Descrizione:
The Interim Management Division of Randstad Professional, specialized in the search and selection of Middle & Senior Management profiles, is looking for on behalf of a leading corporation one professional profile of:
INTERIM PROJECT MANAGER, R&D Pharmaceutical Development
Reporting directly to the Chief Scientific Officer (CSO), the successful candidate will be responsible for managing and supervising the following activities:
- Provide comprehensive leadership, oversight, and execution support for a late-stage pharmaceutical development program entering FDA and EMA registration
- Define project scope, goals, deliverables, detailed project plans, schedules, budgets, and tracking tools;
- Manage project scope, risk, resources, budgets, and deliverables across multiple functions, monitoring progress and adjusting plans accordingly;
- Serve as the common point of contact linking internal and external scientific, operational, regulatory, and quality functions;
- Facilitate structured team meetings with clear agendas, action items, decision logs, and documented follow-up;
- Track progress of clinical operations activities (e.G., statistical analyses, CSR preparation) and review cycles for clinical documents (protocols, CSRs, SAPs);
- Collaborate with the Nonclinical team to manage timelines for study reports and the integration of data into Module 4 for the submission dossier;
- Coordinate withCMC and Analytical Development teams to track progress of formulation development, analytical method validation, stability programs, and Module 3 deliverables;
- Collaborate with Regulatory Affairs and external CRO(s) to track submission plans, regulatory strategies, briefing documents, and the compilation of Modules 1–5;
- Coordinate withManufacturing and R&D teams to track production campaigns, process validation, batch release, and API/finished product facility inspections;
- Provide regularstatus updates, issue summaries, and materials for executive reviews, senior leadership, and Board-level updates.
Ideal Profile
- Bachelor’s degree in Pharmacy, Pharmaceutical Chemistry and Technology, Chemistry, Biology, Biochemistry, or related disciplines (MS, PharmD, PhD, or MBA preferred);
- More than 5 years of project management experience in the pharmaceutical/biotech indu
- stry;
Solid knowledge of GxP, ICH guidelines, and drug development pathways;
- Direct experience with registration-phase programs and FDA/EMA submissions (NDA/MAA) is highly preferred;
- Demonstrated ability to manage cross-functional teams, complex timelines, and global teams/CROs (PMP or equivalent certification is a plus);
- Strong leadership, facilitation, organizational, analytical, and problem-solving capabilities;
- Ability to workeffectively in a dynamic, fast-paced, high-growth environment;
- Fluent English communication skills, both written and oral.
Please note that this role is offered on a freelance/contract basis, and candidates must hold a valid VAT number.
Location: Milan
This job posting is open to female (F), male (M), and non-binary (NB) candidates, in compliance with Italian Law no. 300/1970, Legislative Decree no. 198/2006, and Legislative Decree no. 96/2026. We welcome applications from everyone, fully embracing diversity and inclusion. Please read the Randstad privacy policy (https://www.Randstad.It/privacy/) in accordance with Art. 13 of the EU General Data Protection Regulation (GDPR) 2016/679.