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Director, Clinical Trial Execution - Start-Up Solutions Lead (all genders)

A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

Your role: 

In this exciting role you will collaborate with internal and external business partners in the development of the Country & Site Activation Strategy Plan for our clinical trials across Phase I-IV. The role is accountable and performs regular review of start-up performance and quality metrics at portfolio level and identify trends/gaps within the start-up processes, which may impact key deliverables and work closely with internal stakeholders and/or external partners to ensure action or mitigation plans are defined and implemented at a portfolio or program level. The role identifies and solves substantially complex or operationally important issues/problems, of high risk, impact or reach, in collaboration with internal or external business partners. In addition, you serve as the point of escalation to study teams for start-up process issues and facilitate resolution to issues identified. You will be accountable for raising awareness of such trends/issues in overall feasibility and start-up processes and facilitate solutions, working closely with relevant internal partners and/or external business partners, to ensure CAPA are defined and implemented. You take the lead and be the business process owner in the area of Feasibility, Site Selection and Site Activation process.

 

Who you are:

  • Medical or Life Sciences degree, or equivalent qualification, with Advanced degree desirable (MPH, MS, MA, MBA, PharmD); PM certification (CPM, PMP) desirable.
  • At least 15 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment
  • Understanding of the overall clinical development paradigm, especially in the area of clinical study operations and with global or regional experience.
  • Experience in oversight of external service providers
  • Thorough knowledge of ICH-GCP and applicable laws and regulations
  • Experience in multiple Therapeutic Areas, especially in oncology and immuno-oncology.
  • Previous supervisory experience
  • Familiar in process improvement framework and quality management tools.
  • Ability to work independently on assigned tasks or projects of increasing complexity and/or sensitivity.   
  • Extensive clinical knowledge and experience in clinical development/ operations with the capacity to oversee study planning and set-up activities.
  • Strong communication skills -verbal, written and listening, both in native language and English
  • Have Project Management, Critical thinking and proactive mindset
  • Fail fast and data driven mentality as well as agile methodology
  • Strong data insights and analytical skills to identify trends and drive quality / process improvements.
  • Excellent interpersonal skills to influence people and drive change
  • Adapt well to changes in assignment and priorties; adapts behavior or work methos in response to new information, changing conditions or unexpected obstacles.
  • Ability to balance competing priorities of various stakeholders and strive for achieving mutually beneficial and compliant solutions.  
  • Records of successful vendor mangement and interactions
  • Ability to make risk-based decisions based on a robust benefit/risk assessment. 
  • May require occasional business travel (domestic or international) 

 

 

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

Job Requisition ID:  217798
Location:  Darmstadt
Career Level:  E - Professional (10+ years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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