Director, Translational Medicine
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 Director, Translational Medicine is responsible for the successful translation of gene therapy products from the pre-clinical proof of concept stage in Research and Early Development to first-in human trials.
- Works with a cross-functional team on specific pipeline programs to evaluate and ensure trial readiness in regards to natural history datasets, biomarkers and clinical outcomes.
- Engages with key stakeholders including clinicians, researchers and patient groups to better understand disease burden, unmet needs, meaningful endpoints, acceptable and feasible clinical development strategies, pathways to rapid diagnosis, as well as opportunities to partner towards the shared goal of finding better treatment.
- In collaboration with Translational Medicine team members, designs innovative and potentially label-enabling first-in human trials as well as phase 1 and 2 clinical trials, natural history studies and observational studies.
- Ensures that translational medicine contributions to Investigational New Drug (IND) submissions are planned and executed in a timely manner.
- Works in cross-functional teams and serves as the primary Translational Medicine interface to peers in Research, Biomarker Development, Precision Medicine, and the Novartis Institutes for BioMedical Research Musculoskeletal and Neurosciences groups with a focus on biomarker planning, platform issues including vector design, delivery, pre-clinical studies and alignment with clinical trial design.
- Liaises with clinical development, clinical operations, regulatory, CMC, project management, and business development functions.
- Maintains scientific awareness regarding advances in indications of interest, regulatory awareness regarding new guidance and rules, and industry awareness regarding trends and competition through literature, conferences and stakeholder interactions.
- Other related job duties as assigned.
- Master's degree in Life Sciences, Biology, or other relevant life sciences, with 8 years years' of relevant translational or clinical research experience, or Doctorate (or similar degree) in Life Sciences, Biology, or other relevant life sciences, with 5 years relevant translational or clinical research experience.
- Proven ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
- Ability to excel in a multidisciplinary environment as an integral team member across several project teams.
- Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
- Knowledge of neurology, genetics and/or rare diseases is preferred.
- Strong understanding of translational medicine, drug development and regulatory issues is desirable.
- Demonstrated excellence in the coordination of translational and/or clinical research projects.
- Background and interest in relevant science and technology are preferred, as are bio/pharmaceutical industry or IND experience.
- True care and passion for improving the lives of people living with rare diseases.
- Diplomacy and professionalism, ability to command respect from peers, and capable of highly independent work as well as being a team player and role model.
- Excellent verbal and written communication skills, allowing for an open and effective dialogue throughout the company and for representation of the company at external events.
- Strong problem-solving ability with attention to timelines, detail and quality.
- Highly motivated and results-oriented with the flexibility and creativity to excel in and contribute to multiple projects simultaneously in a rapidly growing company.
- Must have the passion and ability to forge and nurture key partnerships and collaborations with the external scientific community including academia, governmental organizations, nonprofit organizations and contract research organizations.
- Travel estimated at 30%, most being domestic and some international.
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.