Head of Clinical Affairs

5 maanden geleden

Amsterdam, Nederland SkinVision Voltijd

Company Overview:

SkinVision is a pioneering AI start-up on a mission to save 250k lives in the next decade by revolutionizing the early detection of skin cancer. Leveraging cutting-edge technology, our flagship product is a mobile app that employs AI to assess skin lesions and identify potential risks of skin cancer. We empower people to manage their skin health and enable an efficient connection between users and the health system. With over a million existing users and more than 30k new users joining us every month, we are constantly looking to grow our team with professionals who are driven by purpose and are challengers by nature.


Job Summary:

The Head of Clinical Affairs will lead and shape the clinical strategy and roadmap, ensuring the alignment of our product value with the clinical and economic needs of our customers. This role involves extensive interaction with key opinion leaders (KOLs), doctors, researchers, and end-users across the EU and USA. The successful candidate will oversee the planning and execution of clinical studies, ensuring compliance and excellence in all clinical research activities.


Key Responsibilities:

Clinical Strategy and Roadmap Development:

● Understand the healthcare landscape, including customers’ clinical and economic needs, and articulate the product value for our end-users.

● Assess the impact of proposed updates or new products on the clinical evidence strategy and drive the research roadmap definition for the next three years.

● Define the resource requirements and necessary expertise for the research team based on the research roadmap.

● Participate in strategic discussions with B2B partners to ensure the accuracy and alignment of clinical evidence.


Clinical Study Planning and Oversight:

● Develop and oversee Clinical Monitoring Plans and monitoring of clinical study sites. 

● Develop and negotiate study budgets, privacy agreements, and clinical trial contracts. 

● Oversee clinical studies, including database management, EC/CA submissions, and the preparation and execution of site trial training and investigator meetings.


Stakeholder Engagement and Relationship Building:

● Maintain contact and build relationships with KOLs, doctors, and researchers from medical centers.

● Collect feedback from potential end-users in the EU and the USA to inform clinical strategies and product development.



Qualifications:

● Advanced degree in a relevant field (e.g., Medicine, Life Sciences, Clinical Research). ● Minimum 10 years of experience in clinical affairs or clinical research, with significant experience in the medical device industry (preferably softwares).

● Extensive experience in clinical research and development within the healthcare or medical device industry.  

● Extensive knowledge of clinical trial processes and regulatory requirements: EU MDR, FDA, ISO 14155, ISO 13485, and GCP guidelines.

● Proven experience in leading and managing clinical research teams.

● Strong project management and organizational skills.

● Advanced analytical and problem-solving abilities.

● Proven ability to build and maintain relationships with KOLs, doctors, and researchers. ● Exceptional communication and negotiation skills.

● Experience with B2B partnerships and aligning clinical evidence with strategic goals. ● Fluency in English.

● Office tools and Google Workspace.


Preferred qualifications:

● Experience with database management and clinical data software.

● Previous experience in medical writing and scientific publication.

● Familiarity with regulatory submissions and EC/CA processes.

● Knowledge of skin cancer health economics; healthcare systems, market, and patient workflows.

● Fluency in other languages (Dutch and Spanish preferred).

● Technical Medicine or similar degree (in Dutch: technische geneeskunde).


What’s in for you:

● 3 office days per week with a healthy lunch and 2 days of working from home.

● Company laptop.

● A competitive salary based on your experience, a bonus structure and additional benefits (e.g. travel reimbursement and training budget).

● Join our enthusiastic and professional team with colleagues from all over the world. ● A dynamic and rapidly growing scale-up in Amsterdam.

● Unlimited skin checks for you, your family and your friends.

● Regular team events such as weekly drinks and monthly dinners.


Not sure if you are qualified?

Research shows that while men apply to jobs when they meet an average of 60% of the criteria, women tend to only apply when they check every box. If you feel energized by our mission and would like to use your first-class talent to accelerate the growth of SkinVision but don't necessarily meet every single point on the job description, please still apply. We'd love to receive your application and see if you could be a good fit.

  • Director International Regulatory Affairs Planning

    6 maanden geleden

    Amsterdam, Nederland Regeneron Pharmaceuticals Inc. Voltijd

    The Director of Planning and Strategy works in lockstep with the Head of International Regulatory Affairs to drive strategic planning and operations for the function, and to advance the objectives and vision of the Regulatory Leadership. This includes ensuring project support and oversight for complex programs in the region while also coordinating meeting...

  • Corporate Affairs Manager

    7 maanden geleden

    Amsterdam, Nederland Barilla Group Voltijd

    We are looking for our next Corporate Affairs Manager to join our Global Corporate Affairs Unit. The person will report to the Head of Global Corporate Affairs and will be based in our recently opened Headquarters in Amsterdam.  If you are keen to face new challenges, join a fast-paced company and start a new incredible professional journey, we are waiting...

  • Lead Clinical Content Strategist

    13 uur geleden

    Amsterdam, Noord-Holland, Nederland CSL Seqirus Voltijd

    Job SummaryWe are seeking a highly skilled Lead Clinical Content Strategist to join our team at CSL Seqirus. As a key member of our cross-functional clinical project teams, you will be responsible for planning, preparing, managing and coordinating medical writing projects for Clinical Development within R&D.About the RoleYou will be accountable for ensuring...

  • Head of Regulatory Affairs and Sustainability

    3 weken geleden

    Amsterdam-Zuidoost, Nederland Zaffra BV Voltijd

    **Functieomschrijving Hoofd Regulatory Affairs en Duurzaamheid** Zaffra is een onlangs opgerichte Joint Venture tussen wereldwijde partners, Sasol & Topsoe. De missie van Zaffra is om een toonaangevende producent en leverancier van duurzame vliegtuigbrandstof te worden. We investeren in en ontwikkelen projecten gedurende de hele levenscyclus, waarbij we...

  • Medical Affairs Strategist for Neurology and Psychiatry

    3 weken geleden

    Amsterdam, Noord-Holland, Nederland Teva Pharmaceuticals Voltijd

    About the OpportunityWe are seeking a seasoned Medical Affairs professional to join our team as a Medical Affairs Strategist for Neurology and Psychiatry. In this role, you will be responsible for developing and executing EU medical launch readiness plans for assigned products in neurology/psychiatry area.Your Key ResponsibilitiesDevelop and execute EU...

  • Clinical Trial Supply Manager

    3 maanden geleden

    Amsterdam, Nederland uniQure Voltijd

    **Clinical Trial Supply Manager** **Location**: - Amsterdam (Netherlands)**Education level**: - Bachelor / Graduate**Job category**: - Supply Chain**Target start date**: - 1/1/2025**Work Location**: - On-Site**Shift**: - 1st**Place in the Organization** The Clinical Trial Supply Manager will be part of a team based in Amsterdam, reporting to the Head...

  • Head of Compliance Emea

    2 maanden geleden

    Amsterdam, Nederland Flow Traders Voltijd

    Flow Traders is looking for a Head of Compliance for its EU operations. As EMEA Head of Compliance you will report into the Global Head of Compliance and the FTBV Chief Risk Officer and be directly responsible for all compliance efforts carried out by the compliance team based in Amsterdam and London. You will lead four direct reports that each own one of...

  • Head of Licensing and Regulatory Affairs

    2 maanden geleden

    Amsterdam, Nederland Adyen Voltijd

    **This is Adyen** Adyen provides payments, data, and financial products in a single solution for customers like Meta, Uber, H&M, and Microsoft - making us the financial technology platform of choice. At Adyen, everything we do is engineered for ambition. For our teams, we create an environment with opportunities for our people to succeed, backed by the...

  • Director - Public Affairs

    6 maanden geleden

    Amsterdam, Nederland Gilead Sciences Voltijd

    For Current Gilead Employees and Contractors: Please log onto your Internal Career Site At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies...

  • Regulatory Affairs Manager

    4 weken geleden

    Amsterdam, Nederland Rituals Voltijd

    Job DescriptionWe are seeking a knowledgeable and detail-oriented Regulatory Affairs Manager to join our Regulatory team. In this key role, you will ensure our products meet all global legislative requirements and standards while driving our compliance function to the next level. This is your opportunity to make a meaningful impact on the safety and...

  • Officer, Compliance

    5 maanden geleden

    Amsterdam, Nederland AXA Group Voltijd

    Officer, Compliance & Regulatory Affairs, Benelux We are now looking to add a Compliance Officer to our growing legal and compliance function based in Amsterdam, The Netherlands working with the Benelux region (with insurance business operations in The Netherlands and Belgium). In this role you will develop and drive our compliance function for this...

  • Humanitarian Affairs Manager

    5 maanden geleden

    Amsterdam, Nederland Artsen zonder Grenzen Voltijd

    Médecins Sans Frontières (MSF) is an independent medical humanitarian organisation that provides assistance to people worldwide, regardless of their background, religion or political convictions. Above all, we aim to save lives and to offer medical care to victims of disasters, wars and epidemics. Working together with local staff, we give direct support...

  • Internship - Global Government & Public Affairs

    2 maanden geleden

    Amsterdam, Nederland Heineken International B.V. Voltijd

    Internship - Global government & Public Affairs You will work alongside the Global Governmental and Public Affairs team, as well as with the local operating companies and colleagues from across the business. Tasks include: monitoring political developments, monitoring tax and/or regulatory developments that might get an impact on our industry, conducting...

  • Internship - Global Governmental & Public Affairs

    2 maanden geleden

    Amsterdam, Nederland Heineken International B.V. Voltijd

    Internship - Global Governmental & Public Affairs The internship You will work alongside the Global Governmental and Public Affairs team, as well as with the local operating companies and colleagues from across the business. Tasks include: monitoring political developments, monitoring tax and/or regulatory developments that might get an impact on our...

  • Director - Public Affairs

    7 maanden geleden

    Amsterdam, Nederland Gilead Sciences Netherlands BV Voltijd

    Description Director Public Affairs, BeNeLux Location: Netherlands Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with...

  • Head of Communications

    2 maanden geleden

    Amsterdam, Nederland Skytree Voltijd

    **WE ARE SKYTREE** Skytree enables a transition to a world with cleaner Air for everyone. We do this by developing and deploying smart technology that captures atmospheric carbon dioxide, enabling its use or storage to combat climate change and aid society and businesses around the world. Born out of the European Space Agency (ESA), we are a global team of...

  • Project Manager, Start-up

    6 maanden geleden

    Amsterdam, Nederland NLF Fortrea Netherlands BV Voltijd

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • In-house Clinician, Global Medical Devices

    4 maanden geleden

    Amsterdam, Nederland SGS Voltijd

    **Company Description** We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. As In-house Clinician,...

  • Associate Medical Director

    1 maand geleden

    Amsterdam, Nederland Teva Pharmaceuticals Voltijd

    The opportunityDevelopment and execution of EU medical launch readiness plan for assigned products in neurology/psychiatry area  Execution of all medical activities and projects for assigned neurology/psychiatry product(s)  Providing scientific/medical leadership, strategy and support for Teva assigned product(s) in neurology/psychiatry area.  Leading...

  • Head of Communications

    6 maanden geleden

    Amsterdam West, Nederland INHOPE - International Association of Internet Hotlines Voltijd

    **INHOPE Head of Communications** INHOPE is the global network of internet hotlines combatting online Child Sexual Abuse Material (CSAM). Our vision is a digital world free of CSAM and our mission is to support our Hotlines in combatting online CSAM. Hotlines provide the public with a way to anonymously report CSAM and other types of online illegal...