Senior Medical Director

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Senior Medical Director is responsible for design, conduct, execution and reporting of clinical studies in rare neurologic conditions.

Responsibilities

• Works collaboratively with line management and other functional lines to develop coordinated and aligned clinical plans.
• Contributes to global regulatory submissions, providing written and verbal clinical, clinical development and scientific input.
• Serves as an interface with regulatory, clinical operations, manufacturing, commercial, and medical affairs groups to appropriately communicate information and assure coordinated delivery on goals.
• 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.
• Partners with Clinical Operations to ensure all clinical study activities are completed efficiently and on time in accordance with applicable regulations and guidance.
• Reviews clinical data from all phases of development and assist in generating study reports, publications and regulatory documents.
• Coordinates, and provides 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.
• Serves as study medical monitor, as needed.
• Identifies and manages external collaborators, investigators, key clinical academic experts and consultants.
• Provide management personnel with timely updates on progress and proposed changes in scope, schedule, and resources as required.
• Develop and implement SOPs for clinical trials and related activities, as required.
• Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians.
• Develop and maintain professional relationships with academic and community-based study sites.
• Interface with departments within and outside of R&D including Finance, Regulatory Affairs, Commercial, Legal Affairs and Medical Affairs.
• Acquire and share publicly available knowledge of competitor products and clinical plans.
• Incorporate Health Economics Outcomes Research requirements into protocol design.
• May manage 1-3 other employees.
• Other related job duties as assigned.

Qualifications

• Medical Degree (MD) with added qualifications in Neurology, Pediatrics, Genetics or CNS background.
• 3 years of relevant experience in drug development at a biotech/ pharmaceutical company. Experience in academic clinical trials but without industry experience may be considered at the Medical Director level.
• Preferred: Additional postdoctoral training or additional qualifications such as PhD, PharmD, certificate in Pharmaceutical Medicine.
• Clinical or research experience with Neuromuscular Disorders or other rare neurologic disorders.
• Demonstrable working knowledge of regulatory procedures and guidelines in the U.S.
• Proven record of accomplishment in clinical study design, monitoring and execution and results analysis.
• Demonstrated knowledge of designing, implementing and conducting clinical studies, to produce both timely and good quality data.
• Proven record of working on teams and in a matrix environment.
• Preferred: Additional postdoctoral training or additional qualifications such as PhD, PharmD, certificate in Pharmaceutical Medicine.
• Prior experience in EU/US regulatory filing.
• Experience in development of orphan drug products, neurology products, especially orphan neurology products.
• Demonstrable working knowledge of regulatory procedures and guidelines in all geographic regions (global scope).

The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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