Director, Clinical Development AID

Role Summary

Director will provide clinical and scientific input and medical monitoring to early-stage clinical development programs in autoimmune diseases. The role includes significant clinical study oversight, review of patient data, input on trial design and execution, and preparation/presentation to leadership, at conferences, and to safety oversight committees.

• Lead the scientific development of individual clinical studies in alignment with the clinical development plan, including authoring and reviewing clinical documents (e.g., protocols, investigators brochure, eCRFs, ICFs, CSRs)
• Perform review of clinical trial data (safety and efficacy), including medical monitoring and assessing for consistency and completeness and providing assessments and recommendations
• Serve as the clinical development lead during the conduct of the study
• Communicate a clear overview of trial results
• Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables
• Review and synthesize scientific literature and competitive intelligence to support study and program strategy
• Develop scientific and protocol training presentations to support internal and external meetings; e.g., site qualification and initiation, investigator meetings, and training materials
• Drive and support preparation of scientific material for conference presentations or publications
• Contribute to the authoring and revision of regulatory submissions
• Perform analyses and generate scientific slide decks based on clinical, translational and other datasets

• Required:
  
  Medical Doctorate (MD, DO, MBBS)
• Required:
  
  Advanced clinical training or a scientific degree in immunology (e.g., PhD, Pharm
  
  D, MPH) a plus
• Required:
  
  8+ years of previous experience in clinical or related research
• Required:
  
  Excellent oral and written communication skills and analytical skills
• Required:
  
  Ability to work collaboratively in a fast-paced, team-based matrix environment; ability to assume multiple roles and responsibilities and meet stretch goals
• Required:
  
  Familiarity with ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators
• Preferred: MD with a strong clinical or biopharmaceutical background in caring for patients with autoimmune diseases
• Preferred:
  Clinical or research experience in immunology or neurology

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit – Proactive. Ownership mindset.