Medical Director (m/w/d)

Medical Director (m/w/d)

The Position:

The Medical Director, Germany, is leading the Medical Division including Medical Affairs, as well as overseeing Pharmacovigilance, Quality & Compliance, Regulatory Affairs & Thrombosis Medical Affairs, in Germany.

In addition, the position holder, is \“Stufenplanbeauftragter \“ in accordance with AMG §63a and AMWHV §19, and \“Informationsbeauftragter \“ for the dermatology area and deputy \“Informationsbeauftragter\“ for the thrombosis area.

Specifically, the Medical Director is responsible for the development and execution of the Medical Affairs Strategy and Plan.

Your Role:

Medical Affairs Leadership

• Provide medical / scientific strategic and operational expertise and leadership for all Medical Affairs activities
• Develop and maintain up-to-date knowledge of the medical and competitive developments and unmet needs in relevant therapeutic areas. Through engagements with key external experts and stakeholders, and participating in scientific congresses, provide medical insights and perspectives to guide the business strategy
• Strategic Planning for the affiliate Medical Affairs team, working closely with cross-functional colleagues to ensure alignment of strategy and to provide input into both strategic and operational decision-making processes, such as life cycle management plans, strategic launch plans, brand plans and global business plans
• Lead scientific and external engagement strategy for the affiliate and represent LEO Pharma in meetings with external stakeholders
• The position holder should be aware, align and adhere to global medical affairs objectives in line with company goals

Performance & Delivery

• Accountable for all Medical Affairs activities in the affiliate, developing, motivating, and maintaining a high performing Medical Affairs team, and continuing to advance a culture of continuous improvement and operational excellence
• Responsible for budgets, headcount, workload, and productivity of the Medical Affairs Department
• Set performance metrics and ensure that local Medical Affairs implementation plans are executed efficiently, and that resourcing, skills and capabilities are appropriate to meet business needs

Medical Excellence, Efficiency & Best Practices

• Drive adoption of Global Medical Affairs processes (e.g., KEE engagement, field medical excellence, publications, etc.) in the affiliate
• Accountable for local publication planning throughout the product life cycle (including congress abstracts, poster presentations, manuscripts, and symposium presentations) working in close collaboration with both local teams and Global Medical Affairs
• Accountable for the country field medical function/team, including development of an MSL strategy and tactical plan and its timely execution
• Identify opportunities and implement innovative solutions to improve organizational impact and / or efficiencies
• In cooperation with the Head of Medical Excellence & Operations and Affiliate Medical Directors, the position holder is expected to support the development of a strategy map on key medical activities that demonstrate medical impact, value and effectiveness by measuring performance of the medical activities through KPI´s and metrics

Talent Development

• Perform gap analysis of local capabilities and needs and facilitate appropriate training opportunities for local medical employees
• Identify talent in the affiliate and work with peers in other countries and global medical teams to identify appropriate opportunities to develop these employees
• Provide medical, strategic support and input to the operational team to help drive business development objectives
• Be recognized as a trusted partner with commercial teams providing medical guidance and timely input, aligning and supporting promotional engagement strategy
• Develop and execute strategies for evidence generation in collaboration with commercial colleagues in order to support regulatory approval, launch and customer access to products in the local market
• Contribute to the LEO7 Medical Affairs Country Medical Director team and the broader Rest of World Medical Affairs community, representing Germany, sharing medical needs and local customer insights, championing affiliate medical best practices and learnings with peers from other LEO Pharma affiliates
• Represent Medical Affairs in Leadership teams and contribute beyond the medical agenda

Governance & Compliance

• Responsible for local sign-off of proposed Investigator Initiated Studies (IISs) and Non-Interventional Studies (NISs) in the affiliate prior to submission for global review
• Maintain highest standards when it comes to safety, pharmacovigilance and medical information regarding LEO Pharma products
• Ensure that the affiliate operates an effective and compliant, promotional material review & approval process, and act as final medical signatory (may be delegated) for all promotional and scientific materials.
• Make sure that materials follow local codes of ethics and marketing authorizations.
• Ensure adherence to company standards, policies, and procedures: Accountable for enhancing affiliate medical personnel understanding of compliance requirements, risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls.

Germany specific governance

• Fulfillment of local duties as a \“Stufenplanbeauftragter\“ in accordance with AMG §63a and AMWHV §19:
  • Maintaining a local pharmacovigilance system
  • Collection, recording and assessment of drug risks, as well as coordination of necessary measures
  • Fulfillment of reporting obligations for drug risks
  • Assessment of the benefit-risk ratio of a LEO drug
  • Informing the authority about defects that could potentially lead to recalls or unusual restrictions on distribution, as well as counterfeit medicines.
• Fulfillment of local duties as Informationsbeauftragter in accordance with AMG Art. 74a) for the area of dermatology and Deputy \“Informationsbeauftragter\“ (according to AMG Art. 74a) for the area of thrombosis:
• Provision of medical expertise for internal and external enquiries and for the marketing strategies of the LEO portfolio, e.g. through training, advice and approval (information officer)
• Function of the information officer in accordance with the German Medicines Act (AMG), verifying the content of advertising material for compliance with the content of the registration and for medical correctness (reported to the Darmstadt Regional Council). Responsibility for packaging materials is delegated to the Head of RA. However, the main responsibility as information officer lies with the incumbent.

Your Profile:

Experience

• MD Degree preferred and experience within a similar role
• Minimum of 10 years demonstrable experience, within the pharmaceutical industry, in medical affairs and or in clinical research and development
• Solid knowledge of drug development, safety, regulatory, market access and reimbursement requirements
• Experience in dermatology preferred as well as launch experience
• Experience working with biologics preferred
• Excellent leadership and communication skills, with the ability to build strong relationships at all levels of the organization
• Fantastic stakeholder management both internally and externally
• Ability to translate strategy to execution and drive the organization forward in executing and delivering results.
• Highly accountable with the ability to lead, drive and embed change both technically and behaviourally
• Strong business and commercial acumen with the ability to influence and also identify cost efficiencies
• Track record of cross-functional collaboration (preferably with commercial, legal, regulatory, and medical communications)
• Strong goal orientation, an ability to make decisions and a history of meeting deadlines and objectives
• Strong English verbal and written communication skills
• Experience in developing and expanding key external expert relationships
• Skilled in developing, reviewing, understanding, and presenting clinical and scientific information to multiple audiences
• Creates and enhances a culture of compliance, integrity, pro-activeness, and collaboration Willing and able to undertake significant domestic and international travel (could be as much as 20-30%).

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