Title:
Hybrid Scientific Advisor Rare Disease (12 months fixed term)
Company:
Ipsen Pty Ltd
About 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 company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!
For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.
Job Description:
Please note that this is a 12-month fixed term contract for a maternity leave cover.
The Hybrid Scientific Advisor Rare Diseases is instrumental in providing strategic and tactical medical expertise and ensuring its implementation across the assigned therapy area and territory coverage. The role will develop and maintain close partnerships with Thought Leaders (TLs) and key stakeholders in paediatric hepatology/gastroenterology and rare cholestatic liver diseases and actively contribute to medical strategy and cross-functional programs for the Country Brand Operating Plan for Bylvay.
The role also includes providing non-promotional, high-level scientific, medical, and educational support to Healthcare Professionals (HCPs) and other stakeholders to enable evidence-based clinical decision-making in the management of cholestatic pruritus and related disease burden. Through high-quality scientific exchange, insight gathering, and evidence generation support, this role helps position Ipsen as the scientific partner of choice for Bylvay and the broader paediatric hepatology/rare disease community.
Main Responsibilities:
Provide scientific information and support (Bylvay)
- In close coordination with existing medical information resources, respond professionally and quickly to documented unsolicited requests from the field and external stakeholders (e.g., paediatric hepatologists, gastroenterologists, specialist nurses, pharmacists) for scientific and clinical information relevant to Bylvay and cholestatic liver disease.
- Communicate on scientific, clinical, and technical topics (including disease burden, pruritus/QoL outcomes, and evidence developments) in line with Ipsen SOPs and the Medicines Australia Code of Conduct.
- Lead the organisation and scientific support of key local events (e.g., advisory boards, round-tables, disease education meetings, congress activities, satellite symposia) relevant to paediatric hepatology, gastroenterology, and rare cholestatic liver diseases.
Develop and maintain therapy area and product knowledge (Bylvay)
- Develop and maintain a deep understanding of Bylvay, the cholestatic liver disease landscape, current standards of care, and evolving evidence to support external HCPs/TLs and internal stakeholders.
- Effectively contribute to external HCP/TL engagements (e.g., advisory panels, round-tables) to stimulate high-quality scientific exchange and incorporate evolving evidence and clinical practice insights relevant to Bylvay and rare cholestatic liver diseases.
Medical Affairs Excellence and Business Support
- Sets and aligns Medical Affairs strategy by effectively working with the medical/marketing/sales team on brand strategies and Country Brand Operation Plans, including medical tactics and budget management.
- Collect actionable insights from interactions with stakeholders to develop strategies that can benefit patients.
- Support Market Access/Patient Affairs by providing relevant clinical and HEOR data to ensure optimal access and reimbursement conditions for Ipsen products.
- Advising the Brand teams on the most suitable approach for supporting the company’s products from the medical/regulatory point of view.
- To support the Marketing department in developing, reviewing, and approving promotional materials from a medical point of view, ensuring that all local legal requirements and other applicable (e.g., Ethical codes) and internal SOPs are met.
- Develop and execute KOL engagement plan for the relevant therapy areas. Identify and develop KOLs to be Ipsen’s national or international speakers.
- Ensure the delivery of timely and accurate medical training to internal staff to ensure a high level of medical knowledge and understanding aligned with Ipsen requirements and relevant standards.
Supervise and successfully manage the execution of evidence generation projects
- Propose clinical centres/rare disease networks for participation in Company-Sponsored Studies (CSS) and local evidence generation initiatives (e.g., real-world evidence, registries, outcomes/QoL projects) aligned to Bylvay and the therapy area strategy.
- Ensure appropriate design, monitoring and reporting of clinical/epidemiological and data studies, including selection of endpoints that reflect clinical relevance and patient impact (where applicable, pruritus and quality-of-life measures).
- Act as the key contact person for the HQ Clinical Operations and/or the contracted CRO companies.
- Lead and supervise proper execution of Grants and CSS/ISS/data generation.
Regulatory and Pharmacovigilance
- Supports Regulatory to meet all regulatory requirements, including timely and quality submissions to relevant regulatory authorities by communicating scientific information to regulators in the pre-registration phase (reactively).
- To ensure the required medical support to pharmacovigilance.
- On-time reports of spontaneous adverse events and technical complaints about all Ipsen products.
- Serve as a designated backup for LMI (local medical information) and PV (Pharmacovigilance) activities, ensuring seamless support and continuity of operations as needed.
Compliance and Governance
- Ensure that scientific support is informed, balanced, current, and complies with the spirit and letter of EFPIA codes or regulatory rules and Ipsen SOPs. This includes but is not restricted to, maintaining high professional standards of conduct in line with Ipsen Company Standard Operating Procedures, with a duty of care to the company's reputation.
- Demonstrated capacity to build strong relationships across functions and to work closely with all people across the business.
Knowledge & Experience:
- At least 5 years experience in the pharmaceutical industry in a Medical Affairs role (specialisation in rare disease and/or paediatric specialty care and cholestatic liver disease preferred).
- Strong existing network of KOLs and key stakeholders (especially in paediatric hepatology and gastroenterology, liver transplant/referral centres, and rare disease networks).
- Knowledge of and current training in international/local studies and GxP (GCP, GPvP, GMP, GDP and other applicable Instruments and regulations governing clinical research, medical information, and scientific communication.
- An understanding of the drug development process and a good knowledge of the therapeutic area (experience in hepatology/gastroenterology and/or rare cholestatic liver diseases is an advantage).
- Demonstrated experience in successfully working with a cross-functional team of people (a mix of experience, skill sets and roles)
- Able to elicit the knowledge gap in the audience and customise the presentation to communicate the appropriate scientific data.
- Able to work independently with minimal supervision.
- Provide constructive advice and feedback on strategies and actions to bring better outcomes to patients.
- Knowledge of Medicines Australia Code of Conduct
- Excellent verbal, written, interpersonal and influencing skills.
Education / Certifications:
- Medical/Pharmacy/PhD degree
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