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 trai