripts, study reports, regulatory communications, and site or safety communications (in collaboration with pharmacovigilance).
• Design and implement clinical development strategies and protocols.
• Support medical monitoring, trial execution, and safety / tolerability determination.
• Represent Annexon and the ANX007 program in external engagements with CROs, consultants, and sites.
• Oversee the execution of clinical trials in collaboration with Clinical Operations and Medical, ensuring compliance with regulatory requirements, ethical standards, and timelines.
• Serve as the Immunology and Rheumatology leader, partnering with the Program Team Leader and heads of development operations, clinical operations, pharmacovigilance, clinical quality, and biostatistics.
• Provide medical leadership for site selection, feasibility, enrollment, issue resolution, and data quality.
• Support business development activities in Immunology.
• Participate in the C1s Oral Small Molecule Core Team and Development Leadership Team to develop and execute a strategic plan for ANX1502 and its follow-on molecules.
• Collaborate with the Research function to leverage aspects of drug discovery into development programs.
• Guide decision-making and optimize study design and execution through scientific and clinical expertise.
• Collaborate with Medical Affairs for KOL engagement, Advisory Committee interactions, and Steering Team meetings.
• Drive innovation and differentiation of drug candidates based on current and future program data.
• Develop and execute robust regulatory strategies in collaboration with Regulatory Affairs and the ANX1502 Program team.
• Interface with regulatory authorities for successful regulatory submissions and approvals.
• Stay updated on evolving regulatory guidelines and requirements for immunologic drug development.

Cross-Functional Collaboration :

• Foster strong collaboration across R&D, clinical development, Translational Medicine, regulatory affairs, commercial, and other relevant departments.
• Act as a liaison between the Immunology team and executive leadership, providing regular updates on portfolio progress and strategic initiatives.
• Promote a culture of teamwork, innovation, and accountability within the organization.

Key Qualifications :

• Advanced degree in medicine or a related field; Medical Degree with subspecialty training and practice in Immunology and Rheumatology preferred.
• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, focusing on Immunology and Rheumatology drug development.
• Proven leadership in Immunology, including successful development and commercialization of immunologic or rheumatologic products.
• In-depth understanding of immunologic diseases, drug development processes, and regulatory requirements.
• Demonstrated ability to develop and execute strategic plans, drive innovation, and deliver results in a dynamic environment.
• Strong leadership and interpersonal skills, with the ability to inspire and influence teams at all levels.
• Excellent communication and presentation skills, capable of articulating complex scientific and clinical concepts to diverse audiences.
• Experience interacting with regulatory authorities and leading successful regulatory submissions and approvals.
• Business acumen and strategic thinking, with a focus on maximizing the commercial potential of ophthalmology products.
• The midpoint salary for this role is $220,000 with flex up or down depending on experience*
24 days ago