Associate Director, Clinical Compliance & Processes
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Job Location:
Monthly Salary:
Posted on:
19 hours ago
Vacancies:
1 Vacancy
Job Summary
We are seeking a highly skilled and experienced colleague to lead our Clinical Compliance & Processes this role you will be responsible for maintaining compliance strategies ensuring adherence to international guidelines and regulations and supporting our clinical development functions.
The position
Your primary tasks will be:
- Lead the Clinical Compliance & Processes team.
- Develop maintain and take responsibility for compliance strategies and plans within GCD.
- Responsible for oversight and updates to the Quality Management System (QMS) and support quality document development.
- Ensure compliance oversight.
- Support internal audits Health Authority inspections and Notified Body audits.
Your profile
We expect that you have:
- Relevant educational background.
- Extensive knowledge and experience in clinical development.
- Experience with supporting audits and inspections
- Minimum of 10 years of relevant experience.
- Minimum 3 years of management experience is preferred.
- Fluency in spoken and written English.
- Strong oral and written communication skills.
Become a part of ALK
We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialised in allergy immunotherapy. We are driven by a high level of professionalism integrity an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be part of an engaged and informal team who values skill and knowledge creation. The result of your efforts will be significant throughout the organisation and you will be able to actively influence and challenge the status quo.
Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.
Apply
Apply by attaching your CV and a short letter of motivation no later than 1 December 2025.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Hence we prefer that you do not add images in your application documents. We evaluate applications and call for interviews on an ongoing basis so dont wait to apply! We reserve the right to take down the advert when we have found the right candidate.
Do you want to learn more about our company we encourage you to visit us at . For further information regarding the position please contact SeniorDirector David Mollerup onwho is available from the 24 November due to travelling.
We are looking forward to hearing from you!
Required Experience:
Director
Key Skills
- Program assessment
- FDA Regulations
- Manufacturing & Controls
- Program Evaluation
- budget forecast
- Research Experience
- Operations Management
- Research & Development
- Strategic Planning
- Contract Management
- Leadership Experience
- negotiation
