Linkedprime
Dompé

Clinical Development Execution Excellence - R&D Development Specialist

Posted: 11 hours ago

Job Description

At Dompé, we are not just a pharmaceutical company, we are an innovation-driven organization with over 130 years of experience, committed to advancing science and improving human health.For our office in Tirana, we are seeking a highly organized Clinical Development Execution Excellence - R&D Specialist. The Specialist, Clinical Development Execution Excellence (CDEE) supports the operational execution of clinical development activities by managing external engagements, contracts, and fiscal processes.Responsibilities:This role ensures compliance with internal policies and external regulations, facilitates vendor and HCP contracting, and contributes to process optimization across R&D Development.This position will directly report to the Analyst of CDEE and collaborate closely with cross-functional teams/functional leaders to enable external evaluations (e.g. RFIs and RFPs), contracting (e.g. CDAs/NDAs, MSAs, SOWs, CTAs, etc.) and fiscal management (POs, accruals, and budget tracking) to support clinical development objectives/activities for R&D Development.Provide lifecycle management for a large volume of contracts supporting Dompe’s R&D organization, to include drafting, negotiation, execution, applicable amendments, and closeout.Ensure timely processing and alignment with internal compliance and legal standards.Maintain centralized tracking of contract status and proactively flag delays.Act as liaison with external vendors, consultants, and HCPs throughout the engagement lifecycle.Support/build effective partnerships with R&D functions/leadership, quality, legal, procurement, finance, and other departments as appropriate to ensure that outsourcing, contracting, and fiscal management needs are met and handled in an optimal and efficient manner.Maintain proactive communication with stakeholders to resolve issues and align priorities.Manage Purchase Order (PO) processes, tracking and reconciliation.Support Invoice approvals and accrual reporting in collaboration between Finance and Controlling.Identify and escalate discrepancies or delays in payment processing and support fiscal reporting/invoice approvals, in collaboration with the controlling department, and collaborate with business agreement managers (BAMs), Finance, and vendors etc.Provide support in cases where contractual and/or PO amendment is needed.May support project financial/accrual data capture activities.Support/lead the establishment and refinement of departmental workload tracking and reporting functionality and processes.May include the creation of routine and specialized reports such as metrics tracking, data visualizations, and summary reports for stakeholders, including senior management.Develop and maintain dashboards and reporting tools to monitor departmental workload, contract status, and vendor performance.Generate routine and ad hoc reports for senior management to support decision-making.Assist/lead in the evaluation, selection, outsourcing and management of various vendors/consultants.Establish and maintain direct third-party contacts including acting as the ongoing interface with vendors regarding contractual issues during the lifetime of a project.May support vendor and alliance partner relationships.Contribute to the development of an established preferred vendor list.May serve on preferred vendor and alliance partner committees and/or governances as needed.Support ongoing process improvement initiatives across CDEE and R&D Development.May author and/or review SOPs and other controlled documents.May develop/enhance related training materials.Perform other duties as may be assigned from time to time. Qualifications:BS/BA in Life Sciences/Business/Finance or related field, or equivalent industry experience. Required Skills:Minimum of 2-4 years of related experience, preferably within pharmaceutical R&D or broader healthcare industry.Excellent communication, interpersonal, organizational, and writing skills.Sound judgment, strong work ethic, and commitment to ethical and compliant behavior, especially in interactions with HCPs/HCOs and external partners.Ability to work independently and to be reliable, responsive and accountable.Solutions-oriented team player with a commitment to client satisfaction and operational excellence.Ability to work effectively in a collaborative team environment and manage multiple projects simultaneously.Ability to devise innovative approaches, tools, methods and systems to increase operational efficiencies. A wide degree of creativity and autonomy is expected.Excellent software and computer skills. Proficient with MS Office applications.

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