Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking a
Therapeutic Strategy Head (TSH)
to work with our Cardiovascular & Metabolic Therapeutic Delivery Unit.
will direct and manage an assigned team of Therapeutic Strategy Lead (TSL) staff who serve as Strategic Therapeutic experts in applying therapeutic knowledge to proposal strategies and drug development opportunities, influencing customers regarding clinical development approaches and decisions. Activities of the TSL's will have a direct impact on increasing sales, serves as a key advisors and partners with the therapeutic operational delivery teams to align strategies and direction to deliver quality results with high focus on therapeutic differentiation. Ensure that employees are trained and individual development is aligned and in place to meet project and organizational needs.
- Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters
- Actively provide guidance and review of the scope of work, objectives, timelines, quality of deliverables, and other clinical project management activities for studies and programs.
- Coach and mentor employees around project planning, project review, risk management and problem solving to ensure global alignment of work practices across the team through the adoption and use of all process and technology tools and improvements by employees.
- Work with the clinical project managers to ensure that project budget(s) meet financial and company goals (realization targets), with a focus on proactively ensuring adherence to change control processes.
- Obtain and provide regular feedback to employees from other clinical project team members and key stakeholders to assist in personal and professional development. May attend project team meeting and site visits in order to support development needs. Identify skill and competency gaps at the individual level and work to craft development plans that will close the gaps
- Proactively manage and mitigate resourcing, project and/or individual needs risks with other management and leadership team member. in order to manage study issues and obstacles.
- Act as a key relationship manager for assigned clients; recommend courses of action regarding client management issues; ensure that plans are implemented following approval by senior management.
- Working with individual staff to identify any quality issues within the study and coaching on resolution of issues, including implementation of corrective action plans and escalation.
- May act as point of contact or oversight for specific customers or programs.
- Provide technical expertise and clinical project management experience to project management and training and process improvement efforts.
- Serve as a project management liaison with other groups within Quintiles.
- Provide consultation to clients on drug development process, strategy, and plans as needed.
- Participate in function and/or corporate initiatives, special project assignments, and as a client liaison or departmental cross-functional liaison.
Bachelor's degree in life sciences or related field and extensive clinical research experience including significant leadership experience, including multi-regional and global focus; or equivalent combination of education, training and experience.
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- Excellent communication and interpersonal skills, including good command of English language
- Excellent organizational and problem solving skills
- Effective team-management skills
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics
- Effective mentoring and training skills
- Ability to balance operational and strategic priorities
- Excellent customer service skills
- Good judgment and decision making skills
- Good understanding of other Quintiles functions and their inter- relationship with Clinical Project Management
- Strong software and computer skills, including MS Office applications
- In depth technical and/or therapeutic expertise and knowledge of study, project and drug development processes
- Knowledge of project financial tracking and accounting methods and skill in applying them
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- May require occasional travel.
Quintiles Transnational has plenty to CRO about. One of the world's top contract research organizations (CROs), it...