Senior Medical Director Clinical Development Neurology
Location: Greater Chicago Area
Senior Medical Director Clinical Development Neurology | Growing Gene Therapy Company
This Senior Medical Director Clinical Development search is being conducted on behalf of our client who is focused on advancing cutting-edge science to treat rare and life-threatening genetic diseases. Their initial product has been granted Orphan Drug Designation by the FDA.
The Senior Medical Director will be responsible for design, conduct, execution and reporting of clinical studies in rare neurologic conditions. The Senior Medical Director will need to work collaboratively with line management and other functional lines to develop coordinated and aligned clinical plans. The Senior Medical Director will contribute to global regulatory submissions, providing written and verbal clinical, clinical development and scientific input. The Senior Medical Director will serve as an interface with regulatory, clinical operations, manufacturing, commercial, and medical affairs groups to appropriately communicate information and assure coordinated delivery on goals.
HIGHLIGHTS OF RESPONSIBILITIES:
Provides oversight and management of clinical studies including planning, execution, completion and reporting of clinical trials according to all applicable regulations and guidance, ICH/GCP, and SOPs.
Partner with Clinical Operations to ensure all clinical study activities are completed efficiently and on time in accordance with applicable regulations and guidance.
Review clinical data from all phases of development and assist in generating study reports, publications and regulatory documents.
Coordinate, and provide ongoing assessment, evaluation, and communication with other departments (e.g., Regulatory, Drug Safety, and Clinical Trial Materials) and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are accomplished.
DESIRED SKILLS AND QUALIFICATIONS:
Medical Degree (MD) with added qualifications in Neurology or Pediatrics and a strong scientific background. Additional postdoctoral training or additional qualifications such as PhD, PharmD, certificate in Pharmaceutical Medicine is preferred.
Clinical or research experience with rare neurologic disorders.
At least 2 years of relevant experience in drug development at a biotech/ pharmaceutical company. Candidates with academic clinical trials experience but without industry experience will be considered at the Medical Director level.
Proven track record in clinical study design, monitoring and execution and results analysis.
Proven record of working on teams and in a matrix environment.
To learn more about this opportunity, contact a member of our team at 267-483-5233 or firstname.lastname@example.org.
The Bandish Group, LLC
Life Sciences Executive Search
1432 Easton Road, Suite 2B
Warrington, PA 18976