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Head Of Medical Affairs, Italy - Rome - Selecta sas
Descrizione
At Genmab, we are dedicated to building extraordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases.We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science.
We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose.
Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit?
Then we would love to have you join us
The Role
The Head of Medical Affairs, Italy will lead the expansion and execution of Medical Affairs activities, as Genmab establishes a fully operational Italian affiliate.
Reporting directly to the European Medical Affairs organization, the incumbent will serve as the senior medical affairs leader in Italy, responsible for shaping the national medical strategy to deliver the company's first Italian launch together with further expansion of a strong existing research footprint, whilst ensuring continued alignment with regional and global priorities.
This role offers a unique blend of strategic leadership and hands‑on execution in a biotech environment characterized by agility, innovation, and scientific depth.
The role will be pivotal in ensuring that medical excellence underpins all affiliate activities, while also representing Italy within Genmab's broader European and Global organizations.
Affiliate Partnership & Cross‑functional Collaboration
Serve as the strategic medical partner to the Italian General Manager, other cross functional partners, and the AIFA, AIOM, and regional oncology bodies to drive scientific engagement and access.
Ensure scientific and ethical rigor in all affiliate activities, collaborating effectively with Marketing, Market Access, Commercialization, Legal, QA, Regulatory, and other Research & Development and Enabling functions.
Establish and track clear medical performance metrics (KPIs) and ensure readiness for quarterly business reviews (QBRs) to drive accountability and continuous improvement.
Medical Strategy and Leadership
- Develop and oversee Italian Medical Affairs strategy in alignment with European and global medical affairs strategic plans.
- Act as the primary medical voice in Italy, ensuring that local insights inform national strategic priorities.
- Serve as a member of the European Medical Affairs Leadership Team and Italian Leadership Team contributing to the strategic direction & long‑term vision of the department.
- Collaborate closely with European Medical Affairs leadership and global strategy teams to provide the Italian perspective on opportunities, challenges, and stakeholder needs to ensure a consistent regional & global scientific narrative.
Scientific Communication & Evidence Generation
- Provide Italian medical/scientific perspective with targeted insight compilation, analysis to inform clinical development & commercialization planning.
- Oversee pan‑portfolio investigator interactions to enhance medical/scientific exchange & optimize study execution in Italy.
- Supervise dissemination & discussion of Genmab's scientific/clinical data with investigators and other appropriate HCPs.
- Develop and execute national conference plans, ensuring active participation in relevant professional society events.
- Enable externally sponsored Italian evidence generation initiatives.
External Engagement and Thought Leadership
- Build and sustain relationships with Italian top Key Opinion Leaders, healthcare and scientific communities, oncology networks, and scientific societies across Genmab's areas of interest.
- Represent Genmab at key local and regional medical congresses, symposia, and external scientific forums.
- Partner with patient advocacy and policy organizations to strengthen Genmab's presence as a trusted scientific collaborator.
- Collect, analyse, and integrate medical and external insights to guide strategy, inform decision‑making, and demonstrate the measurable impact of Medical Affairs in Italy.
Launch Leadership
- Partner cross functionally and drive launch readiness for the company's first and subsequent commercial launches, ensuring robust scientific engagement, medical education, and field readiness.
- Oversee launch readiness and lifecycle management across the region with evidence‑based, patient‑focused medical input.
- Lead the development and localization of medical materials, delivery of local advisory boards, and execution of congress strategies.
- Partner with MA Training to provide high‑quality scientific training and maintain exceptional standards of scientific/technical expertise.
Compliance & Governance
Drive the implementation and continuous strengthening of local medical governance frameworks to ensure full compliance and operational excellence.
Partner to ensure appropriate review and approval of promotional and non‑promotional materials to be used in Italy.
Collaborate with Pharmacovigilance and Regulatory Affairs to maintain product safety and compliance.
People and Team Development
Attract, develop, and retain top talent, fostering a culture of collaboration and excellence within the Italian organization, while aligning with Genmab's European values.
Provide mentorship and leadership to direct reports, drive superior performance, facilitate professional development, & cultivate future leadership talent ensuring their continuous development.
Champion innovation and direct change initiatives to benefit the business and enhance organizational effectiveness.
Exemplify Genmab's culture and values, working as One Team.
Qualifications & Experience
- MD, PharmD, or PhD in life sciences or a related discipline.
- 10+ years of experience in Medical Affairs within the pharmaceutical or biotech industry, with strong exposure to oncology.
- Strong knowledge of AIFA procedures, CTS/CPR evaluations, and Italian pricing and reimbursement pathways.
- Proven record of accomplishment of success in product launches and early affiliate development.
- Strong understanding of the Italian healthcare landscape, oncology ecosystem, and regulatory environment.
- Demonstrated ability to collaborate effectively within a matrix organization, balancing regional / global alignment and local execution.
- Fluent in Italian and English (written and spoken).
Competencies & Attributes
- Demonstrates strategic agility and innovative thinking, with the ability to operate effectively in a dynamic, high‑growth biotech environment while maintaining scientific and operational rigor.
- Strategic and analytical thinking with operational execution skills.
- Strong cross‑functional leadership.
- Excellent communication and stakeholder engagement skills.
- Deep scientific curiosity and a patient‑centric ethos.
About You
- You are genuinely passionate about our purpose.
- You bring precision and excellence to all that you do.
- You believe in our rooted‑in‑science approach to problem‑solving.
- You are a generous collaborator who can work in teams with a broad spectrum of backgrounds.
- You take pride in enabling the best work of others on the team.
- You can grapple with the unknown and be innovative.
- You have experience working in a fast‑growing, dynamic company (or a strong desire to).
- You work hard and are not afraid to have a little fun while you do so
Locations
Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work‑life balance.
Our offices are crafted as open, community‑based spaces that work to connect employees while being immersed in our powerful laboratories.
Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics.
For 25 years, its hard‑working, innovative and collaborative team has invented next‑generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T‑cell engagers, antibody‑drug conjugates, next‑generation immune checkpoint modulators and effector function‑enhanced antibodies.
By 2025, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock‑Your‑Socks‑Off (KYSO) antibody medicines.
Established in 1986, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific.
For more information, please visit Genmab.com.
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Head of Regulatory Affairs Italy
Solo per membri registrati Rome, Latium
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Head of Regulatory Affairs Italy
Solo per membri registrati Rome
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Head of Medical Affairs, Italy
Solo per membri registrati Roma, Lazio
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Head of Regulatory Affairs Italy
Solo per membri registrati Rome
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Head of Medical Affairs, Italy
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