摘要
About the Role
About the role:
Your Key Responsibilities:
- As Country Clinical expert and member of core GCT, supports GPCH (dotted reporting line function) or CDH and works closely with CDD/CDMD. Is accountable to bring continuous US strategic and executional input into CDPs/concept sheets/protocols/trials and provide insights for clinical / medical / patient perspective about trial design and programs for successful execution in US, inc. diversity.
- Co-leads (CPL & CPM / PTL) local cross-functional trial team Country Program Team (Local CPT) to ensure close collaboration and clear Roles & Responsibilities between SSO and MA to support GDD trials.
- Accountable for essential clinical/medical activities for Development and Biomedical Research priority clinical trials including feasibility, clinical/medical recruitment activities, protocol execution in US including answering protocol related questions and addressing critical safety related topics.
- Ensures program specific global CRMA excellence and bidirectional communication from CRMA community to GCT (indication / protocol / competitor trainings, clinical medical recruitment activities, lessons learned etc.) with support from assigned regional CRMAs.
- Act as the key scientific/clinical/medical point of contact for prioritized GDD clinical trial sites and provides knowledge on the company’s pipeline programs to these sites.
Video Link http://www.youtube.com/watch?v=ggbnzRY9z8w
Location: Remote
Role Requirements:
Essential Requirements:
- Scientific degree M.D./D.O. (preferred); PharmD or PhD with 7+ years clinical development experience in a pharmaceutical industry or clinical practice.
- Training in relevant aspects of clinical drug development including GCP, Country regulatory requirements and data privacy laws.
- Deep clinical development expertise, including study designs, statistical planning, etc.
- Agility to move fast across different therapeutic areas and indications.
- Leadership, strong communication skills and the ability motivate a cross-functional team, lead alignment across line functions and handle and delegate responsibilities.
- Sound understanding of the overall clinical development process, study designs and ICH/GCP principles.
- Demonstrates a knowledge of how to adequately review and read a protocol to understand specifics of study design and answer questions regarding the trial.
- Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care.
- Demonstrates an understanding of the protocol to evaluate compliance on the part of the Investigator/site staff/study participant and any patient safety issues.
Desired Requirements:
- Subspecialty training desirable in, Neuroinflammation or M.S.
Novartis Compensation and Benefit Summary:
The pay range for this position at commencement of employment is expected to be the following:
- Non-M.D. Range: between $236,600 and $386,400/year
- M.D. Range $270,600 and $439,400/year
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
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? http://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & 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 to perform the essential functions of a position, please send an e-mail to [email protected] or 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.
