The company assists in product development by building up essential know-how in the field of gastrointestinal transit, bioavailability, metabolism, immune modulation and efficacy of food compounds, functional ingredients and pharmaceuticals, in relation to their fate and function in the body. They are long-standing experts in the study and modeling of gastrointestinal processes.
The company is looking for a (associate) director to join its R&D team in Ghent, Belgium, and support the Early Development (Ph1 and Ph2) of its clinical candidates in the field of Live Biotherapeutic Products for a range of indications in the area of gastroenterology.
Responsibilities will include but are not limited to
• Guiding clinical trials on new pharmaceuticals and therapeutic approaches and overseeing the general management of external consultants and CROs.
• Determining goals and objectives for designated product development strategies and assuring operational alignment with senior management priorities.
• Collaborating with the CMO and the Development Team Lead to achieve the delivery of the clinical objectives while optimizing speed, quality and cost.
• Planning, directing, and evaluating all clinical activities within the development portfolio of the company, including study planning and oversight, medical writing, creating budget plans, drafting contingency plans, quality assurance, maintaining recruitment and retention strategy plan, tracking resource utilization, arranging work schedules and liaising with doctors, consultants or investigators.
• Translating the clinical approach into an integrated study management plan/project management plan, including project delivery strategies for Request for Proposals (RFPs) and preparing and leading bid defenses with CROs and Vendors and subsequent CRO oversight.
• Preparing Investigator meetings, providing oversight on Site management, Clinical Supplies and Clinical Monitoring; guiding of CRAs to assure compliance with the clinical trial protocol and advising on critical study issues.
• Monitoring of clinical progress against preset timelines and deliverables and preparing/ presenting project information proactively to all stakeholders internally and externally as required.
• Delivering the project/program according to the quality management plan. Achieving project quality by identifying quality risks and issues, responding to issues which impact the clinical delivery, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans.
• Managing risks which could impact on the clinical delivery of the project and determining contingencies.
• Collaborating with other functional groups within the company or externally where necessary to support milestone achievement and to manage study issues and obstacles.
• Deep understanding of Clinical Research practices and broad therapeutic knowledge
• In depth knowledge of, and skill in applying relevant clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Strong knowledge of Project management practices, incl. resource management and financial accounting
• Ability to identify and organize clinical resources needed to accomplish tasks, set objectives and provide clear direction to others; experience in planning activities in advance and taking account of possible changing circumstances
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback; experience in cross-functional partnering to advance work effectively and efficiently
• Excellent CRO and Vendor management skills and demonstrated ability to have effective conversations with internal/external stakeholders, negotiate solutions and understand broader impact beyond immediate project on the overall program/portfolio and company strategy
• Proven ability at analyzing data and information to derive conclusions and drive sound decision making
• Strong understanding of other company functions and their inter-relationship to achieve project delivery
• Experience working productively in a pressurized environment, managing competing priorities and maintaining a positive outlook at work
• Excellent communication and presentation skills, including good command of English language
• Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving
Minimum required education and experience:
• Master's or higher level degree in a health care or other scientific discipline or educational equivalent
• A minimum of 6 years of clinical trials or clinical project management experience, including 2 years experience in a leadership capacity; or equivalent combination of education, training and experience.