Clinical Program Lead - Neuroscience

Work set-up: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 

Offer summary

Qualifications:

Medical degree (M.D./D.O.) preferred, or PharmD/PhD with 7+ years of clinical development experience., Training in clinical drug development, including GCP, regulatory requirements, and data privacy laws., Deep expertise in clinical development, study design, and statistical planning., Strong leadership and communication skills with the ability to motivate cross-functional teams..

Key responsibilities:

  • Support and contribute to clinical trial performance, focusing on quality and recruitment.
  • Provide clinical and medical insights into trial design, protocols, and development plans.
  • Lead local cross-functional trial teams to ensure collaboration and clear roles.
  • Act as the scientific and medical contact for clinical trial sites and provide expertise on pipeline programs.

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Novartis XLarge http://www.novartis.com
10001 Employees
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Job description

Job Description Summary

As a US Clinical Program Lead for neuroscience, you will actively contribute to successful trial performance from a clinical quality and recruitment perspective with a focus on clinical activities, drive US insights into GDD trial concept sheets/protocols, clinical development plans and other relevant clinical documents. You will also co-lead a US local cross-functional team to bring alignment of US MA, SSO, and Development on US clinical development program strategy/tactics.


 

Job Description

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  https://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.


 

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 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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com 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.


 

Salary Range

$236,600.00 - $439,400.00


 

Skills Desired

Clinical Trials, Cross-Functional Teams, Data Analysis, Data Monitoring, Drug Development, Drug Discovery, Medical Research, Medical Strategy, People Management

Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • People Management
  • Self-Motivation
  • Communication
  • Leadership

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