Director, Clinical Sciences, Therapeutic Lead

Band

Level 6

Job Description Summary

#LI-Hybrid

Novartis has an incredible opportunity for a talented individual to join our team as a Director, Clinical Sciences, Therapeutic Lead. As the Director, Clinical Sciences, Therapeutic Lead you will supports US efforts in the planning, implementation, execution and reporting of US Medical Affairs assigned therapeutic area(s) clinical trials and activities.

The ideal location for this role is at the East Hanover, NJ site but remote work may be possible (there may be some restrictions based on legal entity). The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 25% travel.

Job Description

Key Responsibilities:

• Co-develops clinical program strategy with MST Lead/Medical Director of assigned clinical programs/therapeutic area(s) 
• Serves as clinical lead on MST and works directly with cross-functional team to advance clinical trials, programs, and strategy.  
• Leads overall clinical research activities and provides operational expertise in the execution of Therapeutic Area CS portfolio  
• Responsible for the execution and implementation of clinical trial activities of designated clinical programs.  
• Oversees and manages a US team of trial leads in the execution of clinical research activities  
• Supports recruitment and talent retention; coaches and develops associates to enable them to provide the highest levels of scientific and technical capabilities. 
• Oversees activities performed by team of NOCC associates assigned to TA to ensure seamless execution of clinical trial activities  
• Collaborates with Head, CS & TA & NOCC leads to appropriately resource for TA book of work 
• Tracks and communicates key team achievements and deliverables to ED/Head, Clinical Sciences & Trial Acceleration and other key leaders in the organization. 
• Manages stakeholders across the organization and serves as main CS POC for assigned TA 
• Supports all scientific and operational aspects of clinical trial(s) and program level activities as assigned, including overall vendor, budget, and drug supply management of assigned TA.  
• May attend Investigator/regional meetings, advisory boards, steering committees, professional meetings, and congresses to support clinical programs as needed. Contributes to the preparation and review of clinical program documents (PowerPoint presentations, IND annual report, Health Authority (HA) briefing books, clinical study protocol, regulatory documents, clinical study reports, (CSR) and submissions) and other study related documents assuring quality and consistency.  
• Understands and complies with company SOPs and GCP's; contributes to continuous improvement in SOPs and local Working Practices.

Essential Requirements:

• Bachelors in a science related field is required, Master's Degree or PhD in a science related field preferred or equivalent certification/licensure from an appropriately accredited institution. 
• Prior experience leading high priority above-trial process improvement and transformation initiatives
• Minimum 8 years relevant clinical research industry experience that provides the required knowledge, skills and abilities and experience mentoring or training others.
• Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices and applicable Standard Operating Procedures including industry compliance and ethical requirements. 
• Ability to evaluate medical research data and proficient knowledge of medical terminology. 
• Strong oral, written, and presentation skills, with the ability to communicate program strategy, write protocols, review study feasibility and present program updates to senior management.
• Ability to accurately track financial and trial specification requirements and forecast annual financial and drug needs.
• Excellent computer skills: good knowledge of Microsoft Office and PowerPoint and the ability to learn Novartis proprietary software. 
• Ability to utilize problem-solving techniques applicable to constantly changing environment.
• Conducts above activities with minimal oversight, ability to work independently, and direct others. Expert level competency for above activities includes direct managerial responsibilities for multiple associates and or large teams supporting multiple development programs.
• Ability to mentor and train department associates in a positive and effective manner. 
• Strong customer focus. Travel to external scientific meetings. Host external advisory boards and meet with external customers to advance development program objectives.
• Ability to communicate remotely with effective organizational and time management skills. 

Novartis Compensation Summary:

The salary for this position is expected to range between $204,400 and $379,600 per 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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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 call and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$204, $379,600.00

Skills Desired

Clinical Monitoring, Clinical Research, Clinical Trial Protocol, Clinical Trials, Decision Making Skills, Drug Development, Health Sciences, Medical Strategy, Regulatory Compliance

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