Director Medical Affairs

hace 2 semanas

Bogotá, Bogotá D.E., Colombia IPSEN A tiempo completo

Title:

Director Medical Affairs

Company:

Ipsen Pharma (SAS)

Define the strategy for Medical Affairs locally and execute it: - Create and implement strategic and operational plans in the country in line with the mission, strategy, and values of the Ipsen Group, thus achieving Global Medical Affairs and Local targets. - Secure the successful execution of the medical strategy in line and consultation with the responsible interdisciplinary teams. - Overall responsible for resource allocation, budget control for the Medical Affairs Department, and corrective measures as necessary. - Perform due medical diligence, ensuring that Ipsen products retain a positive benefit/risk ratio, unconditionally placing patient safety in the foreground. - Ensure proper life-cycle management for all new and existing products. - Represent the country internally at the Global Medical Affairs level.

Manage the daily Medical Affairs activities: - Provide clinical expert concepts and, where appropriate, training on products and therapies for internal and external customers. - Coordinate and supervise technical aspects of promotional information, clinical studies, and training to commercial representatives, ensuring the compliance with our SOPs, GCP, and applicable laws and regulations. - Oversee the approval of the Medical Education grants, sponsorships, and donation process where applicable.
-
Oversee Drug Safety activities in the country.
  • Ensure that all products/therapeutic areas are supervised by medical personnel with the proper expertise and training and that the interdisciplinary teams get the appropriate medical input.
  • Ensure that all reasonable and necessary medical measures are planned and executed to add value for patients and customers, contributing to the business success in the corresponding indications.
  • Updating and maintaining current clinical knowledge and experience/expertise
  • Activities in Medical Affairs include but are not limited to medical information, medical education, data generation, medical publications, representation, patient safety, and KOL management.

Oversee local Clinical Operations & Execution: - Identify and implement post-approval non-registration Clinical Sponsored Studies, as well as Investigator Initiated Studies aligned with Global Medical Affairs and the Asset Data generation strategy. - Ensuring the timely, legally compliant, high-quality performance of all types of studies (including Ipsen studies, national, international, interventional, non-interventional, prospective, and retrospective studies, PASS, PAES, ISS), within the available and agreed budgets, in consultation with the respective teams and in line with the prescribed corporate strategy. Develop strategies where appropriate to leverage RWD and develop relevant RWE to support local and global objectives, including but not limited to potential label extensions and market access, and in alignment with the therapeutic area products life cycle management. - Taking suitable measures in the event of deviations.

Create a high performing team to execute the local Medical Affairs strategy: - Promote a performance-oriented, customer-focused environment through the development, motivation, and effective leadership of the Medical Team. - Manage a medical Team of office based Medical Advisors (Medical Affairs Managers), Medical Information, and field based MSL and MSL Manager, among other possible roles according to an evolving local medical structure. - Recruit highly qualified team members with clearly defined roles and corresponding skillsets. - Set-up and follow carefully clear objectives and responsibilities for the team. - Support of efficiency and effectiveness by implementing appropriate management processes, and sharing ideas and best practices.

Represent Ipsen with external partners / authorities: - Represent the Country Medical Team and Ipsen's medical position to external opinion leaders, medical organizations, Patient organizations and authorities. - Cooperate with colleagues from other departments to build proactive, effective cross-function communication and build possible collaborations externally. - Provide medical-scientific point of contact for Key Thought Leaders (KTL). - Represent Ipsen locally with partner firms.

Education / Certifications:

  • Degree in Medicine or other higher life science qualifications
  • Postgraduate degree / experience in Pharmaceutical Industry/Clinical trials would be desirable

Experience:

  • Minimum 10 years' experience in Pharmaceutical Industry or biotechnology companies
  • Must have significant experience in Medical Affairs, including design and oversight of Phase IV clinical studies
  • At least 5 years of management or leadership experience
  • Comprehensive understanding of the pharmaceutical industry, regulatory and clinical operations
  • Preferred: experience in Oncology
  • Ability to work with high workload and time pressure
  • Computer liter

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