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Medical Director, Medical Affairs, Germany

Summary
To develop, lead, and deliver the Medical Affairs strategic plan for the country being aligned with European and Global strategies; operational activities and outcomes in order to create, optimize, and maintain excellence in scientific engagement between Zogenix and all relevant stakeholders to deliver an impactful and successful transition from the Development phase to the launch phase of all products with a particular focus on the lead product ZX008 for Dravet Syndrome.
Responsibilities
Identifies, maintains relationship with, develops and supports national and international Key Opinion Leaders in the country, in close collaboration with commercial and clinical colleagues.
Develop and implement a Country Medical Affairs strategy aligned to European/Global Medical Affairs Strategies to cover pre-launch market understanding; data generation required for market access; local language publication plans; local patient advocacy group strategy; support for local market access/reimbursement strategy and dossier development.
Manage reactively and support requests for early access from physicians and pharmacists
Inputs into the selection of local centers for Zogenix sponsored trials (Phase II-IV). Ensures that Zogenix local clinical trial activities are consistent with the product strategy. Provides input into the protocol synopses, study protocols, and final study reports for local phase IV trials.
Coordinates and tracks national Non-Company-Sponsored Investigator initiated trials and ensures the implementation of guidelines included in boundary documents.
Develops contacts with relevant nationally-organized patient groups, ensuring that their legitimate needs are fully considered and where appropriate incorporated into Zogenix clinical trial and medical-marketing strategy/activities.
Organizes and leads national medical advisory boards. Functions as primary contact with local collaborative groups and fosters medical and scientific information exchange with the national medical community.
Ensures medical information and pharmacovigilance support to contracted vendor as required
Provides regulatory-complaint clinical and scientific training and presentations for internal and external target groups, ensuring fair-balanced and consistent communication of medical and product-medical messages, within the brand and clinical strategies. Deals with medical information questions from the field.
Participates in reviewing, adapting to local requirements and language and approving materials produced by Zogenix International Limited Medical/Marketing function, as per current process and SOP.
Contributes, through medical expertise, to ensuring proper product labeling, reimbursement and funding in the country.
Consolidates and disseminates medical competitive intelligence to both local and central teams
Supports Key Account Managers (KAM) in the development of individual key-account's business plans and in the delivery of the relevant medical initiatives, trainings and programmes.
Travel approximately 80% of working time.
Requirements:
Minimum 5-6 years in pharmaceutical or biotech (preferred) companies with:
At least 3 years experience in medical affairs positions
Experience in clinical trial design & execution; analysis & interpretation of clinical data; management of clinical trial budgets
Relevant medical specialization in paediatric epilepsy will be an advantage
Experience in writing protocols is an advantage.
UK specific - General Medical Council UK registration
Skills and Capabilities:
Science based, marketing minded individual.
Strong project management skills.
Scientific/technical reading and writing skills are needed.
In-depth knowledge of the relevant therapeutic area(s)
Up-to-date awareness of current clinical practices.
Knowledge of local regulations related to promotion and industry supported scientific education activities.
Understanding of Pharmaco-economic principles and of National Health Care systems is preferable.
Effective presentation skills (various audiences).
Proven track record of adding value through robust and credible scientific discourse, innovation and insight
Languages
English and local language required.
Education
MD qualification is required. Relevant specializations may be an advantage



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