Sr Director, Project Management, Non-Interventional Clinical Trials Team - Remote in the US
- May manage staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
- Accountable for strategic indication or client-specific portfolio management within a Therapeutic Unit?.
- Serves as senior level or executive contact.
- May review financial forecasting of TA.
- Acts as a Champion for organizational changes, offerings, developments and lead workstreams.
- Expertly navigates the need to dive in/dive out of situations while ensuring the Project Lead remains empowered.
- Provokes critical thinking and drives innovation in Project Lead related to execution of delivery, financial negotiations and prioritization?.
- Provides insight into proposal strategy in prep for bid defense?.
- Initiates collaboration with Therapeutic Unit Head in development and implementation of business growth strategies.
- Maintains awareness and engages as appropriate in the Con Mod process.
- Communicates with People Manager(s) to support the development of the employee? providing expertise and perspective related to client needs, indication and therapeutic knowledge.
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ years).
- 7+ years of management responsibility
- Advanced leadership skills
- Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
- Advanced, broad understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC, publishing, etc.
- Advanced understanding of medical terminology, statistical concepts, and guidelines
- Outstanding analytical, investigative, and problem-solving skills, including complex evaluations of intangible variables
- Expert financial acumen with an in-depth of knowledge and practical application of budgeting, forecasting and resource management
- Accomplished executive presence and consultation and presentation skills
- Superior critical and strategic thinking skills that accounts for a broad impact
- Excellent coaching and leadership skills
- Exceptional customer service, relationship building and stakeholder management skills
- Expert negotiation and marketing skills with ability to influence others and drive results
- Superior judgment, decision making, escalation and risk management skills
- Proven ability to drive corporate strategies to capture, engage and retain repeat customers
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel. (Recruiter will provide more details.)
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