Medical Director, Ciraparantag

vor 4 Stunden

Zug, Schweiz Covis Pharma Vollzeit

You may be based remotely in the U.S. or at our Zug, Switzerland office location for this role. You may also be office based at our Waltham, MA, Berkley Heights, NJ or King of Prussia locations. If remote in the U.S., we prefer you live in the Eastern or Central Time Zone.

We are currently searching for a **Medical Director **to be responsible for contributing to the clinical development planning, the writing of clinical protocols and overseeing the safety monitoring and evaluation of upcoming phase III clinical trials for Ciraparantag.
**What is Ciraparantag?**

Anticoagulants have been approved for indications such as prevention of stroke in patients with nonvalvular atrial fibrillation, prevention and treatment of deep vein thrombosis and pulmonary embolism, and reduction in the risk of myocardial infarction or other cardiovascular events in certain patients. More recently, direct acting oral anticoagulants (DOACs) have been developed that have several advantages over traditional therapies, including rapid therapeutic effectiveness, ease of dosing, and lack of monitoring requirements. However, despite the advantages of DOACs, all anticoagulants are associated with some risk of major bleeding.

Across the various indications of the currently available anticoagulant medications, the risk of major bleeding typically ranges from 1% to 5% annually, although individual patient risk can vary substantially based on numerous factors including age, co-morbidities, and concomitant medications. A major concern regarding the use of any anticoagulant, including the DOACs, is how to manage this risk of major bleeding in patents on therapy. The availability of an anticoagulant reversal agent that is safe, effective and convenient to use may be critical in patients with serious/life-threating bleeding, prior to urgent or emergency surgery, after major trauma, or in cases of anticoagulant overdose.

Ciraparantag is a small, synthetic, water-soluble molecule that physically associates with heparins and DOACs with the goal of reversing the anticoagulant effects of these agents. This is mediated through direct hydrogen bonding and/or ionic, non-covalent attachment to the anticoagulant molecule. Ciraparantag has been developed as an intravenous (IV) formulation and is expected to be administered as a single IV dose infused over approximately 10 minutes. Covis is developing Ciraparantag for reversal of anticoagulation in the setting of acute major bleeding, and prior to urgent surgery/procedures when reversal of anticoagulation is required.
**Company Overview**

Founded in 2011, Covis Pharma is a private equity backed global specialty pharmaceutical company that markets therapeutic solutions in 50+ countries, for patients with life-threatening conditions and chronic illnesses. Our paramount concern is patient’s outcomes as we focus on improving the health of people with serious medical conditions. Apollo Global Management is the private equity sponsor of Covis Pharma.

If you are looking to be a part of a global, vibrant, and fast-growing organization, have a positive attitude, seeking career development and acceleration and are energized by being a part of improving the lives of the patient’s we serve, we are the perfect match for you.
**WHAT YOU CAN EXPECT TO DO IN THE ROLE**:
**FOR THIS ROLE YOU WILL NEED**:

- MD or the International equivalent.
- Previous Pharmaceutical/Biotech industry experience.
- Previous experience managing Phase 2 and 3 clinical trials and/or clinical development program(s) is preferred.
- We prefer a specialization or prior experience in the field of Hematology/Coagulation.
- Strong track record in drug development and demonstrated evidence of cross-functional integration with ability to successfully matriculate projects through development phases, collaboratively, in a challenging team matrix environment.
- Possess a comprehensive understanding of applicable US and EU regulatory requirements and of the drug development process to include prior experience in filing and defending US INDs and/or NDAs.
- Have a working knowledge of biostatistics, data management, clinical operations, and clinical pharmacokinetic scientific and technical processes.
- Collaborative and proactive, with a hands-on, roll-up-the sleeves style and attitude.
- Flexibility and ability to respond to rapidly changing environments and circumstances.
- Ability to influence decision making around multifaceted issues involving medical safety.
- Fluency in the English language mandatory, German and any other language is an advantage.
**OUR OFFER TO YOU**:
By joining Covis Pharma you will be a part of a dynamic and energized team w/ a vested interest in your personal and professional development. You will be able to provide input into impactful decisions and be a part of shaping our company’s future. The skills and business insight you gain will serve as an invaluable foundation toward developing your career with us. We offer o

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