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Medical Director Netherlands

Amsterdam, Netherlands

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

  • Competitive compensation for your work
  • Emphasis on work/life balance
  • Collaborative and team-oriented environment
  • Opportunities for professional growth
  • Diversity and Inclusion
  • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

The Medical Director for the Netherlands leads the country medical department in the Netherlands. This includes taking medical scientific leadership and having the responsibility for pharmacovigilance, medical information, as well as the medical affairs support of pipeline and marketed products and pre-and post-approval development activities. As the scientific/medical ambassador for Sobi, the Medical Director will ensure that all activities in the country are carried out in an ethical and compliant manner. The Medical Director works in close collaboration with the Country Manager and Patient Access Manager, as well as the other colleagues of the cross-functional country team, and is an active member of the Medical Directors Leadership team.

This position is remote, but candidates must live in the Netherlands and be available for in-person team meetings (at least once per month) and other business-related meetings.

Scope and key responsibilities of the job:

  • Sobi spokesperson to external and internal stakeholders on medical and scientific and community engagement issues related to Sobi in-line and pipeline products
  • Leverages synergies across functions and TAs
  • Integrates medical and scientific and community engagement insights into affiliate and provides input to regional and global strategies , plans and tactics
  • Responsible for the recruitment, management, training and development of staff in the affiliate medical department
  • Plans and allocates affiliate medical department resources
  • Plans and is accountable for the affiliate medical and community engagement department goals, objectives and performance metrics
  • Responsible for the preparation of the affiliate medical and community engagement budget, the spending and the forecasting accuracy in close collaboration with the affiliate Country Manager
  • Responsible of the integration of affiliate medical perspective across TAs into international and global teams
  • Contributes to the affiliate portfolio life cycle management:
    • By maximizing Sobi’s value proposition of in-line and pipeline products through management and delivery of all medical and scientific and community engagement activities across TAs in the affiliate, guaranteeing that these are all conducted according to all relevant (local) regulations and SOPs
    • By actively supporting the commercial organisation to promote the scientific and medical value of Sobi products, and this in a compliant and ethical way
    • By supporting local patient access and reimbursement activities (communicates medical part of value proposition)
  • Supports local Sobi sponsored clinical research activities
  • Approval for medical accuracy of all local promotional and non-promotional materials and compliance documents with regards to commercial and non-commercial projects & interactions with HCPs/HCO/NMO/providers (incl consultancies, sponsorships, grants)
  • Ensure conduct of market research activities and patient support programs according to all relevant (local) regulations and SOPs
  • Ensure timely fullfilment of proper compliance and SOP training requirements and other educational requirements of medical staff
  • Responsible for the set-up and implementation of local Medical Information processes, in accordance with all relevant local and international regulations and requirements/SOPs
  • Pharmacovigilance key responsibilities as local responsible person:
    • Ensure global and local requirements are being met by implementing the necessary procedures at affiliate level, including process for reporting, translation and quality control of safety data
    • Ensure appropriate resources are available to manage PV locally, and determine set-up of a PV Hub if dedicated resources are required locally
    • Responsible for the quality of local translations of safety data from source documents
    • The following activities are delegated to the local PV Manager:
      • Oversight responsibility of local PV Hub, if available
      • As local contact person for Drug Safety, be contactable 24 hours a day, 7 days a week
      • Act as interface between EU-QPPV and local regulatory authorities as required
      • Secure the integrity and high standards in the handling of adverse events and risk management activities at local level, including for:
        • follow-up locally on adverse events/safety reports
        • responses to regulatory questions on patient safety matters in national language,
        • implementation  of local risk minimization activities
      • Ensure monitoring of local guidance and pharmacovigilance legislation including forwarding information to GPV, take the necessary actions at local level and implement the change within the set timelines to ensure local requirements are being met
      • Ensure that all local potential sources of safety information, including affiliate email inbox, websites, digital and social media forums, and customer relationship management system, are monitored every local business day
      • Ensure that local literature review is performed as per global and local requirements
      • Responsible for the transfer of safety data from source documents to other medium.
      • Ensure reconciliation of safety data between Sobi affiliate and other internal and external sources
      • Responsible for oversight of any vendor performing PV activities locally
      • Ensure PV related agreements (e.g. contracts with ESP, PSP providers, Market Research providers) include PV clauses.
      • Assist the timely closing of findings related to PV inspection/PV audits at local level
  • Manages affiliate Regulatory Affairs performance through local Regulatory Affairs consultant, supported by the Compliance/Quality manager and the PV manager
  • Responsible for the preparation, approval and distribution of local versions of Dear Health Care Professional letters or additional Risk Management Materials, possibly via delegation to designee
        • Provide support for (self-)audits and inspections at local level

Qualifications

Qualifications:

  • Education/Learning Experience/Work Experience
    • MD (preferably) or PhD (or other relevant education)
    • >8 Years of clinical development and medical affairs experience from a pharma- or biotech company, affiliate and/or HQ experience
    • Broad and formal leadership and people management experience
    • Advanced understanding of other functions including but not limited to Clin Ops/Commercial/Regulatory and Medical Affairs and Market Access
    • Finance/budgeting and resource management experience
    • Knowledge of local pharmaceutical industry and legal/health system environment
    • Knowledge of various therapeutic areas
    • Network of external stakeholders in different disciplines and TAs
  • Skills/Knowledge/Languages
    • Medical and scientific excellence
    • Excellent communication, presentation and negotiation skills
    • Analytical skills, strategic thinking
    • Track record of leadership and people management
    • Strong team-working ability
    • Continuously expanding medical and scientific knowledge as well as market knowledge
    • Broad skill set in Medical affairs, Clinical Development, Drug Safety, Regulatory Affairs and/or Market Access
    • In depth knowledge of pharmaceutical product development, product lifecycle management and commercialisation processes
    • In addition to local language (Dutch), excellent in English (speaking & writing)
  • Personal Attributes :
  • Strong customer orientation, science based and business acumen
  • High drive and accountability
  • Problem-solving and decision -making ability
  • Ability to multi-task and to operate efficiently and agile in a fast moving environment also when under pressure
  • Teamplayer
  • Strong personal integrity with ethical and compliant work attitude
  • Adhering to Sobi values (Ambition, Ownership, Urgency, Partnership, Care)

Work Hours and location

Full Time and majority home/field based with appropriate travel (national & international).

Additional Information

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us?

We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to florencia.mendez@sobi.com.

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