- Translational Medicine (early clinical projects):
- Develop high value decision-strategies for the Translational Medicine component of drug development projects from Research to clinical Proof of Concept or Proof of Mechanism in a single or multiple indications.
- Develop and implement study protocols for different types of clinical studies (First in Human, Proof of Concept, mechanistic and safety studies), and other documents such as investigators brochures.
- Responsible for clinical monitoring and integrated safety data review during and after the live phase of a study
- Represent clinical Translational Medicine aspects to Health Authorities and other stakeholders (e.g. payers, patient advocacy groups)
- Innovation: Champion and drive new clinical compound characterization opportunities and profiling approaches
- Responsible for implementing studies during the Proof of Concept phase by providing medical and scientific leadership and expertise to all line functions on the project team. This may include methodology studies to identify and validate novel endpoints for early decision making in Proof of Concept studies.
- Communicate clinical team matters to Global Project Teams, relevant BioMedical Research and Development boards, and other Novartis Boards as required.
- Evaluate clinical centers and foster communication with crucial collaborating investigators, regulatory authorities, and other stakeholders
- The work environment is in a matrix structure with cross-functional members from Translational Medicine, Biomedical Research and Development.
- Design and implementation of early Clinical Development Plan and studies according to the Integrated Development Plan / Clinical Development Plan / Clinical Pharmacology Plan enabling efficient and rational decision-making, high probability of fast drug registration, favorable drug label and high competitiveness of compounds
- This role has a key impact on the entire Novartis pipeline, transitioning programs from preclinical through early clinical and ultimately to full development via the Proof of Concept mechanism, and driving the program after Proof of Concept by delivering key Profiling data to support regulatory submissions
- As a recognized specialist in neuroimmunology or neurodegeneration, you drive the project team clinical strategy. Works globally across various Novartis divisions as well as country organizations as appropriate
- Medical Degree (MD) required and advanced training in neuroscience, neuroimmunology and/or neurodegeneration.
- Expertise in translational or laboratory research. PhD preferred but not required
- Record of drug submissions / approval and / or high quality publications in international scientific journals.
- 5 plus years of prior relevant & significant clinical study experience: either from pharma/biotech leading early phase clinical trials; a senior role within a CRO responsible for managing the medical relationship with Sponsors; from a relevant academic medical center with PI & co-PI clinical trial experience.
- Excellent written and oral communication/presentation skills.
- Demonstrated passion for science
- Recognized medical expertise, as evidenced by publication of significant contributions to a field over time
- Innovation: Seeks out new clinical discovery opportunities and clinical development approaches.
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Medical Director, Neuroscience Translational Medicine - Cambridge, United States - Novartis AG
Description
About the RoleThis role is located at our Cambridge, MA site and will not have the ability to be located remotely.
#L1-Hybrid
About the role:
More than a billion people are affected by diseases of the nervous system having a dramatic impact on patients and families around the world.
As part of the Neuroscience (NS) departments at Novartis, you will help to develop therapies for patients with neuroimmune and neurodegenerative disorders.
You will provide medical and scientific leadership and expertise in a role that significantly affects the entire Novartis NS pipeline.
Your responsibilities will include:
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.
Role RequirementsEssential Requirements:
Desirable Requirements:
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world.
How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions.Be a part of this mission and join us Learn more here:
You'll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
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.
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 [email protected] call and let us know the nature of your request and your contact information.
Please include the job requisition number in your message.Novartis Compensation and Benefit Summary:
The pay range for this position at commencement of employment is expected to be between $257,600 - $386,400/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period.
Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities.
The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered.
Details of participation in these benefit plans will be provided if an employee receives an offer of employment.If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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:
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
