Project Director, Dermatology & Rheumatology CRO, Germany

Overview

The Project Director is responsible for oversight of the conduct of a program or portfolio of clinical studies or large global multi‑centered trials with large study budgets. The portfolio may comprise studies for specific customers, and/or a group of studies within the same therapeutic area or indication for more than one customer. The Project Director oversees Project Managers (PMs) who are managing projects ranging in size and complexity from single service studies to large full‑scope, multiple protocol projects, global projects and/or portfolio of projects. The Project Director leads the operational contribution to proposal development and business development activities at a project level with minimal oversight directly applying their therapeutic and project management expertise.

Responsibilities

• Oversee a portfolio or program of projects and the Project Managers assigned to operationalize the awarded studies.
• Ensure all studies within a program or portfolio are conducted to reflect the therapeutic or client‑specific requirements.
• Represent the company to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively.
• Ensure the study is progressing according to internal and customer quality standards, SOPs, GCPs or appropriate regulatory requirements, and ICH guidelines to fulfil all federal and local regulations.
• Oversee the management of the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses.
• Maintain and evaluate project progress by maintaining timelines and other tracking/analysis tools.
• Ensure and maintain an in‑depth therapeutic and/or client‑specific knowledge and expertise for the assigned portfolio.
• Apply study‑specific learning across assigned portfolio of studies/clients.
• Lead and ensure consistency in contingency planning and risk mitigation strategies to ensure successful delivery.
• May lead operational input to proposal development and pricing, including proposed operations strategy.
• Drive performance improvement, operational efficiencies and innovative strategies.
• May provide line‑management oversight and contribute to leadership of Project Management as an operational and therapeutic area expert.

Requirements

Education

• Bachelor of Science in a relevant discipline.
• A master’s degree is an asset.
• PMP or PRINCE2 certification is an asset.

Experience

• At least 15 years of industry experience and a minimum of 5 years at a CRO.
• At least 10 years of clinical project management experience, including management of all project phases from start‑up to closure, management of all functional services, and vendor management. Experience with mid‑size and large studies (>10–15 countries) in multiple regions (NA, SA, APAC, MENA, Europe) is desirable.
• Experience leading concurrent multi‑centered, multinational phase III clinical trials including project budget financial tracking and forecasting.
• Substantial experience in project supervision, mentoring and coaching of project managers.
• Substantial experience with business development tasks, such as development of proposals, client presentations, bid defense meetings, and the like.
• Dermatology or rheumatology experience is required.

Knowledge and Skills

• Good knowledge of GCP, and applicable Health Canada and FDA regulations/guidelines.

Location and Travel

This opening is for a home‑based position in Germany. Regular travel, which may include overnight trips and/or international travel, is required as part of this role.

Equal Opportunity Statement

Indero is committed to providing equitable treatment and equal opportunity to all individuals. Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Germany.