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Herakles Pharma

Clinical Project Director

Functiegroep: Clinical Operations
Werkweek:40 uur
Procedure: W&S
Vacature ID:#755

Clinical Project Director

De organisatie

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 (<5%) and high repeat business rate (>90%).

One of the things that distinguish CR2O is its focus on quality and efficiency, at the best price available on the market. We believe in using highly qualified, independent professionals to make the difference in the process of realising your 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.

De functie

Due to growth of activities CR2O is seeking an experienced Clinical Project Director 0.8 – 1.0 FTE.

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. This includes 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 may also include 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 other CPMs working within the program. The Sr CPM will also be responsible for grant application management including the development of grant applications (i.e. Horizon2020 or CEPI programs). The Sr CPM 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.

Het profiel

The ideal candidate for the function as a Clinical Project Director will offer:

  • Bachelor’s required, Master’s preferred;
  • A minimum of 15 years of clinical operations experience, with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device and/or CRO industry is required;
  • Five or more years of clinical program management experience at a sponsor or CRO company;
  • Prior monitoring and clinical project management experience is required;
  • Extensive experience with vaccine development;
  • Experience with oncology clinical studies (preferred);
  • Experience in development of grant applications and grant management (preferred).

Knowledge, Skills and Abilities:

  • Read, write and speak fluent English; excellent verbal and written communication skills;
  • Must have a thorough knowledge of clinical research concepts, practices; EMA/FDA regulations and ICH Guidelines regarding drug development phases; clinical research and data management methods;
  • 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 program 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 interpersonal skills: Proactive, innovative, good planning skill.

Het aanbod

CR2O offers an unique position within a growing company, an enthusiastic and flexible working environment. Located in Maarssen, central located with lots of parking space. Flexible working hours and possibilities to work from home. We offer a competitive benefit package (lease car, 36 vacation days etc).

Inlichtingen bij

Interested in this position as a Clinical Project Director? Contact Leonie Koomen via / +31 6 1051 83 23.