Medical Lead Entyvio®

Medical Lead Entyvio®

Requirements

• Advanced degree required (MD, PhD, or PharmD), preferably a minimum of 7 years total pharma industry experience.
• Clinical research experience within the pharmaceutical industry, CRO health-related consulting company, and/or biomedical/clinical experience within academia.
• Experience in synopsis/protocol writing and Medical Monitoring.
• Knowledge of clinical operations and at least 3 years’ experience working in the area of immune-mediated disorders, experience in Inflammatory Bowel Disease is desirable.
• Experience working on Global Products, engaging with International KOLs and delivering on a multinational value proposition for the assigned product.
• Demonstrated ability to work effectively in complex matrix environments.
• Knowledge of pharmaceutical industry dynamics and trends including a good understanding of the life cycle of a brand from cross-functional perspectives (e.g. marketing, pricing and reimbursement, supply chain).
• Excellent oral, written and presentation skills, including proven success in communicating ideas to build collaborative work relationships.
• Advanced interpersonal and negotiation skills including clear achievements in positively influencing key stakeholders.
• Ability to proactively predict issues and avoid problems.
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams.
• Diplomacy and positive influencing abilities.
• Fluency in English.

Responsibilities

• Leads flagships medical programs as defined by the Global Medical Affairs (GMA) Strategy Team and sub-teams.
• Leads GMA-driven evidence generation, taking into consideration the medical, scientific, regulatory and commercial considerations.
• Supports multi-disciplinary matrix teams through complex decisions.
• Collaborates with other Medical Strategy Team (MST) members, Commercial and Clinical stakeholders in establishing a medical strategy wholly aligned with the cross-functional plan.
• Investigates and analyses major trends to reach strategic decisions related to the brand.
• Directs the development of synopses and protocols and provide medical oversight and monitoring for Phase 3b/4 studies.
• Develops and maintain relationships externally through Advisory Boards, Professional Associations, Patient Advocacy, Professional Meetings and Conferences, and regular HCP scientific exchange, etc. to deliver Takeda’s scientific objectives.
• Attends relevant congresses or other relevant fora to maintain up-to-date scientific/medical knowledge.
• Manages budget for specific cost centers and provide direction and budget oversight.
• Contributes to the clinical strategy and leads key flagship programs, including the data generation plan which includes both clinical and non-clinical projects.
• Contributes to Phase 3b/4 research and RW data generation plans aligned with brand and market access strategy.
• Acts as a study Medical Lead for the GMA Medical Affairs Company Sponsored / Collaborative studies.
• Manages complex projects with a strategic mindset and leads by influence.
• Interprets data from an overall scientific standpoint in collaboration with Medical Communications and stands as a scientific and medical reference for the compound.
• Maintains attention to details, anticipates and mitigates problems.
• Prioritizes and responds in a fast-paced and dynamic environment.
• Directs activities involved in interactions to establish and maintain strong relationships with key opinion leaders relevant to Entyvio® and Inflammatory Bowel Diseases.
• These responsibilities include leadership roles in meetings with the key opinion leaders, establishment of strategy for Entyvio®, and developing documents required to outline the Company positions on research programs e.g. materials used for meeting presentations and formal responses to communications received from the regulatory organizations or opinion leaders.
• Lead roles will also be taken on the incorporation of advice/recommendations received into the design of clinical studies/programs as appropriate, accountable to senior leadership for the successful completion of related objectives.
• Is a core member of the Medical Strategy Unit, contributing to the Global Product Medical Plan and its implementation.
• Partners with the Commercial and Clinical stakeholders in establishing a medical strategy which is wholly aligned with the brand plan.
• Drives, articulates, and socialize an ongoing data-driven ‘context check’ to frame key data releases, extract and exploit value and pre-identify and address data gaps supporting both assets and disease area assumptions (related to the context).
• Responsible for driving alignment on medical content/messaging within the organization to ensure maximal functional and regional input.
• Participates in the scientific communication plan, and further development of the publications strategy for assigned compounds by providing scientific input, in collaboration with the publications team, external experts, authors and the internal team.
• Strategic approach focused on improving Takeda’s impact of activities addressing diversity, equity, inclusion, and health equity across the therapeutic area or portfolio.
• Contributes to both strategic internal and external medical education activities, medical/scientific information exchange.
• Brings medical/scientific expertise and gather medical/scientific insights supporting research/data generation activities.
• Represents GMA supporting ‘Disease Area Strategies’.
• Supports Access teams with medical/scientific expertise.
• Contributes to creating the Asset Medical Strategy document with input from the Regional/Local Operating Company Medical Directors.
• Provides functional leadership to contribute to successful launch and life cycle management of a prioritized global brand.
• Responsible for review and certification of assigned brand-related clinical content material development for medical education, medical communication, publications and Key Opinion Leader engagement plans.
• Provides medical-scientific training to internal/external stakeholders as required.

Preferred Qualifications

• Proven experience in and understanding of multiple regional/country markets.
• Deep understanding of the brand(s)/therapeutic area and the stakeholders’ needs.
• Fluency in more than one language.