A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
◦Provides operational oversight, leadership and strategic input for the execution of clinical trials.
◦Solves operational problems based on sophisticated analytical thought and good judgment.
◦Interprets and anticipates internal and external business challenges and recommends best practices to drive improvement in processes and services.
◦Is recognized as an expert within the discipline and beyond, with peers within the same technical area in the business as well as other key business functions.
◦Serves as best practice resource within own discipline or as technical expert on cross-functional teams or projects.
◦Has in-depth organizational and relevant market knowledge and uses understanding on how relevant areas can be integrated to achieve objectives.
•Leads the development of the clinical trial strategy and delivers the clinical operational plan within the budget, timelines and quality standards agreed upon by Governance Committees.
•Accountable for oversight of CROs in the execution of Phase I – IV global clinical trial(s).
•Represents Global Clinical Operations (GCO) within the Global Trial Team and serves as the key GCO operational point of contact for the trial.
•Accountable for the successful preparation and presentation of operational content at key governance discussions (TARB, ICSC).
•Key contributor to the development of annual trial/project objectives and communicating to relevant line management and Clinical Operations Team.
•Drives and leads the successful execution, oversight and approval of all clinical trial documents and operational plans of global clinical trials using strong project management, leadership, and organizational skills.
•Ensures strong oversight, review and delivery of trial/project CAPAs in order to meet corporate compliance standards and timelines.
•Accountable for partnering with CRO in audit responses and addressing quality issues.
•Provides leadership and contributes to all operational aspects of the trial budget, including forecasts to ensure delivery within the R&D financial standards.
•Performs review and provides strong operational input in the development of clinical trial protocols, ICFs and CSRs and contributes as a member to the CTM Internal Protocol Review Committee.
•Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operational and organizational challenges.
•Supports the development and implementation of department initiatives including input on SOPs, processes, and workstreams.
•Ensures strong inspection readiness application for all assigned clinical trials.
•Manages projects/work streams with high complexity, risk, impact and reach. Manages large-sized global project teams with members also from outside the direct working environment. Coordinates stakeholders from closely related areas and beyond.
•Demonstrates skills in successfully leading international teams in the matrix organization and directs, influences and motivates people; creates and leads a positive working climate.
•Develop and lead operational and therapeutic area training for internal and external study team members.
•Directs multiple studies in parallel and/or be called upon for program management duties.
•Exhibits Subject Matter Expert level understanding of multiple functions and functional processes.
•Accountable for successful project execution including definition of milestones and clarification of project scope. Receives minimal guidance and works independently. Acts as a senior advisor and mentor within the team and beyond and serves as best practice resource within own discipline or as technical expert on cross functional teams or projects.
Matrix Management of people
•Leads Clinical Trial Team (and potentially multiple teams or a sizable team of professionals/team leaders) and is accountable to drive the performance and results of the team within a matrix environment internally and externally as it relates to trial delivery.
•Assess resource needs and makes recommendations for allocations across the trial(s).
Who you are:
Senior Clinical Trial Lead: Advanced degree desirable (MPH, MS, MA, MBA, PharmD); PM certification (CPM, PMP) desirable.
Associate Director, Clinical Trial Lead: Advanced degree desirable (MPH, MS, MA, MBA, PharmD); PM certification (CPM, PMP) desirable.
•Experience in all aspects of clinical study planning and start up (including budget and resource planning), and in executing the complete range of clinical study activities, from start up through final study report.
•Strong leadership competencies and influencing skills.
•Effective oral and written communication skills
•Proven team dynamic knowledge and skills and ability to foster partnerships across projects and multidisciplinary teams.
•Growing expertise in drug development, including some knowledge of interfaces and interdependencies of clinical development with other functions (e.g., nonclinical & pharmaceutical development, regulatory, commercial/marketing)
Senior Clinical Trial Lead
•Minimum of 7 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment with at least 4 years of in-depth knowledge and experience in clinical trial management.
•Extensive experience in all aspects of clinical study planning and startup (including budget and resource planning) and in executing the complete range of clinical study activities, from startup through final study report.
•Requires substantial to extensive professional experience in relevant disciplines and substantial project management experience. Requires senior knowledge and experience in own discipline and beyond which may also require good market and competitor knowledge.
Associate Director, Clinical Trial Lead
•At least 10-12 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment with at least 7 years of in-depth knowledge and experience in clinical trial management including managerial responsibility.
•Proven experience in all aspects of clinical study planning and startup (including budget and resource planning) and in executing the complete range of clinical study activities, from startup through final study report.
•Experience in multiple Therapeutic Areas.
•Requires substantial to extensive professional experience in relevant disciplines and substantial project management experience. Requires expert knowledge and experience in own discipline and beyond which may also require good market and competitor knowledge.
JOB-SPECIFIC COMPETENCIES & SKILLS
•Directs the activities of the study team cross-company and cross-functionally, as it relates to study-level strategy, timelines, goals, and quality.
•Provides direction and input to study budgets; financial management and forecasting; planning & organizing, driving results and problem solving.
•Drives site start-up, subject enrollment, clinical monitoring activities, clinical site compliance and data metrics from CROs, central labs, and other external vendors.
•Supports the team in using appropriate Risk Based Oversight methodology
•Able to form, manage and lead a diverse global team.
•Strong oral and written communication skills.
•Excellent organization and planning skills (demonstrated efficient use of time).
•Ensure all study managment activities will be completed in accordance with SOPs/WI, local regulatory guidance including ICH-GCP; audit & inspection leadership- interviewee & responses.
•Sets priorities, focuses efforts and resources, ensuring that team members and stakeholders are working toward common goals.
•Leads operational strategy planning and management of all study and team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge;
•Provides operational expertise to core protocol creation, ultimately influencing country selection, study conduct and timelines; provides operational strategy input on protocol feasibility.
•Drives protocol development process by providing clinical and operational input (rationale, objectives, design).
•Proactively identifies project challenges and risks and proposes appropriate solutions to issues.
•Establishes agreement around intended outcomes and results as well as assesses and adjusts the organization's priorities.
•As a core member of the Clinical Operations Team and leader of the Clinical Trial Team, aligns clinical trial team with organizational goals and objectives of the Clinical Operations Team and/or Global Program Team.
•Able to identify and define problems, extract key information from data and develop workable solutions for the problems identified, to verify root cause and develop solutions to resolve the problems identified.
•Makes decisions autonomously and demonstrates superior critical thinking skills.
•Anticipates issues/risks, develops mitigations and corrective actions.
•Analyzes clinical study and investigative site risks and implements corrective actions, where required.
•Utilizes data/metrics to establish key performance and quality indicators to oversee performance and anticipate areas of concern across the clinical study continuum.
•Evaluates outputs from various analytical tools for relevancy, thereby enhancing and improving study execution by data driven oversight.
•Provides leadership and demonstrates ability to influence, collaborate and negotiate with internal and external stakeholders.
•Utilizes functional expertise and cross-functional resources proficiently to drive study execution.
•Holds functional teams accountable for deliverables to allow provision of studies that are high quality, on time and within budget.
•Balances scientific and operational/project management with team leadership expertise in order to develop and maintain strong, collaborative relationships with key stakeholders.
•Partners with business leaders and management to resolve competing priorities and issues related to stakeholder management
•Evaluates, selects, and ensures appropriate oversight of Contract Research Organizations (CROs) and other external vendors, leveraging solid relationships with key counterparts.
•Manages vendors/CROs for assigned studies ensuring adherence to defined scope of work and budget while upholding high quality standards.
•Demonstrates knowledge of the infrastructure and operational characteristics of CROs and centralized services.
•Utilizes technology and available sources of data to verify vendors are on target for deliverables in an ongoing manner and strategizes to consolidate and streamline processes
•Ensure strong communication pathways are in place and are utilized across all vendors.
Senior Clinical Trial Lead
•Handles, oversees and prioritizes multiple moderate/complex tasks simultaneously; excellent time management skills; works with minimal supervision; self-directed and proactive
•Can lead up to 2 moderate/complex studies in parallel
•Contributes to non-study -related initiatives in addition to study assignments.
•Ensures studies are running according to plan and expectations, ultimately impacting timely and high-quality delivery of program; directs daily operations of clinical study(ies) to meet expected timelines and achieve milestones while ensuring quality and adhering to budget.
•Manages cross-functional teams and vendors to achieve key performance- and key quality indicators in order to accomplish company and individual goals.
•Presents reports to senior management, including updates on financials, forecasts and timelines with minimal supervision.
•Finds creative solutions to moderate/complex problems and makes suggestions for the improvement of existing processes; quickly modifies behavior and supports others in dealing with changes in the work environment.
•Thinks beyond the confines of own function; considers interfaces and pro-actively fosters cross-functional/global approaches. Proven ability to manage internal and external customers;
•Proven track record of having successfully led or contributed to at least one cross-functional initiative.
•Proven ability to anticipate, recognize, and manage issues: Analyzes clinical study and investigative site risks and implements corrective actions, where required. Proven abiity to apply critical thinking skills.
•Collaborates with vendors and verifies each is meeting expectations according to scope of work and budget. Utilizes technology and available sources of data to verify vendors are on target for deliverables in an ongoing manner and strategizes to consolidate and streamline processes.
•Ability to mentor junior staff.
Associate Director, Clinical Trial Lead
•Handles, oversees and prioritizes multiple complex tasks simultaneously; proficient time management skills; works with minimal/no supervision; highly self-directed and proactive.
•Can lead up to 2 or more complex studies in parallel.
•Contributes to non-study -related initiatives in addition to study assignments. Provides reports to senior management, including updates on financials, forecasts and timelines independently.
•SME level understanding of multiple functions/processes. Is familiar with and considers overall business objectives and company strategy.
•Leads and ensures studies for high priority programs are running according to plan and expectations, ultimately impacting timely and high-quality delivery of program.
•Demonstrates creativity and innovation to support projects from a strategic perspective, able to predict the result of action in advance and evaluate options to achieve goals.
•Finds creative solutions to complex problems and makes suggestions for the improvement of existing processes; quickly modifies behavior and leads others in dealing with changes in the work environment.
•Thinks beyond the confines of own function; considers interfaces and pro-actively leads cross-functional/global approaches. Proven ability to manage internal and external customers; is extremely customer focused, builds relationships and treats them with professionalism.
•Proven track record of having successfully led/contributed to more than one cross-functional initiative with visibility in the global organization.
•Excels at anticipating, recognizing, and managing issues: Analyzes clinical study and investigative site risks and implements corrective actions, where required. Expert critical thinking skills.
•Collaborates with vendors and verifies each is meeting expectations according to scope of work and budget on multiple assigned studies. Leads negotiations with vendors and partners to establish strong rapport and streamlined execution of deliverables.
•Proven ability to mentor junior staff.
Functional Area: Research & Development
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com