Medical Director Clinical Operations

About the position

This is a unique opportunity to be a major contributor to the success of a dynamic and growth stage biotechnology company. As InDex is about to start their phase III program with cobitolimod in moderate to severe ulcerative colitis, they are expanding their organisation with a new position as;

Medical Director Clinical Operations

The Medial Director Clin Ops will have the overall medical responsibility in the global phase III program. He/she will ensure an appropriate and continuous medical risk/benefit assessment at all stages to secure a sound and ethical development of a safe drug product. He/she will contribute to establish collaborative relationships with the investigators to ensure an efficient and timely execution of the program. As a speaking partner he/she will provide information about cobitolimod through visits to the clinics and virtual meetings.

The Medical Director will provide medical and clinical development input into the clinical programme from the clinical/scientific and strategic perspective. He/she will also contribute writing and reviewing of clinical key documents such as CDP, IB, protocols, reports and clinical parts of the TPP and IMPD. The Medical Director will provide his/her expertise in the evaluation and dissemination of data generated in the clinical trials.

 

About you

We are primarily looking for an experienced medical doctor, having a strong background in clinical operations. We are also welcoming applicants with a medical advisor background, a medical doctor degree and preferably experience from gastroenterology or immunology, and solid experience in clinical trials.

Mandatory

  • Medical Doctor / Physician with a PhD
  • Experience from the pharmaceutical industry, extensively involved in clinical trials

 

Preferred (but not must)

  • Medical expertise in gastroenterology and/or immunology
  • Proven track record of working in start-ups or in small biotech companies, not only big pharma
  • Experience in clinical phases of drug development from early phases to commercialisation

 

Personal Attributes

  • Self going, creative and solution oriented person
  • Open to work in an entrepreneurial and growing organization, where ownership, collaboration and own drive is of greatest importance
  • Hands-on approach as well as strategic capability
  • Ability and willingness to international travelling

 

Languages

Must be excellent in English, orally and written skills

 

For more information and to apply, welcome to contact our recruitment partner, Moveup Consulting AB. Send your CV and Cover letter to Daniel Kremer at daniel.kremer@moveup.se

 

By submitting your application, you also consent to us storing your personal data, including CV & cover letter and that we have the right to share this information with third parties (our client). You can revoke the consent whenever you want.

 

InDex Pharmaceuticals is a Swedish pharmaceutical company seeking to improve the lives of patients suffering from immunological diseases. Our mission is to develop effective and safe drugs for diseases with a significant medical need.

The company’s lead asset is the drug candidate cobitolimod, which is in late stage clinical development for the treatment of moderate to severe ulcerative colitis – a debilitating, chronic inflammation of the large intestine. Despite the currently available drugs on the market, many patients with ulcerative colitis still suffer from severe symptoms, and current therapies can cause serious side effects

Cobitolimod has a new type of mechanism of action. It is a so-called Toll-like receptor 9 (TLR9) agonist that can provide an anti-inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis. InDex’s clinical studies have shown that cobitolimod has a competitive efficacy and a more favorable safety profile than what has been reported for the currently approved biological drugs. Given the outstanding combination of efficacy and safety, InDex is now advancing cobitolimod into phase III, which is the final stage of development before application for market approval.

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