Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.
The Senior Medical Director of Drug Safety and Pharmacovigilance (DSPV) will report to the Vice President, DSPV. The individual will be responsible for providing oversight and management of activities pertaining to Immunovant’s product safety and pharmacovigilance in clinical development and post-marketing surveillance.
The Senior Medical Director, DSPV will have responsibilities for pre- and post-marketing safety, PV and risk management activities. The incumbent in this position must effectively interface cross-functionally at all levels in the organization as well as with external regulatory authorities. The Senior Medical Director, DSPV oversees and is responsible for the integration of pre-and post-marketing safety surveillance with Clinical Development and Medical Affairs activities and for ensuring an integrated and proactive approach to risk management.
- Provide medical and scientific expertise in all aspects of Drug Safety and Pharmacovigilance, including safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks
- Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment and clinical trial data interpretation
- Collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues, including contributing authorship and review of Investigator Brochures, development plans, clinical protocols, INDs/CTAs, regulatory responses and risk management plans.
- Provide oversight and input to aggregate safety reports (e.g. development safety update reports, periodic benefit risk evaluation reports).
- Oversee serious adverse event handling, including individual case reviews, assessment of expectedness and relatedness, and collaboration with Regulatory on expedited reports, as appropriate.
- Participate as a standing member of the Safety Review Committee
- Support internal PV Operations function.
- Support the recruitment, training and professional development of DSPV personnel.
- Oversee drug safety and pharmacovigilance activities conducted in partnership with external business partners or outsourced to vendors and contract research organizations
- Ensure audit and inspection readiness of the function at all times
- Provide expertise on development of Standard Operating Procedures, Working Instructions and other guidance documents.
- MD or equivalent degree; specialty training preferred.
- 10+ years of relevant industry experience, including 4+ years of experience in Drug Safety and Pharmacovigilance
- Oversight experience of global medical safety activities, operations, and risk management strategies in pre and post marketing environments
- Experience with global regulatory filings
- Demonstrated knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments
- Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels
- Experience with MedDRA coding, AoSE, and SMQs
- Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
- Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a team
- Strong interpersonal skills including verbal and written communication
- Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines, including Good Clinical Practices (GCP) guidelines
- Dynamic, fast-paced, entrepreneurial and highly collaborative environment
- Immunovant’s headquarters is located in New York City. The position is flexible for remote work
- Domestic travel required (up to 10%)