Clinical Development Medical Director, Car-t 80-100%
Vor 2 Tagen
22 the number of oncology drugs we have on the market and more than 25 new molecular entities in development targeting key molecular pathways in cancer biology. And while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
- As our Clinical Development Medical Director CAR-T, you will be the clinical leader of defined program level activities (e.g. submission activities, briefing books etc.), or a large, complex trial, under the leadership of the (Sr.) GPCH. You may lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase).
- Your responsibilities will include:
- Provide clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of 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)
- Drive execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates if applicable
- Coordinate/conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s)
- May be the Program Manager of other associates (e.g., CSE). Support (Sr.) 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 (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
- Support the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH
- As a medical expert, support the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
- May work with NIBR (Novartis Institute of Biomedical Research)/Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
- MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area required (CAR-T), with Medical Board Certification preferred
- Fluent oral and written English.
- 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 (CAR-T)
- Proven ability to establish strong scientific partnership with key stakeholders
- Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process
- People management experience preferred, this may include management in a matrix environment. Global people management experience desirable
- Excellent negotiation, conflict resolution and communication skills (written and oral). Strong interpersonal skills
Why consider Novartis?
769 million lives were touched by Novartis medicines in 2020, 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
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