Global Medical Affairs Director Neurosciences

Company: Ipsen Biopharmaceuticals, Inc.
Location: Cambridge
Posted on: January 12, 2022

Job Description:

Title:Global Medical Affairs Director NeurosciencesCompany:Ipsen Pharma (SAS)Job Description:Support the Dysport Asset Medical Lead, lead PhIV international studies, lead injection training medical activities and provide medical guidance and expertise across the organisation and externally.Main responsibilities / job expectations Lead global PhIV studies in close cooperation with Clinical Operations, regions and centers in charge of implementation:Develop synopsisDesign protocol in collaboration with medical WritingProvide medical expertise and follow-up during centers selection and trial completionGenerate CSR & study communicationChallenge risk mitigation and discuss corrective actions proposed by clinical operations or regionsEnsure GCPs, Ethics and medical compliance are applied within all programs, and report to CMO on these matters; set-up and coordinate appropriate monitoring processes, in coordination with Clinical Operations and regionsCoordinate and follow-up local /affiliates studies, in close cooperation with regions medical teams :Define guidelines for local medical functions to design local clinical trialsProvide medical expertise to Medical Affairs Review Committee on affiliates proposalsProvide support for centers selectionApprove protocol synopsis and objectivesFollow-up and support until completionWorks directly with the Head of GMA Neuroscience and the Dysport Asset Medical Lead to plan and execute a variety of projects to support the medical and overall franchise strategies for an asset multi-indication.Drive and manage all medical affairs activities for Dysport indications in close collaboration with global and local medical affairs as well as cross-functional teams.Represent medical affairs as a proactive contributor in various cross-functional teamsDevelop and implement indication specific medical affairs strategy, incl. data generation strategyDevelopment and execution of annual global planIndication specific budget planning and managementAble to work independently, provide input and take initiative to further develop specific projects while adhering to timelines and identifying ways to measure impact of each projectWorks with the Head of GMA Neuroscience to develop annual medical affairs strategic and tactical plans based on product and disease state.Responsible for the development and execution of projects that will provide more extensive background, additional data or answers to questions in response to issues that arise relative to commercial, scientific or data needs.Supports the development of complex clinical and real-world data through clinical trials, database analyses and investigator studies.May serve as the point person for the medical review at Promotional Review Committees.Collaborates cross-functionally in multiple areas potentially including publication planning, speaker education programs, advisory board meetings, evidence generation, manuscript development and review, development of medical affairs field resources, and conference preparation and management.Represents the company to groups of experts including medical professionals, societies, and regulatory at scientific meetings. Regular communication is expected with the external medical community to remain abreast of issues in the field and to provide medical support and direction to them.Engagement with targeted key opinion leaders, key institutions, prominent academic and clinical investigators, and leaders of the medical community in scientific discussions, consistent with Medical Plan objectives.Attends major conferences and helps coordinate medical affairs activities at conferences and may present to external audiences.Work with cross functional teams to provide scientific and clinical expertise/input into strategic and tactical decisions in support of the portfolio.Actively contribute medical and scientific input to relevant internal Brand, Medical Affairs, and Managed Markets teams regarding product strategy.Participate in planning of evidence generation (e.g. clinical and RWE studies).As a Medical expert, supply medical input to the Life Cycle Management (LCM) programs-- -Knowledge, abilities & experienceThe ideal candidate will have an MD, PhD or PharmD, with 10 years experience in medical affairs), including Global Medical affairs, clinical research experience in the key or related therapeutic areas.Key Technical Competencies RequiredMust have demonstrated organizational skills to manage PhIV clinical trials and multiple projects simultaneously.Must demonstrate strong written and verbal communication skills along with excellent judgment and ability to work in a matrix team environment.Ability to travel to domestic and international conferences, which will include occasional weekend travel, is required.Demonstrated ability to proactively and positively engage teams through multiple communication channels including telephone, e-mail, Internet, and face-to-faceDemonstrated high level of personal integrity, emotional intelligence, flexibilityDemonstrated ability to build positive constructive relationships with cross-functional team membersAbility to initiate and maintain relationships throughout the medical communityAbility to understand and effectively communicate scientific information; respond to inquiries and address needs of key stakeholdersUnderstanding of the highly regulated biopharmaceutical industry environmentDans le cadre de ses recrutements IPSEN s'engage au respect de l'-- -galit-- - de traitement des candidats, ind-- -pendamment du sexe, de l'-- --- -ge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalit-- -, du handicap ou de l'appartenance -- --- - un syndicat.

Keywords: Ipsen Biopharmaceuticals, Inc., Cambridge , Global Medical Affairs Director Neurosciences, Healthcare , Cambridge, Massachusetts