Clinical Development Director/ Medical Director, Neuroscience

Global Drug Development       ·      East Hanover, NJ     ·      Full time

348869BR

Job Description

60! With a 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 a Biomarker Senior Clinical Development (PhD) or Senior Clinical Development Medical Director (MD), you lead the establishment for 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.

What you’ll be doing: 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 lead collaboration with internal and external experts for the development if neuroscience 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).
• Represent Novartis at industry consortia and collaborations with external groups working on developing neuroscience relevant biomarkers.

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 Ph.D. with a minimum of 5 years of correlative science in Neurosciences, of which a minimum of 2 years must be in the Pharmaceutical industry.
• Broad neuroscience biomarkers expertise. Interest and expertise in the development and utilization 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.
• 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 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, OR Senior CDMD/ Senior CDD) and associated responsibilities will commensurate with experience.

Why Novartis

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 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!

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com.

Division: Global Drug Development
Business Unit: NEUROSCIENCE DU GDD
Country: USA
Work Location: East Hanover, NJ
Company/Legal Entity: Novartis Pharmaceuticals
Functional Area: Research & Development
Job Type: Full Time
Employment Type: Regular
Shift Work: No
Early Talent: No

Please click here to apply.