In collaboration with other Research and Development departments and applicable Business Unit partners,
•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:
Key Skills & Competencies:
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