Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs.
Our therapeutic areas of focus include sleep, and we are investing in our pipeline and portfolio to deliver therapeutic options for the sleep community. Jazz is a recognized leader in sleep medicine, and will, for example, present 20 abstracts spanning the company's sleep portfolio at the 32nd Annual Meeting of the Associated Professional Sleep Societies, known as "SLEEP", in Baltimore from June 3-6, 2018.
Primary Objective/ Purpose of Position:
This position will work in the team establishing the Sleep Business Unit outside of the US and, as part of that, play a key role in the EU launch of the investigational medicine Solriamfetol, which may be filed with EMA later this year.
This position will lead the Medical Affairs function in the Sleep Business Unit and be responsible for the development of overall Medical Affairs strategy and activities, as well as building the Medical Affairs team and represent the Medical Affairs function of Business Unit internally and externally.
A top candidate will feel at home in a fast-paced, agile environment with a start-up business feel, and will be intrigued by venturing into unchartered waters with a team of enthusiastic explorers.
- Help build the 100 pers.+ Sleep Business Unit outside the US, guiding the company’s thinking on Medical Affairs structure, areas of expertise, work streams, investment, talent acquisition, etc.
- Lead the Medical Affairs function within the Solriamfetol European launch team and drive product adoption within EMA-approved indications.
- Provide day-to-day clinical and medical guidance while working closely on joint projects with the medical affairs team and other departments within the organization (clinical development, commercial, etc.). Projects will include medical affairs studies, scientific congress/conference strategy and planning, advisory boards, development of educational goals, for medical education, publications, field force training, review of medical information standard response letters, health economics and epidemiology analyses, and marketing/policy related projects.
- Identify, develop, and maintain relationships with thought leaders. Collaborate with thought leaders to develop clinical therapeutic concepts that warrant additional study, identify messages for scientific communications based on preclinical or clinical data, and gain feedback on strategies to support the scientific and medical affairs plan for marketed products.
- Collaborate with and provide scientific and clinical support and training for internal departments, including Marketing, Sales, Medical Science Liaisons, Clinical Operations, Research, Corporate Development, Market Access, Government Policy, and Investor Relations, and for external audiences, such as patient advocacy groups, physicians, other health care providers, and formulary and clinical guidelines decision makers.
- Provide scientific input into manuscripts for publication and presentation at scientific meetings
- Participate in appropriate cross-functional and cross-company Clinical and Commercial teams to inform brand strategies and tactics and represent Medical Affairs.
- Collaborate with Clinical Development in the strategic planning, management, and execution of Phase IIIB and Phase IV trials. Define the medical strategy governing Investigator Initiated Research and direct the proposals review and grants process.
- Provide clinical and scientific support in responding to inquiries from healthcare professionals and managed care organizations.
- Provide medical review of promotional material.
- Monitor ongoing Medical Affairs performance and stakeholder feedback in a robust fact-based business review process and identify opportunities for improvement, focusing on the development of efficiencies and operational improvements, such as administration efficiency, cost control, revenue management, legal compliance and human resource management.
- Manage Medical Affairs resources (including budget) across the Business Unit
- Work with the Global Molecule Team to evaluate and develop additional Solriamfetol indications.
- Work with the Business Development Team to assess the strategic fit of other potential assets within the broader CNS space.
- Provide thought leadership, industry best practices, trends, risks, etc.
- Act decisively and independently, having the confidence and ability to provide clear direction and make decisions (strategic & tactical) without guidance or affirmation (but knowing when to inform/seek leadership buy-in)
- Engage constructively challenge others across all leadership levels.
- Establish clear roles, responsibilities, objectives and metrics for your team members.
- Develop people by proactively investing in development of others
- Ensure compliance with company and regulatory policies and requirements.
Other duties as assigned include, but not limited to, projects and initiatives relating to Pricing, Mergers and Acquisitions, and other corporate level functions.
- MD degree.
- Considerable experience within the broader therapeutic area (CNS), including product launches.
- Previous (>10 years) medical affairs or clinical development experience in sleep, CNS or psychiatry highly desired.
- High degree of professionalism, integrity and collaboration required.
- Exceptional verbal and written communication skills.
- Experience with post marketing Phase IV and Investigator initiated studies preferred.
- Experience with strategic and tactical planning for marketed products preferred.
- Strong leadership, team building, negotiation and ability to execute.
- Travel Required
Jazz Pharmaceuticals is an Equal Opportunity Employer.
Jazz Pharmaceuticals is an Equal Opportunity Employer.