Head of Medical Affairs

Description

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.

For our Business Development and Licensing organization based at our Headquarters in Lausanne, we are looking for a

Head of Medical Affairs

Mission

The Head of Medical Affairs is closely leading and overseeing the Debiopharm medical affairs strategy with the aim to support Debiopharm pipeline products. She or he works closely with clinical development, business development, marketing, regulatory, market access, pharmacovigilance, commercial partners, project teams to ensure that development and implementation of medical affairs plans are aligned with product strategies, Debiopharm business model and ultimately strengthen our value-driven out licensing packages.

Key responsibilites

Lead the global Medical Affairs activities including investigator-led research, KOLs networking, educational programs, congress planning, scientific conferences, internal and external training:
With core teams and in line with DPI business model and development strategy, define and run an evidence plan that goes beyond DPI clinical development plan, exploring and leveraging notably on external collaborations, ISTs, Cancer Research Groups,
Maintain strong professional relationships with external medical societies, international thought leaders, guideline committees, patient advocacy groups, and payer organizations (particularly those in Oncology),
Lead the development and execution of overarching advocacy strategy including defining, standardizing and executing best practices for patient advocacy engagement across the continuum of drug discovery and commercialization,
Partner with Clinical Operations and Clinical Development to facilitate enrolment of DPI sponsored clinical trials in, notably, well ahead of phase II/III studies, identifying, establishing and nurturing relationships with key potential investigators with the aim to get our studies in the right hands and in time,
Represent Debiopharm at local/regional/international scientific congresses, professional society meetings and patient advocacy forums,
Respond to unsolicited requests for information from healthcare professionals that are received either directly or indirectly, in accordance with all compliance regulations and policies,
Build high value-added continuous medical educational programs for internal and external stakeholders,
Work closely with the Market Access team to develop compelling medical evidence to support optimal patient access to medicines,
Foster an environment of compliance and integrity by managing and adhering to all company policies and Legal and Regulatory guidelines.
Lead the global medical strategies and provide scientific input and expertise in the design and approval of labelling extension initiatives worldwide (prostate cancer, breast cancer, endometriosis, female infertility, central precocious puberty),
Collaborate closely with the medical teams of triptorelin commercial partners leading medical initiatives,
Utilizes knowledge and understanding of business environment to create new business opportunities,
Partner with Commercial/Marketing teams to ensure timely, accurate, and compliant preparation and review of promotional and educational material,
Participate in the development and review of clinical protocols, clinical study reports, investigator brochures, DSURs, and other clinical and regulatory documents,
Participate to oral and written exchanges with Regulatory Authorities for registration of triptorelin in any of its existing or new indications, and provides timely responses to Regulatory Authorities requests worldwide,
Provide medical assessment of post-marketing adverse event cases related to triptorelin formulations manufactured by DPI.

Triptorelin duties

Lead the global medical strategies and provide scientific input and expertise in the design and approval of labelling extension initiatives worldwide (prostate cancer, breast cancer, endometriosis, female infertility, central precocious puberty),
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