Senior Medical Director, Autoimmune

Job Title: Senior Medical Director, Autoimmune

Job Number: 33745

Location: Remote, 

Job Description

As a Senior or Executive Medical Director under the Autoimmune Franchise,  you will report to the SVP, Clinical Sciences to provide broad scientific and/or medical input to activities that span across the scope of autoimmune disease clinical research, including contribute to/lead the strategic planning and execution of clinical research plans, provide medical support of regulatory submissions, contribute and provide medical input to commercial initiatives and medical affairs.

Responsibilities

• Medical oversight for planned and future clinical trials throughout- conduct and support of all medical and scientific aspects of clinical trial (s) and program level activities as assigned, including interpretation of results, clinical study reports and graphical displays
• Ensure appropriate scientific rigor in the design, conduct, validity and interpretation of clinical trials using CAR-T therapies in autoimmune diseases that benefit from B cell depletion therapy to support regulatory applications or future business/marketing objectives. This role will support ongoing planning for the development of cell-based therapies across autoimmune and oncology disease indications
• Contribute to the strategic planning, authoring, and review of regulatory documents, scientific data disclosures, and commercial support documents
• Conduct and have oversight over medical monitoring activities and co-lead interactions with the Data Safety Monitoring Committee
• Identify significant issues that may impact overall project plans and initiate contingency plans as appropriate
• Provide medical expertise and support to externally facing groups/stakeholders, including the field medical team, medical information and the commercial organization
• Maintain close collaboration and cooperation with clinical operations on the implementation and execution of clinical studies
• Contribute and be responsible to the development planning, authoring and review of manuscripts and other scientific data disclosures
• Contribute to departmental resource planning, budgeting and timeline setting to meet company needs
• Serve as a medical interface to key opinion leaders (KOL), facilitating KOL advocacy development

Required Skills

• MD degree with a minimum of 5 years of combined medical practice and biotechnology or pharmaceutical industry experience in Clinical Research
• Prior experience in Rheumatology, Immunology or Nephrology or relevant/related experience with board certification in one of these specialties
• Deep understanding of and direct clinical experience in the treatment of autoimmune diseases such as SLE, autoimmune renal diseases and other potential diseases. Broad and deep understanding of approved and investigational therapies for these diseases
• Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements
• Demonstrated ability as a medical expert in a complex matrix environment