Head of Clinical Affairs, Xbrane
Search4S Dustgoat AB / Övriga jobb / Solna
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hela Sverige Are you experienced in leading clinical programs within pharma? Do you wish to take the overall responsibility for the entire clinical program from idea to marketed products? Xbrane is starting the first clinical phase III studies for two products and is looking for the Head of Clinical Affairs.
As Head of Clinical Affairs you will have a key role and overall responsibility for all clinical activities at Xbrane. Preparations for the first clinical trials in phase III are initiated for the products Spherotide and Xlucane.
Responsibilities include:
• Development & maintenance of a clinical strategy for Xbranes products.
• Plan, design and initiate clinical studies & study protocols in collaboration with CRO:s and consultants. Contract management for CRO:s.
• Communication with relevant authorities. Prepare & participate in scientific advice.
• Ensure compliance with relevant regulations for different markets, e.g Europe, USA and Asia, for clinical trials in all stages.
Xbrane have six more products in the pipeline that are in earlier phases of clinical development. As Head of Clinical Affairs you manage the entire portfolio from a clinical perspective, from pre-clinical stages to post-market.
Xbrane is an innovative company with in-house research and development. You will have a key role in the transition from start-up to an established pharmaceutical company.
Terms: The position is open-ended, starting upon agreement.
Location: Xbrane headquarters in Solna
To manage the clinical program we believe that you have:
• extensive experience from leading clinical studies within pharma as e.g. clinicial research manager, project manager or similar
• been responsible for the contract with CRO for clinical studies, alternatively in the corresponding position at a CRO.
• developed & maintained clinical strategies
• maintained contact with relevant authorities and participated in scientific advice
• prepared study protocols
• High proficiency in English is required. Knowledge in Swedish is meriting.
• Experience from working with clinical development at a relevant authority is meriting.
In addition to you knowledge and experience you have the ability to lead & communicate all activities related to clinical trials at Xbrane. You are independent, get things done and have the perseverance to achieve the goals.
Is this you? Welcome to contact us!
Xbrane is a biopharmaceutical company specialized in high demand biosimilars and long acting injectables. The segment has a high entry barrier, driven by high production complexity and the need of specific Know-How. Xbrane currently possess its own expertise within production of complex generics with slow release formulation and unique technologies for producing proteins efficiently.
Varaktighet, arbetstid
The employment is with Xbrane. It is not a Consultant assignment.
Publiceringsdatum2017-02-01Så ansöker duSista dag att ansöka är 2017-02-26
Ange följande referens när du ansöker: Xbrane Clinical
KontaktAnna Rennermalm
anna@search4s.se +46707942005
FöretagSearch4S Dustgoat AB
AdressSearch4S Dustgoat AB
Banvaktsvägen 22
17148 Solna
KontorsadressBanvaktsvägen 22
Jobbnummer 3294958
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