Jul 29, 2022

Job Description

60! With 60-year history in neuroscience, Novartis brought landmark therapies to patients with Multiple Sclerosis, Alzheimer’s disease, Parkinson’s Disease, Epilepsy, Depression and Migraine. We have a world-class pipeline in neuro-inflammation, neurodegeneration, psychiatric and neuromuscular diseases. Our holistic R&D approach includes cutting edge molecules, comprehensive approaches to technology, biomarker and digital therapeutics to propose better solutions for patients worldwide.

As our Biomarker (Sr) Clinical Development (**Medical) Director (Sr/CDD or Sr/CDMD), you will support the establishment the Neurosciences biomarker strategy and clinical teams in the implementation of this strategy. You will also drive collaboration with internal and external experts to develop and analyze innovative biomarkers spanning molecular, cellular, imaging and digital device modalities.
Your responsibilities include, but are not limited to:

• Define the overall neuroscience biomarkers strategy in terms of fluid, imaging and digital biomarkers.
• Provide guidance and support to clinical teams in defining program specific biomarker strategy and its implementation. As such you provide clinical and scientific input and contribute to clinical sections of trial and program level regulatory documents (e.g., Clinical Development plan, Investigator’s Brochures, Health Authority briefing books, study protocols, Clinical Trial Applications (CTA) submission dossiers, and responses to Health Authorities).
• Drive and manage collaboration with internal and external experts for the development if neuroscience biomarkers.
• Represent Novartis at industry consortia and collaborations with external groups working on developing neuroscience relevant biomarkers.

• In collaboration with appropriate Clinical Trial Team (CTT) members: Ensure clinical support of trials as needed; conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead; manage patient safety reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), GCT, GPT) with appropriate oversight from Medical Lead; provide input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations.
• Support Therapeutic Area Head (TAH) with contributing to peer-review of IDPs, CTPs, and other clinical documents across various indications and programs, and support development of TA strategies, as needed.
• May contribute to the medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities.
• Contribute to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support; develop and foster CD culture; and may contribute to the performance evaluation of CTT members.
• Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training.
• Contribute to global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives).

Diversity & Inclusion / EEO

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 Ph.D OR MD/PhD with minimum of 5 years of correlative science in Neurosciences, of which a minimum of 2 years must be in Pharmaceutical industry.
• Broad neuroscience biomarkers expertise.
• Interest and expertise in the development and utilisation of fluid biomarkers (e.g. neurofilaments) required.
• Interest and expertise in imaging (e.g., MRI) and digital biomarkers 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; 2 or more 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.
• Proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level.
• Working knowledge of the disease area (Neuroscience) with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
• Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes.

**Final job title (Clinical Development Medical Director - CDMD/ Clinical Development Director - CDD, Band 3 OR Senior CDMD/ Senior CDD, Band 3) and associated responsibilities will be commensurate with the successful candidates’ level of expertise.

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 never trying!
Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. 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.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
Research & Development
Full Time
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(Snr*) Clinical Development (**Medical) Director, Neuroscience

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