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Therapeutic Area Lead, Oncology page is loadedTherapeutic Area Lead, OncologyApply locations Melbourne time type Full time posted on Posted Yesterday job requisition id R-19320Title:Therapeutic Area Lead, OncologyCompany:Ipsen Pty LtdAbout Ipsen:Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the companys success. Join us on our journey towards sustainable growth, creating real impact on patients and society!For more information, visit us at and follow our latest news on LinkedIn and Instagram .Job Description:Reporting to the Medical Director, the Therapeutic Area Lead, Oncology will lead strategy and operational activities. This leadershipposition provides strategic medical affairs advice to the business, develops & implements the OncologyMedical Strategic Plan/ Local Annual Medical Plan activities in alignment with Brand strategy, andensures that the medical initiatives meet the needs of patients /HCPs and governance requirements.The role will engage Thought Leaders in ESR/ISSs, scientific exchange meetings and advisory boardmeetings, and define and deliver training on the scientific background of the product to internal andexternal stakeholders. The role has responsibility as the senior medical reviewer for Oncologypromotional/non-promotional activities and medical governance. It will lead and coach the OncologyMedical Affairs team for the relevant therapeutic areas/disease states. The role will be a critical part ofthe Medical Affairs Leadership Team.Establish Ipsen as a scientific leader through proactive, updated and effective medical InputBe accountable for the performance of Ipsen ANZ Medical Affairs OncologyContinuously acquire and update necessary scientific knowledge on the therapeutic areas and relevant compounds.Develop and implement the local medical plan to address unmet medical needs in priority disease/strategic areas and ensure alignment with the brand plan.Manage the Oncology medical affairs team in order to generate insights for development of the local medical planLead and develop the Oncology MSLs to deliver excellence in field interactions. Establish clear qualitative and quantitative performance measures that monitor performance for the business, team and individuals.Develop and implement Oncology pre-launch medical plan/activities for new products at least 18 months prior to the planned launch to address key clinical and scientific opportunitiesProvide medical leadership on faculty and content development for medical programmes including national congresses, advisory boards, scientific exchange meetings, publications, CMEs to meet identified needsTo ensure/facilitate Medical Information provided both to external and internal customers is timely, relevant, accurate and scientifically balancedProvide medical expertise to local area/regional/global brand teamsProvide medical input to Phase 1 to 4 study protocols, study feasibility and support operational deliveryProvide Medical expertise to support PSPs, market research, PASS and ISSs.Provide expert guidance to the governance of promotional/non-promotional activitiesContribute to above country Medical Affairs initiativesDevelop systems/processes to deliver on operational objectivesQuantify and qualify lead and lag key performance indicators for medical program/activity successEngage external customers to establish Ipsen as a scientific leaderBe accountable for Oncology Medical Affairs Thought Leader and medical customer engagement plansAt least 30-40% of time in field is required for engagement with the highest priority HCPs and key external stakeholders and/or in-field coaching of Oncology MSLs.Create strategies/plans to share scientific data with the medical community by translating their clinical value and ensuring incorporation into business strategiesAttend relevant scientific congresses and HCP meetings to gather new knowledge on Ipsen compounds, competitor information and therapeutic areasConduct professional scientific communication or presentations with key Thought LeadersLiaise with local investigators and facilitate the generation/execution of CSSs & ISSs.Internally communicate competitive intelligenceWork closely with the Head of Medical Operational Excellence (HOMEX) to drive scientific leadership and medical operational excellence.Coordinate Oncology Medical Affairs customer engagement team with Commercial to enable targeted customer engagement with appropriate resource allocation and the regular sharing of insightsAgile management of resources toward the highest priority areas for Ipsen Oncology as requiredWork closely with and have a dedicated focus on developing MSLs and ASA staff to build experienced and expert capability in Medical Affairs customer engagement and governanceFacilitate medical evidence generation/confidence aligned to the brand strategies in priority TAs to meet unmet medical needsDrive company sponsored clinical research/ISS/RWE aligned to business strategyOversight for driving data generation activities and reporting to above countryDrive research discussions with customers to develop studies that will fulfil global and local business strategies.Participate as a key member of the brand team.Provide medical expertise to shape regulatory/payor environment to achieve rapid and high-quality market access of Ipsen productsSupport to develop dossier value pack and communicate it to Key Decision MakersSupport market access activities that shape market understanding of disease, diagnosis and treatment optionsProactive cross functional collaboration with regulatory and other teams in drug registration/re-imbursement aligned to the brand strategy Defines and delivers Scientific training/educationProvide medical expertise to shape regulatory/payor environment to achieve rapid and high-quality market access of Ipsen productsSupport to develop dossier value pack and communicate it to Key Decision MakersSupport market access activities that shape market understanding of disease, diagnosis and treatment optionsProactive cross functional collaboration with regulatory and other teams in drug registration/re-imbursement aligned to the brand strategyDefines and delivers Scientific training/educationProvide effective Medical/clinical education (basic science and disease knowledge, drug profile, clinical data) to internal/external stakeholders in line with needs of key stakeholdersEnsures own knowledge and knowledge of team members is kept current to deliver optimal scientific exchangeMedical Governance and ensuring overall adherence to processes and regulation to enhance our reputationAccountable for ensuring Promotional/Non-Promotional Compliance/Governance: Provide medical input to the creation, development and agreement of promotional/non-promo material and ensure all material is in line with internal SOPs and meets Business Ethics (BE) and local code/regulationsAdhere to good Pharmacovigilance practiceEnsure clinical studies are carried out in accordance with SOPs and cGCP. Support Clinical team to select appropriate investigators and sites optimising quality, delivery and effective trial executionSupports and drives a Quality culture and contributes to the execution and implementation of the QMS and all aspects of GxPEnsures compliance with Ipsen code of conduct, Corporate Governance, Audit(s) requirements to meet internal/external regulations/codesEnsures that company confidentiality is maintained (i.e. intellectual property, product, strategic and salary information)Discloses potential breach of codes or conduct and implements CAPAsKey member of the Medical Governance and Grants & Donation Committees. Participation in other governance committees as requiredKnowledge, Abilities & ExperienceEducation / Certifications:A Qualified Doctor/Medical degree with specialization, or appropriate experience, in the required product or disease areaMSc/PhD in a scientific disciplineMBAExperience:Medical/Scientific knowledge in the responsible disease area (or related therapy area). Oncology preferred.Excellent presentation and communication skillsProject management/operational excellence experiencePrior pharmaceutical (or similar) industry experience (at least 7 years)Strategic thinking capabilities/ Stakeholder managementStrong business and financial acumenDemonstrated people management experience (at least 2 yrs.). Ideally also managed field based medical teams.Demonstrated experience in Medical AffairsDemonstrated Leadership capabilitiesExpert medical governance capabilitiesAn ability to travel#LI-Hybrid#LI-CT1IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships. #J-18808-Ljbffr