Regulatory affairs specialist Jobs in Köln

Clinical Outsourcing Director – Drug Development Programs

Germany - Remote Based

We are seeking a  Clinical Outsourcing Director  to join our fast-paced and mission-driven team. In this strategic leadership role, you will oversee all sourcing activities across assigned drug development programs. You’ll be responsible for vendor strategy, selection, contracting, and performance oversight, ensuring that external partnerships support program objectives and align with quality, compliance, and cost standards.

Key Responsibilities

• Program Leadership :  Lead and manage sourcing team members supporting assigned development programs. Collaborate cross-functionally to contribute to program planning and budgeting, while ensuring alignment of sourcing needs with overall program goals.
• Vendor Strategy & Management :   Align program-specific outsourcing needs with broader sourcing strategies and pre-qualified vendor networks. Serve as the escalation point for vendor-related matters in collaboration with Vendor Alliance Management.
• Vendor Selection & Contracting :   Drive end-to-end vendor selection processes, from RFP development to proposal review and decision-making. Lead contract negotiations in close collaboration with legal and finance teams, ensuring full coverage of program needs and protection of company interests.
• Change & Performance Management :  Oversee change order processes and ensure timely implementation. Monitor contract performance and metrics, manage documentation, and ensure program needs are continuously met.
• Process Optimization & Compliance :   Lead improvements in outsourcing processes, tools, and templates. Ensure inspection-readiness and adherence to industry standards and regulatory requirements.
• Market Insight & Innovation :   Stay informed on outsourcing trends, vendor capabilities, and regulatory changes. Bring forward best practices and innovative approaches to outsourcing strategy.

About You

You are a strategic and collaborative outsourcing leader with a deep understanding of clinical development. You thrive on building strong partnerships, navigating complex negotiations, and delivering operational excellence through smart sourcing solutions.

Your Profile

About Planet Pharma :

Planet Pharma is an American parented Employment Business / Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including : Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion / belief, sexual orientation or age.

www.planet-pharma.com