Therapeutic Area Lead, Oncology

2 days ago


Melbourne, Victoria, Australia Ipsen Full time
Overview

Reporting to the Medical Director, the Therapeutic Area Lead, Oncology will lead strategy and operational activities. This leadership position provides strategic medical affairs advice to the business, develops and implements the Oncology Medical Strategic Plan and Local Annual Medical Plan activities in alignment with Brand strategy, and ensures that medical initiatives meet the needs of patients and HCPs and governance requirements. The role engages Thought Leaders in ESR/ISS's, scientific exchange meetings and advisory boards, and defines and delivers training on the scientific background of the product to internal and external stakeholders. The role is the senior medical reviewer for Oncology promotional/non-promotional activities and medical governance. It will lead and coach the Oncology Medical Affairs team for the relevant therapeutic areas/disease states. The role is a critical part of the Medical Affairs Leadership Team. Establish Ipsen as a scientific leader through proactive, updated and effective medical input.



Responsibilities
  • Be accountable for the performance of Ipsen ANZ Medical Affairs Oncology
  • Continuously 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 plan
  • Lead 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 opportunities
  • Provide medical leadership on faculty and content development for medical programmes including national congresses, advisory boards, scientific exchange meetings, publications, CMEs to meet identified needs
  • Ensure that Medical Information provided to external and internal customers is timely, relevant, accurate and scientifically balanced
  • Provide medical expertise to local area/regional/global brand teams
  • Provide medical input to Phase 1 to 4 study protocols, study feasibility and support operational delivery
  • Provide medical expertise to support PSPs, market research, PASS and ISSs
  • Provide expert guidance to the governance of promotional/non-promotional activities
  • Contribute to above country Medical Affairs initiatives
  • Develop systems and processes to deliver on operational objectives
  • Quantify and qualify lead and lag key performance indicators for medical program/activity success


Engage external customers to establish Ipsen as a scientific leader
  • Be accountable for Oncology Medical Affairs Thought Leader and medical customer engagement plans
  • Spending 30-40% of field time on 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 clinical value and integrating it into business strategies
  • Attend relevant scientific congresses and HCP meetings to gather new knowledge on Ipsen compounds, competitor information and therapeutic areas
  • Conduct professional scientific communication or presentations with key Thought Leaders
  • Liaise with local investigators and facilitate the generation/execution of CSSs and ISSs
  • Internally communicate competitive intelligence
  • Collaborate with the Head of Medical Operational Excellence (HOMEX) to drive scientific leadership and medical operational excellence
  • Coordinate Oncology Medical Affairs customer engagement with Commercial to enable targeted engagement with appropriate resource allocation and regular sharing of insights
  • Manage resources agilely toward the highest priority areas for Ipsen Oncology as required
  • Develop and focus on building MSLs and ASA staff to strengthen Medical Affairs customer engagement and governance


Facilitate medical evidence generation aligned to brand strategies in priority TAs
  • Drive company-sponsored clinical research/ISS/RWE aligned to business strategy
  • Oversee data generation activities and reporting to above-country teams
  • Drive research discussions with customers to develop studies that 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 products
  • Develop dossier value packs and communicate them to Key Decision Makers
  • Support market access activities that shape understanding of disease, diagnosis and treatment options
  • Proactively collaborate with regulatory and other teams on drug registration/reimbursement aligned to the brand strategy


Provide scientific training and education
  • Provide effective medical/clinical education (basic science and disease knowledge, drug profile, clinical data) to internal/external stakeholders in line with the needs of key stakeholders
  • Ensure knowledge within the team remains current to deliver optimal scientific exchange


Medical governance and adherence to processes and regulations
  • Accountable for ensuring Promotional/Non-Promotional Compliance/Governance: provide medical input to the creation, development and approval of promotional/non-promotional material and ensure all material complies with internal SOPs and local regulations
  • Adhere to good Pharmacovigilance practice
  • Ensure clinical studies are conducted in accordance with SOPs and cGCP; support Clinical team to select appropriate investigators and sites, optimizing quality, delivery and trial execution
  • Support and drive a quality culture and contribute to the execution and implementation of the QMS and all aspects of GxP
  • Ensure compliance with Ipsen code of conduct, Corporate Governance, audit requirements to meet internal/external regulations/codes
  • Ensure that company confidentiality is maintained (i.e., intellectual property, product, strategic and salary information)
  • Disclose potential breaches of codes or conduct and implement CAPAs
  • Participate in Medical Governance and Grants & Donations Committees and other governance committees as required


Knowledge, Abilities & Experience
Education / Certifications
  • A Qualified Doctor/Medical degree with specialization, or appropriate experience, in the required product or disease area
  • MSc/PhD in a scientific discipline
  • MBA


Experience
  • Medical/Scientific knowledge in the responsible disease area ( Oncology preferred )
  • Excellent presentation and communication skills
  • Project management/operational excellence experience
  • Prior pharmaceutical (or similar) industry experience (at least 7 years)
  • Strategic thinking capabilities/ Stakeholder management
  • Strong business and financial acumen
  • Demonstrated people management experience (at least 2 yrs). Ideally also managed field based medical teams
  • Demonstrated experience in Medical Affairs
  • Demonstrated Leadership capabilities
  • Expert medical governance capabilities
  • Ability to travel


Seniority level
  • Not Applicable


Employment type
  • Full-time


Job function
  • Sales and Business Development


Industries
  • Pharmaceutical Manufacturing
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