Executive Director/Senior Director, Medical Director MD – Immune or Neuro Immune

Role Summary

Medical expert responsible for the development of clinical research strategies and independent direction of Phase 1-3 clinical studies in immune-driven and/or neuro immune-driven diseases, while working with cross-functional project teams to create and execute clinical development plans that lead to approvals. Experience with biomolecules, such as therapeutic antibodies, is required. Provide expert medical advice to advance the development portfolio and help navigate the drug development landscape. Collaborates with Research and Preclinical Development to develop biomarkers for evaluating novel molecules in early development.

Responsibilities

• For assigned programs, develop clinical development strategies and design clinical trials in Development; prepare clinical study synopses; contribute to writing protocols/major amendments; design data collection systems; interpret clinical data; prepare final clinical study reports; engage external experts as needed.
• Represent Medical/Clinical on the cross-functional Program Team as the Program/Therapeutic Medical Lead; provide medical input to integrated development plans and underpin clinical development plans; collaborate cross-functionally to support medical activities for clinical studies.
• Provide medical leadership to the Program Team; drive execution of the clinical development plan.
• Develop and implement study protocols with a multidisciplinary Development Team.
• Assist in identifying and selecting clinical investigators and maintain communications as Sponsor medical monitor/representative.
• Conduct medical assessment and disposition of adverse events with Drug Safety; evaluate safety of clinical compounds during ongoing studies.
• Oversee the clinical trials program with Clinical Operations in accordance with SOPs, GCP, and applicable regulations.
• Identify resource requirements; lead budget planning and personnel forecasting; contribute to recruitment, training, and development of clinical teams; identify and select clinical consultants as needed.
• Lead analysis, interpretation, and presentation of results of assigned clinical studies to internal and external audiences.
• Collaborate with Medical Affairs and external opinion leaders to secure new collaborators and present trial results.
• Interface with Research, Product Development and Business Development to assess new product opportunities and develop clinical research strategy and product development plans.
• Other duties as assigned.

Qualifications

• MD/DO and 6+ years of experience combining clinical practice and Medical Affairs or related pharmaceutical consulting.
• Preferred experience in Psychiatry, Neurology, or Movement Disorders.
• Recognized internal thought leader with deep expertise in immune-driven diseases.
• Broad, deep expertise in leading-edge theories and techniques for the functional area.
• Creativity in problem analysis and resolution for complex or novel situations; ability to influence internal/external business and industry issues.
• Strong mentoring and leadership abilities; proven ability to translate strategy into tactical plans and drive outcomes.
• Flexible, adaptable, self-motivated; able to prioritize and manage a large workload with minimal supervision.
• Strong interpersonal and collaborative skills; proven track record building relationships with medical/scientific experts.
• Excellent oral and written communication; ability to translate complex concepts for different audiences.
• Project management experience; proficiency with word processing, spreadsheets, databases, and presentation software; familiarity with filing/archiving systems.
• Deep knowledge of the drug development process, technical, regulatory issues; track record with regulatory agencies and leading IND/NDAs filings.
• Strong knowledge of Good Clinical Practice and regulatory procedures for investigational drug development.
• Knowledge in translational medicine, biomarker evaluation, clinical study execution, regulatory requirements, biostatistics, data analysis, and scientific data presentation.
• Ability to operate effectively in a multi-level matrix environment with clinical research teams and external partners.
• Demonstrated success managing interactions with CROs, consultants, and contract organizations in a small group context.
• Experience driving program strategy, launch, and project management within Clinical Development; experience developing and implementing policies/processes.

Skills

• Medical leadership in clinical development
• Clinical trial design and execution
• Regulatory strategy and interactions
• Biomarker development and translational medicine
• Stakeholder management and cross-functional collaboration
• Data interpretation and scientific communication

Education

• MD/DO degree

Additional Requirements

• No specific travel or physical demands provided in the source.