Director, Clinical Sciences, Therapeutic Lead

Role Summary

The Director, Clinical Sciences, Therapeutic Lead supports US efforts in the planning, implementation, execution and reporting of US Medical Affairs assigned therapeutic area(s) clinical trials and activities. Location is primarily East Hanover, NJ, with potential for remote work; travel may be required up to 25%.

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 with cross-functional teams 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 high levels of scientific and technical capabilities
• Oversees activities performed by 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
• 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, including vendor, budget, and drug supply management of assigned TA
• May attend investigator/regional meetings, advisory boards, steering committees, professional meetings, and congresses; contributes to preparation and review of clinical program documents and study-related documents
• Understands and complies with SOPs and GCPs; contributes to continuous improvement in SOPs and local practices

Qualifications

• Required: Bachelors in a science-related field; Master's Degree or PhD preferred or equivalent certification/licensure
• Required: Minimum 8 years of relevant clinical research experience with mentoring/training experience
• Required: Excellent understanding of FDA guidelines, Good Clinical Practices and applicable SOPs, including compliance and ethics
• Required: Ability to evaluate medical research data and proficient knowledge of medical terminology
• Required: Strong oral, written, and presentation skills; ability to communicate program strategy, write protocols, review study feasibility and present updates to senior management
• Required: Ability to track financial and trial specification requirements and forecast annual needs
• Required: Proficient computer skills (Microsoft Office, PowerPoint) and ability to learn company software
• Required: Problem-solving ability in a constantly changing environment; able to work independently and guide others
• Preferred: Experience mentoring and training department associates; strong customer focus; ability to travel to external meetings and host advisory boards

Skills

• Strong communication and leadership capabilities
• Financial acumen related to trial budgeting and forecasting
• Operational execution of clinical trial activities
• Cross-functional collaboration and stakeholder management
• Remote communication and time management skills

Education

• Bachelor’s in a science-related field required; Master’s or PhD preferred

Additional Requirements

• Travel up to 25% for domestic and international activities