Director, Head of Medical Operations

The organisation

The organisation is a Belgian Biotech company and currently looking for a Medical Director. This organisation is dedicated to transforming women’s health by offering new choices through innovation, with a particular focus on contraception and menopause. Their goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. 

The position

This is how you will make the difference
The organisation’s three lead development candidates are built on the organisation’s unique native estrogen platform. They also develop and manufacture complex therapeutics in contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing of its technological platform. The company is active in more than 80 countries around the world and currently employs approximately 300 staff members and is headquartered in Liège, Belgium.

Tasks & responsibilities

As the Head of Medical Operations, you will be the key strategic medical lead together with your peer Medical Ops Director where you will focus on both pre-and post-marketing activities. Furthermore, you are responsible for the organisation’s medical aspect of the clinical research activities in order to carry out the various research programs. In addition, you will be end-responsible for all the scientific communication related to these research programs and be the key contact towards key medical experts. Providing medical support to projects and participate actively in the development of the Target Product Profile (TPP) and Clinical Development Plan as well as providing medical support to PV and the Medical Information Department will be something you will work on, together with your team. Next to these primary objectives, the following activities will fall under your responsibility;

• Participate in meetings with Regulatory Agencies for input on medical aspects on for ?instance how to run the programs, guidance review on f.e osteoporosis etc. (FDA, EMA, etc.)
• Review statistical analytical plan
• Actively participate in the preparation and review of essential documents related to clinical ?studies (synopsis, protocol) and review and approve these documents as a medical officer
• Coordinate and actively participate in writing scientific publications and presentations
• Provide a medical review of the clinical study report
• Ensure a follow up and a review of the medical activities related to the realisation of the ?clinical studies (review of SAE’s, answers to questions CFR the protocol, amendments)
• Review and Ensure the update of the investigator’s brochure (IB)
• Driving KOL medical dialogue at national symposia and congresses
• Give presentations in advisory boards and writing positioning of the company

Candidate profile

What you bring
Given the seniority of the position we expect you to be an expert in this kind of roles. Therefore, we summed up the following requirements in order to fulfil the position:

• 8-10 years of experience in a medical related position on a (senior) management level
• Medical Doctor (MD)
• Scientific background with a strong preference for endocrinology and/or gynaecology or related. Any other scientific background can be considered if compensated with strong clinical development experience
• Advanced knowledge and clinical training in a medical/scientific area and experienced and known with leading complex clinical trials, ideally phase 3
• Working knowledge of GCP, clinical trial design, statistics, regulatory and clinical development processes
• Proven ability to work independently or in a cross-functional team setting ?
• Strong team player, encouraging cross-functional functioning with a proven track record in managing people in a matrix organisation?
• Strong scientific acumen combined with commercial sense, conviction and collaborative influencing skills and the ability to develop a strong scientific network
• Communication skills in at least English, both in written and spoken. French is considered as a plus

The offer

What's in it for you
The organisation is able to offer you the following

• An annual base salary between €150,000 and €200,000 based on full time with fringe benefits and flexible working hours
• A full time position within a dynamic and growing company
• Varied and motivating responsibilities within a fast growing company
• Dynamic team and have a position with autonomy and responsibility with opportunities to take initiatives to support further growth

Interested?

You can apply to this position by using the link below. For more information please contact Aron Berhane, +31 6 30 30 69 82.