Pharmacogenomics Clinical Program Manager, Clinical Operations
* Provide leadership and expertise in the execution of the global clinical operations Pharmacogenomic strategy with specific focus on directing global project teams to support the Pharmacogenomic component of all Phase 1-4 studies, as defined in the Integrated Development Plan. This responsibility will be for all compounds across all therapeutic areas ensuring all Pharmacogenomic procedures are executed in accordance with the Code of Federal Regulations, Good Clinical Practices, ICH Guidelines, and all applicable local regulations
* Takes a lead role in the education and support of the collection and management of subject samples for use in Pharmacogenomic studies working in close collaboration with Clinical Operations staff in all regions to ensure consistent adoption of best practice across all therapeutic areas.
* Responsible for the direct management of Pharmacogenomics Operations
* Defines, in conjunction with the Global TA Operational Leads, the Pharmacogenomic operational strategy for all therapeutic areas
* Responsible for directing global teams across all therapeutic areas to ensure operational implementation of the compound specific Pharmacogenomic strategy
* Make or recommend operational strategies/decisions to ensure all pharmacogenomic components within a program are delivered on time, on budget and to the required standards
* Provide expert Pharmacogenomic operational and strategic input into Clinical Study Plans, synopses, protocols and clinical study reports
* Anticipate and identify operational risks associated with Pharmacogenomic sample collection and management that may impact quality, timelines or budget and ensure contingency plans are in place
* Identifies and addresses all Pharmacogenomic operational issues with Global Clinical Program Managers serving as the main point of contact for all regional/global Pharmacogenomic issues
* Oversees all resource and finance forecasting (including due diligence) and oversees budget management for program pharmacogenomic budgets across all therapeutic areas
* Oversight of Pharmacogenomic Laboratory(s) selection and budget/ contract negotiation.
* Communication of Pharmacogenomic program related status, cost and issues to ensure timely decision-making by senior management
* Ensure adequate internal and external resources are available for the successful delivery of the pharmacogenomic content of all programs across all therapeutic areas
* Serves as the main point of contact for Pharmacogenomic regional and/or global issues
* Responsible for ensuring Clinical Operational global or regional alignment on pharmacogenomic related issues.
* Will lead or participate on Clinical Operations initiatives to develop innovative processes and technologies to advance Pharmacogenomic operations and reduce costs
* Develop operational processes to support pharmacogenomic study activities, including the development of and updates to SOPs that govern operational activity.
* Responsible for performance management of staff, define performance metrics, assessment of training needs, coaching and mentoring in support of performance management.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Education amp; Experience
* Bachelors Degree required, life sciences preferred. Advanced degree preferred.
* 7+ years of clinical development or trial experience in pharmaceutical industry and/or CRO required.
* 4+ years clinical trial management experience in any of Phases I through IV required.
* Phase II/III experience preferred.
* Experience managing multiple studies or global/international studies preferred.
* Track record of delivering clinical trials to time, quality standards and budget
Knowledge amp; Skills
* Expertise in Good Clinical Practices, ICH Guidelines and appropriate regulations
* Strong project management skills
* Excellent teamwork skills
* Excellent organizational skills
* Excellent interpersonal skills; good negotiation and influencing skills
* Good interpersonal skills; good negotiation and influencing skills
* Good analytical and problem-solving skills
* Strong written and verbal communication skills
* Enthusiasm for innovative research and ability and desire to lean new approaches and expand core skill set
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Ability to sit and stand for long periods of time.
* Carrying, handling and reaching for objects.
* Ability to lift and carry over 25 pounds.
* Manual dexterity to operate office equipment i.e. computers, phones, etc.
* Access to transportation to attend various meetings held in proximity to the Takeda offices.
* Some international travel will be required.
* Willingness to travel to various meetings or sites, including overnight trips. Some international travel may be required.
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