Clinical Development Medical Director, Gene Therapies
Job Description 300 million people worldwide are affected by rare genetic diseases. Since 2013, Novartis Gene Therapies (formerly AveXis) has one focus: bringing change to those devastated by a rare genetic disease which frequently affect the nervous system with chronic, progressive, and degenerative pathology that disproportionately (~ 83%) affects children.
Your responsibilities as a Clinical Development Medical Director (CDMD) for Gene Therapies include, but not limited to:
*Provide clinical leadership and medical strategic input for all clinical deliverables (e.g. clinical sections of individual protocols, Integrated Development Plans, clinical data review, regulatory documents/registration dossiers, and publications).
*Lead development of clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
*May act as study medical monitor
*Support (Sr.) Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and support overall program safety reporting in collaboration with Patient Safety
*As a medical expert, support the (Sr.) GPCH or Clinical Development Head (CDH) in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., Clinical Trial Team, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
*May work with Novartis Institutes for BioMedical Research (NIBR) / Translational Medical Sciences to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed
*Ensure career development of Program reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, & mentoring support
This role can be based in East Hanover, NJ, Chicago, or Cambridge, MA. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Minimum requirements What you'll bring to the role:
*MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., preferably Neurology, Pediatrics, Genetics or background in CNS drug development ) required, with Medical Board certification preferred; Clinical practice experience 4 years (including residency) preferred
*5 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. 3 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
*Advanced knowledge of assigned therapeutic area
*People management experience preferred; this may include management in a matrix environment. Global people management experience preferred
*Some restrictions on flexible working may apply and will be discussed at interview, if applicable
766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
What Novartis can offer you?
Yes, we offer exceptional benefits and competitive salaries. However, we can offer more. Here you will:
*Get access to latest technologies and work with talented scientists
*Virtually learn and earn certificates from 190 universities around the world, all supported by Novartis through our partner Coursera.
*Get access to the Novartis Learning Institute which offers personal effectiveness, digital capability and language programs, as well as talent acceleration and leadership programs.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team representative of the patients and communities we serve.
Accessibility and reasonable accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Division Global Drug Development Company/Legal Entity Novartis Pharmaceuticals Alternative Country 1 Switzerland Alternative Country 2 United Kingdom Functional Area Research & Development
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Novartis Group Companies
July 03, 2022