In collaboration with other Research and Development departments and applicable Business Unit partners,
- Responsible for the strategic and operational oversight, management, and delivery of one or more clinical development programs in support of Shire’s development strategy.
- Authors, provides input, and/or oversees program and/or study level documents.
- Manages all internal and external team activities as outlined in the partnership manual with CRO or in contract with other vendors.
- Manages financial aspects of assigned clinical program(s) or study(ies).
- Responsible for strategic initiatives for process and business improvements within CDO
•Provides functional input into the clinical development plan that aligns with development team and product strategy.
•Collaborates with project physician, statistician and relevant functional areas on clinical trial designs.
•Provides strategic clinical programs input to Early-stage Global Product Team (EPT) / Late-stage Global Product Team (LPT).
•Co-leads the Clinical Sub-Team (CST) with the Global Clinical Development Lead (GCDL).
•Has a thorough understanding of the clinical trial(s) protocol(s) and is able to anticipate potential issues that may arise during the conduct of the trial in close collaboration with CROs
•May attend advisory panel meetings and regulatory agency meetings related to strategy of program, indication, and studies.
•Has in-depth knowledge of global regulatory/industry guidelines (e.g. ICH/GCP, promotional guidelines and labeling) to drive the clinical trial application process.
•Effectively represents the interests and perspectives of CDO.
•Presents program/study(ies) overviews/status to senior management, cross functional team, and external partners as necessary.
•Co-leads inspection readiness activities, and acts as subject matter expert during regulatory inspections.
•Acts as the main escalation point of contact for strategic CRO alliance partner(s) for the assigned program and the key stakeholder for clinical operations within the R&D organization
Oversees or is accountable for:
•Program and /or study level document generation (e.g., synopses, ICFs, submission modules).
•Vendor selection including critical review of contracts, and/or work orders and management of ongoing performance.
•Collaboration with internal functions to ensure successful implementation of program/study.
•Presentations at relevant internal and external meetings
•Conducting study level training.
•Alignment of program for cross-functional team regarding execution.
•Reporting of program / study milestones including mitigation.
•Works closely with Global Development Lead (GDL), finance business partner, and/or study team(s) to generate and review forecasts and accruals for clinical studies.
•Ensures clinical program/study(ies) finances align with agreed development plan, and budget variances are escalated to management as appropriate.
•May assess long-range resource needs and make recommendations and allocations across program(s).
•Mentors junior staff.
•May be involved in interviewing, hiring, and training employees.
•Provides feedback on employee performance.
•Promotes Clinical Programs achievements within and across department(s).
•Reviews and contributes to strategy for operational efficiency.
•Collaborates on SOP development and harmonization
•Identifies or participates in innovative initiatives targeted to improve/revise clinical development processes.
•Ensures implementation and standardized use of Clinical Development Operations (CDO) and/or other R&D tools.
Education & Experience Requirements:
- Bachelor’s degree is required. Scientific/health care field preferred but not required. Advanced degreepreferred.
- Significant clinical research experience (8+ years) with evidence of increasing responsibility within a pharmaceutical/biotech company or CRO
- Global clinical operations research experience is preferred
- Strong background in project management
- Experience leading cross-functional teams
- Detailed knowledge of current regulatory requirements and guidelines governing clinical research
- Participation in investigational new drug and marketing application review and submission is preferred.
- Experience managing financialbudgets is required.
Key Skills & Competencies:
- Must be able to participate in the design of drug development programs as well as create program and/or study level documents.
- Strong knowledge of applicable computer and project management software packages.
- Demonstrated ability to present information to Shire management, CROs and external audiences (as applicable).
- Ability to oversee and/or manage and communicate effectively with research vendors including negotiating contracts, reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints.
- Strong interpersonal skill set necessary to create and maintain external collaborator relationships (e.g. Key Opinion Leaders).
- Demonstrated ability to prioritize across program / study demands ensuring overall quality.
- Requires strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
- Ability to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
- Ability to work independently, take initiative and complete tasks to deadlines.
- Ability to work successfully within a cross-functional team.
- Demonstrated ability to motivate & mentor staff.
- Excellent written and oral communication skills.
- Displays a high level of professionalism with internal and external stakeholders.
- Develops project plan(s) to achieve long-term goals based on higher business level drivers and strategies.
- Demonstrated ability to create and manage program and/or study budgets including communication of overspend /underspend risk and mitigation efforts.
- Communicate with key internal and external stakeholders to ensure success and looks for opportunities for collaboration.
- Respectfully challenges current practices, decision or ideas to uphold quality or ethical standards.
- Proficiency with common office software programs, including Microsoft Word, Excel, Power Point, and Project
Other Job Components:
Complexity and Problem Solving
•Must be able to independently present complex program and/or study information to internal and external stakeholders.
•Proven ability to manage and communicate effectively with research vendors including negotiating contracts, reviewing requests for proposal, analyzing scopes of work, and responding to inquiries and complaints. Proven ability to independently resolve problems or to elevate in a timely manner.
Internal and External Contacts
This job reports to the Clinical Programs Team Lead and is functionally accountable to assigned Program Team leadership. Internal stakeholders include R&D functions and applicable business unit stake holders.
External stakeholders may include counterparts at clinical vendors, investigative sites, Key Opinion Leaders and other stakeholders as identified.
Available for up to 25% domestic and/or international travel.
Req ID: R0015824