91 days ago on santhera.com

Senior Clinical Research Physician

Santhera Pharmaceuticals (Schweiz) AG

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 Please refer to JobSuchmaschine in your application

Senior Clinical Research Physician

Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty
pharmaceutical company focused on the development and
commercialization of innovative pharmaceutical products for the treatment
of orphan mitochondrial and neuromuscular diseases.
In September 2015, our leading product Raxone® (idebenone) received European Marketing Authorization
in the treatment of patients with LHON (Leber's Hereditary Optic Neuropathy). Raxone® is not only the first
and only medicine approved for this condition, but it is also the first medicine approved for any mitochondrial
disorder.
The company currently develops Raxone® in other areas of high unmet medical needs, like the treatment of
Duchenne Muscular Dystrophy (DMD) and Primary Progressive Multiple Sclerosis (PPMS). In addition,
Santhera’s pipeline includes omigapil, an investigational drug with anti-apoptotic properties, a compound in
development to address unmet medical needs for patients with Congenital Muscular Dystrophy (CMD).
For more information, please visit the company's website www.santhera.com

We are currently looking to hire a:

Senior Clinical Research Physician,
to be based at our Headquarters in Liestal, close to Basel.
Scope of Work
This is an outstanding and unique opportunity for an experienced drug development professional with a
®
range of skills and expertise suited to oversee and manage our Raxone (idebenone) ophthalmology
franchise. You will have a key role within an organisation that is highly committed to the development of
specialised medicine, ensuring collection of as many data as possible on the use of the new Santhera's
product.
The responsibilities for this role include the following
Provide clinical expertise in ophthalmology for internal (clinical operations, regulatory affairs,
pharmacovigilance and safety monitoring boards) and external (health authorities, ethics committees,
research oversight and funding committees, key opinion leaders, investigators and patients) stakeholder

requirements including:

 Interaction with investigators and key opinion leaders on clinical development and post-marketing
programs within Santhera’s idebenone ophthalmology franchise
 Training of internal and external personnel on ophthalmological aspects of ongoing programs
 Participation in key regulatory meetings globally, prepare documents and submissions, including
authoring clinical components of study reports, dossiers and presentations
 Contribution to the development of presentation materials for advisory boards, investigator meetings,
scientific congresses, company presentations etc.
 Support for medical affairs, including medical education and the establishment and maintenance of
contacts with investigators, key opinion leaders, patients and patient organizations
 Medical monitoring and interpretation of safety data in collaboration with pharmacovigilance and
internal and external safety monitoring boards
 Review of clinical trial data, providing expert analysis and interpretation and contribute to study
reports and publications
 The development of protocols, IBs and IMPDs, informed consent forms and other related documents
 Medical/scientific due diligence for in-licensing candidates and out-licensing of ongoing programs

As an ideal candidate for this role you should have/be
 MD with ophthalmological qualifications, expertise and experience
 Experience of successful drug development, with at least 3 years of clinical research experience in a
leadership role in a major pharmaceutical or contract research organization with a proven track
record
 Proven ability to interpret, discuss and present clinical data to critical audiences (neuro-
ophthalmologists and ophthalmologists)
 Sound understanding of medical information and medical marketing
 Fluent in both written and spoken English; fluency in additional languages would be advantageous
 Advanced medical writing and communication skills
 Proven ability to work independently and in a cross-functional team
 Can do attitude and entrepreneurial spirit
 Problem solver, individually and in working teams
 Proactive and detail oriented
 Orphan drug experience would be preferred

If you are interested please send your CV and motivation letter by email to: doina.mazilu@santhera.com

Strictly no agencies
Recruitment agencies are kindly invited to refrain from sending to Santhera unsolicited CVs.