Thermo Fisher Scientific
Sr Director, Project Management, Non-Interventional Clinical Trials Team - Remot
Thermo Fisher Scientific, Charlotte, North Carolina, United States, 28269
Sr Director, Project Management, Non-Interventional Clinical Trials Team - Remote in the US Join to apply for the Sr Director, Project Management, Non-Interventional Clinical Trials Team - Remote in the US role at Thermo Fisher Scientific.
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. This role is for the North America region and is remote based. Our Project Delivery colleagues within our PPD clinical research services direct, coordinate and manage the technical and operational aspects of projects, securing the successful completion of clinical trials. This includes collaborating with functional area leads to identify and evaluate fundamental issues on the project and to ensure that solutions are implemented. Project Delivery is vital to helping our customers deliver life-changing therapies. You may engage in diverse initiatives and projects, or be part of a virtual international project team gaining cross-cultural experience. Therapeutic scopes include: infectious and respiratory diseases, oncology/hematology, neurosciences, cardiovascular and metabolic, general medicine and vaccines.
Responsibilities
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. Qualifications / Keys to Success
Education : Bachelor's degree or equivalent and relevant formal academic / vocational qualification Experience : 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 Knowledge, Skills, Abilities :
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 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
Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. The working environment/requirements for this role: 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.) We’re supporting a mission to enable our customers to make the world healthier, cleaner and safer. Our global team of 100,000+ colleagues share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
A high number of candidates may make applications for this position, so make sure to send your CV and application through as soon as possible. #J-18808-Ljbffr Remote working/work at home options are available for this role.
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. Qualifications / Keys to Success
Education : Bachelor's degree or equivalent and relevant formal academic / vocational qualification Experience : 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 Knowledge, Skills, Abilities :
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 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
Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. The working environment/requirements for this role: 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.) We’re supporting a mission to enable our customers to make the world healthier, cleaner and safer. Our global team of 100,000+ colleagues share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
A high number of candidates may make applications for this position, so make sure to send your CV and application through as soon as possible. #J-18808-Ljbffr Remote working/work at home options are available for this role.