Director for Clinical Reporting

Are you passionate about leadership and bringing out the best in other people? Do you have an innovative mindset that drives change in a fast-changing environment? Do you like working with engaged and competent colleagues?

If yes, this opportunity of becoming Director for Clinical Reporting in Global Data Science could be the right next step in your career!

The position
You will as Director for Clinical Reporting lead the team of 7 dedicated employees and be overall responsible for the global medical writing and clinical reporting function. Further the role takes seat in the Clinical Data Science management team and is responsible for ensuring the fulfilment of Global Clinical Reporting commitments as well as contributing to a positive working environment, including high employee satisfaction. A key task of the role is to take leadership of the team, ensure alignment with key stakeholders and provide optimal allocation of resources to projects and tasks, while coaching and developing employees toward successful task execution.

Your responsibility and assignments will cover:

• Management of the Clinical Reporting team including responsibility for resourcing projects and tasks to fulfil medical writing and clinical disclosure commitments and deliverables.
• To be responsible for the employee’s goal setting, professional development, and training plans.
• Coordinate activities with Global Clinical Development, Global Regulatory Affairs, Safety and Pharmacovigilance, Global Medical Affairs, and affiliate companies as appropriate.
• To ensure that the approved Clinical Development Plans and Regulatory Submission Plans are assigned to the teams and employees in the department and plans are executed according to timelines.
• Coordinate and ensure global public disclosure activities for trials in ALK according to requirements.
• Participate in publication planning activities and support development of publication plans.

Your profile
We expect that you have:

• A relevant educational background as MSc or PhD.
• Broad experience within medical writing (min. 8 years).
• Proven experience in people management, with the ability to inspire, mentor, and develop your team.
• Thorough knowledge and experience with regulatory interactions (e.g. EMA, US FDA, CA HC, CN CDE or JP PMDA).
• Knowledge about clinical disclosure requirements.
• Developed collaboration and stakeholder management skills.
• Fluency in spoken and written English and exceptional communication and writing skills.
• Experienced IT-user skills.

Become a part of ALK
ALK is a global pharmaceutical company specialised in allergy immunotherapy. We provide an attractive working environment for individuals looking for both personal and professional development. 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 18 September 2024.

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 don't 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 www.alk.net. For further information regarding the position please contact Senior Director, David Mollerup on +45 61 91 10 81.

We are looking forward to hearing from you!