Therapeutic Area Lead, Oncology

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 & implements the Oncology

Medical Strategic Plan/ Local Annual Medical Plan activities in alignment with Brand strategy, and ensures that the medical initiatives meet the needs of patients /HCP’s and governance requirements.

The role will engage Thought Leaders in ESR/ISS’s, scientific exchange meetings and advisory board meetings, and define and deliver training on the scientific background of the product to internal and external stakeholders. The role has responsibility as 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 will be a critical part of the Medical Affairs Leadership Team.

Establish Ipsen as a scientific leader through proactive, updated and effective medical Input

• 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 MSL’s 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
• To ensure/facilitate Medical Information provided both 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 PSP’s, market research, PASS and ISS’s.
• Provide expert guidance to the governance of promotional/non-promotional activities
• Contribute to above country Medical Affairs initiatives
• Develop systems/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
• At 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 MSL’s.
• Create strategies/plans to share scientific data with the medical community by translating their clinical value and ensuring incorporation 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 CSS’s & ISS’s.
• Internally communicate competitive intelligence
• Work 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 insights
• Agile management of resources toward the highest priority areas for Ipsen Oncology as required
• Work closely with and have a dedicated focus on developing MSL’s and ASA staff to build experienced and expert capability in Medical Affairs customer engagement and governance
  
  

Facilitate medical evidence generation/confidence aligned to the brand strategies in priority TAs to meet unmet medical needs

• Drive company sponsored clinical research/ISS/RWE aligned to business strategy
• Oversight for driving data generation activities and reporting to above country
• Drive 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 products

• Support to develop dossier value pack and communicate it to Key Decision Makers
• Support market access activities that shape market understanding of disease, diagnosis and treatment options
• Proactive cross functional collaboration with regulatory and other teams in drug registration/re-imbursement aligned to the brand strategy Defines and delivers Scientific training/education
  
  

Provide medical expertise to shape regulatory/payor environment to achieve rapid and high-quality market access of Ipsen products

• Support to develop dossier value pack and communicate it to Key Decision Makers
• Support market access activities that shape market understanding of disease, diagnosis and treatment options
• Proactive cross functional collaboration with regulatory and other teams in drug registration/re-imbursement aligned to the brand strategy
  
  

Defines and delivers Scientific training/education

• Provide effective Medical/clinical education (basic science and disease knowledge, drug profile, clinical data) to internal/external stakeholders in line with needs of key stakeholders
• Ensures own knowledge and knowledge of team members is kept current to deliver optimal scientific exchange
  
  

Medical Governance and ensuring overall adherence to processes and regulation to enhance our reputation

• Accountable 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/regulations
• Adhere to good Pharmacovigilance practice
• Ensure 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 execution
• Supports and drives a Quality culture and contributes to the execution and implementation of the QMS and all aspects of GxP
• Ensures compliance with Ipsen code of conduct, Corporate Governance, Audit(s) requirements to meet internal/external regulations/codes
• Ensures that company confidentiality is maintained (i.e. intellectual property, product, strategic and salary information)
• Discloses potential breach of codes or conduct and implements CAPA’s
• Key member of the Medical Governance and Grants & Donation Committees. Participation in 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 (or related therapy 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
• An ability to travel