Project Manager

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 with CMC 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 with Manufacturing and R&D teams to track production campaigns, process validation, batch release, and API/finished product facility inspections;

Provide regular status 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 industry; 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 work effectively 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.

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 in accordance with Art. 13 of the EU General Data Protection Regulation (GDPR) 2016/679.

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