We are recruiting a VP Clinical Development and Strategy to Medivir. The company develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients.
The company was founded in 1988 and has been publicly listed since 1996 on Nasdaq Stockholm. Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership.
The company is currently focused on its internal clinical development program for liver cancer and has several international partnerships either in clinical development or which, if successful, could lead to FIH trials.
The company has developed two pharmaceutical products, Xerclear and Olysio, all the way from idea to market launch.
- Responsibility over all clinical development activities, from FIH to registration, both operationally and strategic.
- Ensure a well-functioning high-performing clinical study team.
- Lead and coordinate the development of clinical documentation.
- Lead, coordinate and align the regulatory strategy work together with external consultants.
- Responsible for the development and delivery of Clinical Development Plans for specified candidate drugs.
- Key contributor to QA and compliance documentation for Clinical R&D including input to the regular maintenance activities.
The individual will be part of the management team and report to the CEO.
Being based in the Stockholm area is not a pre-requisite.
- MD or PhD in relevant natural science.
- At least 7 years clinical study operations experience of which at least 2 years in project/program management roles, global experience is a merit.
- Experience from different clinical phases of drug development.
- Experience from driving accurate operational resource forecasting.
- Track record in managing clinical risk plans.
- Track record from operational strategy work.
- Proven expertise within clinical development and operational management.
- Proven experience from clinical study monitoring and leading CRO study teams.
- Proven experience from clinical study budget management.
- Experience from Regulatory Affairs is a merit.
- Excellent communication and medical writing skills
Welcome to apply through: www.haegercarlsson.com
Questions are answered by Gunilla Haeger +46(0)704 – 619 387, firstname.lastname@example.org
Anna Wikman +46(0)73-539 33 87, email@example.com