Our pioneering employees and personal approach lead to operational excellence, paving the way for new treatments with positive societal impact. With its head office in Maarssen, CR2O has extensive experience managing and implementing clinical trials in over 30 countries. To our customers, we are ‘just the right size’ CRO: we realise cost-effective study delivery locally or internationally within the defined regulatory framework, quality parameters, study timelines and budgets. We are a responsive, hands-on organisation with driven, enthusiastic staff, as evidenced by our very low employee turnover rate and high repeat business rate (>90%).
One of the things that distinguishes CR2O is its focus on quality and efficiency, at the best price available on the market. We believe in using highly qualified, responsible professionals, and actively support realisation of personal development goals. Our management is actively involved in all our clinical trial services and ensures that you receive the best support possible. This is in line with our business philosophy, which is based on customer satisfaction.
Due to growth of activities CR2O is seeking an experienced Director Clinical Programs 0.8 – 1.0 FTE.
About the Director Clinical Programs (DCP) position
In this role you will be accountable for developing the operational strategy and managing the timelines, budgets and quality of large or complex studies and/or clinical development programs. It includes organisation and management of the preclinical, regulatory, clinical and CMC trajectories and requires understanding and planning how different studies fit together (e.g. how the readout from a study informs the next steps and overall program strategy). It involves planning and oversight of strategic drug development partnerships and/or clinical research collaborations along with business development opportunities for the specific category and coordination of the clinical project managers working within the program. The Director Clinical Programs (DCP) provides cross-functional operational leadership and management including but not limited to: facilitating issue identification and resolution, problem-solving, risk management, contingency planning and decision-making.
The ideal candidate for the function as a Director Clinical Programs will offer:
- Master’s required, PhD’s preferred;
- A minimum of 15 years of clinical operations experience, with increasing levels of responsibility, in the Pharmaceutical and or Biotechnology industry;
- Two or more years of clinical program management experience;
- 5-10 years clinical project management experience;
- Extensive experience with drug development and clinical evidence strategy;
- Experience in clinical research (writing of product development plans, protocols, study reports);
- Experience with immunology/vaccinology clinical studies is preferred.
Knowledge, Skills and Abilities:
- Read, write, and speak English fluently; excellent verbal and written communication skills;
- Must have a thorough knowledge of clinical research concepts (methodology, study design, statistics);
- Must have knowledge of EMA/FDA regulations and ICH Guidelines regarding drug development phases;
- Must have prior experience managing a clinical trial portfolio or large-scale clinical trial program globally and be able to demonstrate a proven track record of successfully leading cross-functional projects in a global environment;
- Broad drug development experience: understands interplay/intricacies of drug development programs and understands how studies fit together and planning involved (sees the big picture);
- Broad project management experience;
- Strategic thinking and targeted problem-solving skills;
- Maintains scientific knowledge and expertise of indication/asset to possess credibility to discuss with higher level management;
- Strong intrapersonal skills: Proactive, innovative, good planning skills.
CR2O offers a unique position within a growing company, an enthusiastic and flexible working environment. Centrally located in Maarssen, with lots of parking space. Flexible working hours and possibilities to work from home. We offer a competitive benefit package (car allowance, 36 vacation days etc).
Interested in this position? Or curious for more information?
Please, contact Ellemieke von Mauw:
Ellemieke von Mauw
Director Clinical Programs | Business Development
T +31 (0)85 071 74 65 | M +31 (0)6 57 76 61 45 | E firstname.lastname@example.org