Background:

eu-LISA is the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA) manages large-scale IT systems to support the implementation of asylum, border management and migration policies in the European Union (EU). The Agency is also a front-runner for the digitalisation efforts of the EU's Justice and Home Affairs domain, building a new information architecture and contributing to the development of a new security ecosystem. Since the Agency's beginnings in 2012, eu-LISA has become the digital engine of the Schengen Area. With its activities and tasks, the Agency adds value to the EU Member States by supporting their efforts towards justice, security and freedom.

Task description:         

• Supports the Agency's Security Officers in developing and maintaining the security architecture of the agency in collaboration with the Enterprise Architect.
• The profile will be expected to perform the following tasks:
• Create and manage security standards, design patterns, and reference architectures
• Analyse and define security requirements for networks, corporate applications/systems , end user computing, mobility, and data center technologies and solutions
• Develop and maintain the organizational security control framework;
• Ensure that IT Security controls meet the requirements of all regulatory requirements or contractual requirements
• Work with the Security Officer and IT teams to ensure that implemented security technologies are integrated and fully utilized as intended in the protection of agency information systems.
• Monitoring and analysing trends in IT Security
• Develop strategic and detailed technical roadmaps of the enterprise security environments and the associated technologies required to deliver these solutions on a global basis.
• Develop the business, information and technical artifacts that constitute the enterprise information security architecture and solutions.
• Researches, evaluates, designs, tests, recommends and plans the implementation of new or updated information security technologies.

Education:       

• Minimum 4 years of relevant education (master or equivalent) after the secondary school

Minimum Experience:

• Minimum 6 years of relevant professional experience in IT security
• Minimum 4 years of professional experience in security architecture

Additional needed qualification, knowledge and skills:         

• Expected to possess advanced knowledge of/in:
• Core domains of IT Infrastructure such as Data Networks, Server and Desktop hardware and Operating Systems, Messaging, Collaboration, Storage and Backups, and related monitoring and management systems.
• Security-specific architecture methodology, e.g. SABSA
• Security architecture models, security strategy development, and compliance management.
• Mobile Architecture, Network and Application Security and/or Data protection
• Secure development processes.
• Application Security Vulnerabilities such as OWASP Top 10, CWE/SANS Top 25 and remediation approaches
• Cybersecurity control good practice such as the SANS Top 20 Critical Controls.
• IT audit/assessment frameworks: ISO-standards; NIST, CobiT and Industry standard application development methodologies
• Enterprise authentication authorization and identity management schemes (Active directory, LDAP, etc.)
• Technical security controls such as firewalls, IDS/IPS, Vulnerability Management, web application firewalls, security gateways, WiFi, Mobile security, DLP, public key infrastructure, Encryption and Authentication techniques,
• Relational Databases, Middleware Applications, Collaboration and Document management solutions.
• XML, Web Services and SOAP protocols, both in client and server as well as dynamic languages such as Objective-C, VBScript, JavaScript
• Network and web related protocols (TCP/IP, UDP, IPSEC, HTTP, HTTPS, SMTP, SNMP, ICAP, etc.)
• Expected to possess one or more of the following qualifications:
• Certified Information Systems Security Professional with Information Systems Security Architecture Professional concentration (CISSP-ISSAP)
• Certified Information Security Manager (CISM)
• Certified Information Systems Auditor (CISA)
• TOGAF certification
• Other similar credentials

The Opportunity:

The Senior Director, Commercial, France is responsible for defining and executing the local commercial strategy for oncology products. This role is accountable for building the commercial organization, driving launch and growth performance, and ensuring strong alignment across Medical Affairs, Market Access, and other key functions.

The incumbent needs to proactively recognize and address relevant systemic (e.g. health care structures, competitors, data gaps, diagnostic challenges, missing advocacy) and HCP related opportunities (e.g. therapeutic gaps, differentiation, economical attributes, clear messaging of patient- and physician relevant benefits). The Senior Director Commercial will further oversee the generation of insights from the therapeutic field, and translate these insights into a comprehensive, cross-functional strategy. Supporting a clear positioning and aligned communication approach, the incumbent will in addition secure the development and implementation of tactics and tools for the field force to effectively address customer needs.

Responsibilities:

• Act as the Commercial Lead for France accountable for local commercial strategy, execution, and performance across the oncology portfolio.

• Serve as a core member of the France Leadership Team, contributing France strategy, launch planning, and business decisions.

• Partner with regional and local Medical Affairs and Marketing Team to translate clinical and economic evidence into compelling value communications tailored for France stakeholders including HCPs and payers.

• Translate regional commercial strategy into locally optimized plans aligned with market dynamics, customer needs, and healthcare system requirements.

• Translate regional commercial strategy into locally optimized plans aligned with market dynamics, customer needs, and healthcare system requirements in close collaboration with the ED Marketing, Europe.

• Collaborate with regional commercial teams by representing the country and contributing to commercial plans shaping our strategy.

• Develop and execute country-level brand and portfolio strategies across pre-launch, launch, and post-launch phases.

• Drive demand generation and appropriate use through non-promotional and promotional channels in compliance with local regulations.

• Lead forecasting, budgeting, and operational planning for the country in close collaboration with the ED, Commercial Excellence, Business Analytics and Insights, Europe.

• Lead commercial launch readiness for oncology products, including customer strategy, segmentation, targeting, and field force planning.

• Partner closely with Medical Affairs and Market Access to ensure integrated launch execution and consistent external engagement.

• Monitor performance, competitive dynamics, and market trends, adjusting strategy as needed.

• Oversee customer engagement strategy across key stakeholders, including oncologists, treatment centers, and healthcare organizations.

• Ensure effective field force deployment and capability building (e.g., sales, key account management, customer-facing roles).

• Work closely with Medical Affairs, Market Access, Regulatory, Finance, Corporate Affairs and other support functions to ensure aligned and compliant country execution.

• Ensure strong integration of commercial plans with access, medical, and evidence strategies.

• Build, lead, and develop the country commercial organization, including sales, marketing, and customer-facing roles as the business scales.

• Establish commercial processes, governance, and ways of working as part of the country build-out.

• Foster a culture of accountability, collaboration, and performance excellence.

• Contribute to regional and country-specific initiatives.

• Travel nationally and internationally.

Required Skills, Experience and Education:

• Advanced degree required (e.g., MSc, PhD, MD, PharmD). 

• 10+ years of experience in pharmaceutical or biotech commercial roles.

• Significant experience in oncology commercial leadership at country level.

• Proven track record of successful oncology product launches in France and successful HCP / KOL interactions.

• Proven project management experience.

• Excellent communication skills, both in person and virtual.

• Scientific and solution-orientated mindset and capability to move and execute in a rapidly changing, ambiguous environment.

• Strong understanding of local healthcare systems, customer dynamics, and reimbursement environments.

• Experience in a US-based or global biotech and/or in a build-out or first-in-country role strongly preferred.

• Proven leadership and people management capabilities; demonstrated success in small but fast growing, entrepreneurial commercial environment.

• High capacity of social competence for teamwork, coaching and situational leadership.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.

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The Opportunity:

General Purpose 

The Senior Director, Head Pharmacist/Responsible Pharmacist guarantees the pharmaceutical responsibility of the laboratory as “exploitant” (see definition of the “exploitant”, Article R.5124-2, 3 ° of the French Public Health Code) and assumes the role of "Responsible Pharmacist" as described in Article R.5124-36 of the Public Health Code. Responsibilities include:

• Organize and supervise all pharmaceutical operations of the company or organization, including manufacturing, advertising, information, pharmacovigilance, batch monitoring and withdrawal, distribution, import and export of the drugs, products, objects or articles concerned, as well as the corresponding storage operations.

• Ensure that transport conditions guarantee the proper preservation, integrity and safety of these medicines, products, objects or articles.

• Acknowledge the files related to marketing authorization applications submitted by Corporate or organization and any other application related to the activities they organize and supervise.

• Participate in the development of research and study programs.

• Imperson authority over delegate and deputy pharmacists; approve their hiring and be consulted on their dismissal, except in the case of an army pharmacist-chemist.

• Appoint interim delegate pharmacists.

• Inform the other directors of the company or organization of any obstacle or limitation to the exercise of these powers.

• Implement all necessary means to comply with the obligations set out in articles R. 5124-48 and R. 5124-48-1;

• In the case of medicinal products intended to be marketed in the territory, he(she) ensures that the safety measures referred to in article R. 5121-138-1 have been affixed to the packaging in accordance with the conditions set out in articles R. 5121-138-1 to R. 5121-138-4;

• Notify the Agence nationale de sécurité du médicament et des produits de santé (ANSM : French National Agency for the Safety of Medicines and Health Products) of any launching on the national market of a medicinal product which is considered to be falsified within the provisions of article L. 5111-3, and for which they are responsible for the manufacture, exploitation and distribution.

They organize the quality system within the laboratory in accordance with French laws and regulations (good distribution practices, good pharmacovigilance practices, good manufacturing practices) and laboratory requirements.

They also support the transversal activities carried out by the marketing, medical, compliance and market access departments.

The Senior Director, Head Pharmacist/Responsible Pharmacist, France takes part in the deliberations of the management, administrative, executive or supervisory bodies, or those of any other body with an executive function, of the company or organization, when these deliberations concern or may affect the performance of the tasks falling under his/her responsibility as described above.

The RP is responsible for ensuring compliance with professional ethics and all regulations issued in the interests of public health. He/she must also ensure that the responsibilities of pharmacists and staff under his/her authority are clearly defined.

In accordance with articles L. 5121-14-3, R. 5121-152 and L. 5121-164 of the French Public Health Code, the RP ensures that pharmacovigilance cases are reviewed and processed within the appropriate timeframes.

In accordance with article L5121-9-2 of the French Public Health Code, the RP immediately informs the French National Agency for the Safety of Medicines and Health Products of any prohibition or restriction imposed by the competent authority of any country in which the medicinal product for human use is marketed, and of any other new information likely to influence the evaluation of the benefits and risks of the medicinal product for human use or the product concerned.

In addition, the Responsible Pharmacist also has knowledge of :

• the role of professional bodies and organizations that regulate those who supply medical products to the public.

• the ANSM's role in handling controlled drugs.

• the role of the European Medicines Agency (EMA) and the use of EUDRAGMDP.

• the Directive on Falsified Medicines.

• the principles and guidelines of good manufacturing practice, and how GMP/GDP principles maintain product quality throughout the distribution chain.

Responsibilities

In the performance of the duties, the Employee is responsible for the following tasks in French territory:

Regulatory Affairs:

• Submission and obtaining the opening authorization application for the “Exploitant” pharmaceutical establishment.

• Filling and submission of the annual facility master file (once a year).

• Relationships with the Health competent authority – the French Agency for the Safety of Medicines and Health Products (ANSM).

• Participation in the management of early access programs.

• Monitoring of drug marketing (declaration to the health authority of the date of initial marketing, reporting of prohibition or restriction decisions or any information likely to influence the benefit/risk assessment).

• Validation of the Advertising and Medical Information process.

• Participation in pharmaceutical document archiving management.

• Implementation of the Regulatory Intelligence process.

• Supervision of pharmaceutical contracts (head office and outsourced activities).

Quality Assurance/Supply Chain:

• Regular audits of internal pharmaceutical activities (distribution, medical information, promotion processes, claims, pharmacovigilance processes, etc.).

• Implementation of a risk management approach (document management, claims, audits, continuous improvement, premises, suppliers, shortages, etc.) and business continuity plan.

• Implementation of change control management process following regulatory approvals (marketing authorization, variations, risk management plan, etc.).

• Participation in audits and inspections by authorities (ANSM, etc.).

• Follow-up of batch release for distribution in France and tracking/traceability.

• Management of batch recalls with the marketing authorization holder, the health authority and distribution stakeholders.

• Management of shortages with the health authority.

• Storage and distribution management.

• Management of quality complaints.

• Implementation of procedures (SOP).

• Implementation of compliance with the French Charter of Promotional Information and its Guidance.

• Implementing quality compliance:

• Planning, execution and follow-up of audits.

• Implementation of KPIs (definition, collection and analysis of KPIs for key pharmaceutical activities).

Pharmacovigilance and drug safety management:

• Implementation of the local pharmacovigilance process.

• Nomination of local Qualified Persons responsible for Pharmacovigilance.

• Interaction with European Qualified Person responsible for Pharmacovigilance (QPPV); Global Patient Safety Department (GPS)and PV database.

• Procedures and data management.

• Report to Competent authorities.

• Collection, registration, assessment, report and follow-up of adverse events.

• Screening of local scientific and medical literature for pharmacovigilance relevant information.

• Local Signal detection.

• Review and validation of Periodic Safety Update Report (PSUR).

• Reconciliation of shared PV data.

• Implementation of key performance indicators (KPI).

• Monitoring of product good use and off-label use, and declaration to competent authorities if applicable.

Medical information management:

• Implementation of medical information process in collaboration with the Medical information department (data management, standard responses, access to literature database).

• Collection, registration and response to medical information requests.

• Reconciliation of shared medical information data.

• Implementation of KPI.

Advertising and promotional information:

Promotional and non-promotional material review and approval.

Review and submission to Health authority of promotional material.

Approval and dissemination of the positive list.

Logistical management of material with traceability (withdrawal, archiving, etc.).

Personnel training:

• Implementation of a local training process for pharmaceutical and compliance processes.

• Review and validation of training material for commercial and medical teams.

• Validation of integration and ongoing staff training plans, and monitoring of training plans.

• Ensuring that all staff are trained in Good Practices, their own tasks, product identification, risks of drug falsification and specific training for products requiring more rigorous handling.

• Competency assessment and empowerment of key personnel.

Participation to Compliance management:

• Participation to implementation of French law about anti-bribery, transparency and compliance of interaction with HCPs and HCOs.

• Participation to legal review of agreements with healthcare professionals, hospitals, organizations, etc.

Management of the Pharmaceutical Affairs Department in France

• Team leadership, development and management;

• Recruitment, training and development of team members;

• Follow-up of team objectives.

The above list of tasks is not exhaustive.

Required Skills, Experience and Education:

• Doctor in pharmacy and able to be registered as Responsible Pharmacist.

• Specialization in regulatory affairs and quality.

• Minimum 15 years of proven experience in leadership roles within the biopharmaceutical industry in the field of oncology.

• Fluency in both verbal and written French and English.

• Proven leadership and people management capabilities; demonstrated success in small but fast growing, entrepreneurial commercial environment.

• High capacity of social competence for teamwork, coaching and situational leadership.

• Proven track record shaping and executing country strategy and influencing policy at a senior industry level.

• In-depth knowledge of the French pharmaceutical market and regulatory environment.

• Ability to create and nurture a strong culture of collaboration and authenticity to extend and replicate the RevMed culture.

• Proven success in building effective relationships with internal stakeholders, regional authorities, and vendors.

• Highly organized and motivated individual possessing excellent communication, presentation and interpersonal skills.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

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The Opportunity:

Reporting to the VP, General Manager, France the Senior Director, Medical Affairs, France  is the medical leader responsible for defining and executing the local medical strategy for oncology products. This role serves as the medical voice within the French Leadership Team, ensuring scientific excellence, compliant medical engagement, and strong alignment between global strategy and local patient, physician, and healthcare system needs.

This leader will ensure that French medical considerations are embedded in the regional medical strategy and plans and will partner with the General Manager and crossfunctional teams, as well as the VP, Head of Europe Medical Affairs and their leadership team. The incumbent will contribute to building the French medical team and work closely with the Global and Regional Medical Affairs teams across Med Affairs functions.

Responsibilities:

• Act as the Medical Affairs lead for France, accountable for local medical strategy, execution, and impact across the oncology portfolio.

• Translate global medical and clinical strategies into locally relevant medical plans aligned with French regulations and clinical practice.

• Build and maintain strong relationships with national and regional key opinion leaders, oncology networks, academic institutions, and scientific societies.

• Lead scientific exchange, advisory boards, investigator and other external meetings, press conferences, and congress engagement at country level.

• Serve as medical expert within the local oncology and scientific community, acting as a spokesperson for France.

• Collaborate effectively with regional and global teams by contributing to overall medical affairs strategy, strongly partnering with local, regional and global clinical development and operations teams.

• Drive local medical strategy across pre-launch, launch, and post-launch phases.

• Provide local medical expertise on evidence generation activities including local studies, real-world evidence initiatives, and investigator-initiated research (where permitted).

• Ensure effective execution of publication plans and scientific communication activities.

• Lead medical launch readiness for oncology products, including training, scientific materials, and field medical engagement plans.

• Partner with Market Access and Commercial teams to support value communication and reimbursement-related interactions from a medical perspective, e.g. representing and defining evidence and value of innovation at oral HTA hearings.

• Support lifecycle management activities including new indications, label updates, and competitive positioning.

• Work closely with Market Access, Commercial, Regulatory, Safety, and Corporate Affairs teams to ensure aligned and compliant execution of country plans.

• Provide medical review and approval of non-promotional materials in accordance with local regulations and company policies.

• Build, lead, and develop the French Medical Affairs team, including Medical Directors and Medical Science Liaisons.

• Establish medical processes, governance, and ways of working as part of the french build-out.

• Foster a culture of scientific rigor, compliance, and collaboration.

• Ensure all medical activities comply with local regulations, national and EFPIA codes, and internal company policies.

• Represent Medical Affairs in french governance and risk management forums.

Required Skills, Experience and Education:

• Advanced degree required (MD, PhD, or PharmD).

• Strong background and experience in oncology required.

• 10+ years’ experience in Medical Affairs with a track record of country leadership.

• Proven value and benefit assessment experience, with deep understanding of country payer decision-making.

• Strong stakeholder management and ability to collaborate with internal and external partners.

• Proven experience supporting oncology product launches in a European market.

• Strong understanding of the local healthcare system, clinical practice, and regulatory environment.

• Experience in a US-based or global biotech and/or in a build-out or first-in-country role strongly.

• Excellent communication skills, both in person and virtual.

• Proven leadership and people management capabilities; demonstrated success in small but fast growing, entrepreneurial environment.

• Scientific and solution-orientated mindset and capability to move and execute in a rapidly changing, ambiguous environment.

• Strong understanding of local healthcare systems, customer dynamics, and reimbursement environments.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

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The Opportunity:

The Senior Director, Market Access is responsible for defining and executing the country market access strategy to ensure timely, sustainable patient access to innovative oncology therapies. This role shapes reimbursement and access strategy, drives value demonstration, and leads engagement with key external stakeholders including payers, HTA bodies, and health authorities.

This position will partner with commercial and medical affairs teams to deliver launch activities by providing access insights, developing evidence-based HTA, Pricing & Reimbursement dossiers and tools, engaging with market access and public affairs stakeholders as well as driving pricing strategy activities, and lead the activities to deliver access results supporting the overall success of the product launches.

Responsibilities:

• Lead Market Access & Reimbursement: Develop and implement strategies to support access and pricing decisions for oncology products within the France healthcare system.

• HTA & Pricing Filings: Lead preparation and submission of value dossiers, benefit assessments (e.g., AMNOG/G-BA, HAS, AIFA…) and pricing negotiations with statutory health insurance decision makers (e.g., GKV-SV, CEPS…).

• Partner with regional and local Medical Affairs and Marketing team to translate clinical and economic evidence into compelling value communications tailored for french payers.

• Build and maintain strong relationships with key external stakeholders (payers, HTA authorities, policy influencers). Representation of Revolution Medicines at local trade associations for market access subjects.

• Work with regional EU Market Access teams to align local access strategy with broader European and corporate objectives, especially in terms of aligning the European regulatory and JCA strategy and execution with local value dossier submission and pricing negotiation strategy. Provide early market access input to regional and EU clinical development and medical teams.

• Lead negotiation with all levels of national payers.

• Develop innovative pricing and value based contracting models to optimize the acceleration of reimbursement approvals.

• Policy Monitoring: Monitor health policy developments, HTA processes and local reimbursement environments to inform strategy.

• Represent Market Access in Country Leadership Team meetings and contribute to overall business strategy.

• Drive access and value related projects such as landscape assessments, payer market research, payer advisory boards and general guidance on local strategies.

• Development of outreach and engagement plan for key payers creating and maintaining a strong network.

• Create and lead a market access team, including coaching, performance management, and talent development when a team is in place.

• Early access planning of new products and indications, drive launch readiness for multiple oncology assets (portfolio responsibility).

• Influence EU / regional access strategy based on local payer insights from a leadership position

• Travel nationally and internationally.

Required Skills, Experience and Education:

• Advanced degree (e.g., Life Sciences, Pharmacy, Health Economics, Public Health).

• A minimum of 10 years’ experience in market access, pricing, reimbursement or health economics (Pharma/Biotech).

• Proven value and benefit assessment experience, with deep understanding of country payer decision-making.

• Demonstrated success and experience supporting oncology product pre-launch, launch and post launch in France.

• Demonstrated success in negotiating pricing and reimbursement conditions with public administrations and health authorities.

• Strong stakeholder management and ability to collaborate with internal and external partners.

• Excellent interpersonal and communication skills.

• Scientific and solution-orientated mindset and capability to move and execute in a rapidly changing, ambiguous environment.

• Strong understanding of local healthcare systems, customer dynamics, and reimbursement environments.

• Experience in a biotech and/or in a build-out or first-in-country role strongly preferred.

• Proven leadership and people management capabilities; demonstrated success in small but fast growing, entrepreneurial commercial environment.

• High capacity of social competence for teamwork, coaching and situational leadership.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

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What you’ll do

At Doctolib, we believe that technology and AI can help reinvent the work of healthcare professionals and improve people's health. To deliver increasing medical value to our users, we're embarking on our medical device certification journey - this is where you come in! 

As a QARA Program Manager at Doctolib, you will play a critical role in establishing and continuously improving our Quality Management System (QMS) to ensure compliance with medical device regulations. You'll work at the intersection of quality, regulatory affairs, and product development, enabling our teams to deliver safe, compliant, and innovative Software as a Medical Device (SaMD) solutions that transform healthcare.

Your responsibilities include but are not limited to:

Quality and Regulatory Compliance 

• Support gap and impact analyses between ISO 13485 and MDR 2017/745 requirements.
• Implement and maintain Doctolib's Quality Management System, including procedures, work instructions, templates, and regulatory documentation
• Configure and maintain our electronic Quality Management System (e-QMS), ensuring efficient document control, version management, and traceability
• Prepare and coordinate internal and external audits (certification bodies, notified bodies).
• Drive QMS adoption across cross-functional teams (Product, Tech, IT, HR, Procurement) through training, enablement, and stakeholder engagement.
• Lead the constitution of regulatory technical documentation to support CE marking and regulatory submissions.

Process & Risk Management

• Define and maintain comprehensive process maps, process descriptions, and associated risk analyses.
• Design and implement quality dashboards to monitor KPIs, process performance, and compliance metrics. 
• Lead continuous improvement initiatives based on data-driven insights and audit findings. 

Training & Enablement

• Design and deliver Quality and Regulatory training programs tailored to different functions and roles. 
• Foster a strong quality culture and regulatory awareness across the organization through workshops, communications, and hands-on support. 
• Serve as the go-to expert for quality and regulatory questions, providing practical guidance to teams. 

Regulatory Intelligence

• Conduct regulatory watch activities, with particular focus on AI/ML-specific standards, regulations, and guidance documents. 
• Assess the impact of regulatory changes on Doctolib's products and processes, proposing mitigation strategies. 

Cross-Functional Collaboration

• Partner closely with Tech, Product, Data Science, Medical Affairs, Legal, and Operations to embed quality and regulatory requirements into product development and business processes. 
• Act as a bridge between QARA and operational teams, translating regulatory requirements into actionable, practical guidance. 
• Support product teams throughout the software development lifecycle to ensure compliance from concept to post-market surveillance. 

Who you are

Before you read on — if you don't have the exact profile described below, but you feel this job description matches your skill set, we still encourage you to apply.

You could be our next team mate if: 

• You are fluent in English and French. 
• You bring at least 4-6 years of experience with Software as a Medical Device (SaMD) regulatory compliance, with a proven track record of participating in or leading CE marking processes for Class IIa devices and above.
• You have deep knowledge of medical device regulations and standards, particularly ISO 13485, MDR 2017/745, and the software development lifecycle standards IEC 62304 and IEC 82304. 
• You combine analytical thinking, structured problem-solving, and excellent project management skills to drive compliance initiatives across multiple stakeholders.
• You communicate with impact: You can translate regulatory complexity into clear, actionable guidance for non-regulatory audiences. 

What makes you successful in this role: 

• Drive and Autonomy: You are comfortable working independently, taking ownership of your projects with an entrepreneurial mindset. 
• Relationship building: You are a team player and proactively create connections with stakeholders across the organization. 
• Pragmatism: You know how to translate regulations into pragmatic, actionable guidance in a fast-moving, regulated environment.

Now, it would be fantastic if you:

• Are familiar with AI/ML-based medical devices and their specific regulatory considerations, including the EU AI Act and FDA guidance on AI/ML software.
• Speak German or Italian, a real plus as we continue to expand across Europe.

What we offer

• Free health insurance for you and your children
• Parent Care Program: receive one additional month of leave on top of the legal parental leave
• Free mental health and coaching services through our partner Moka.care
• For caregivers and workers with disabilities, a package including an adaptation of the remote policy, extra days off for medical reasons, and psychological support
• Work from abroad for up to 10 days per year thanks to our flexibility days policy
• Work Council subsidy to refund part of sport club membership or creative class
• Up to 14 days of RTT
• Lunch voucher with Swile card
• Reimbursement of public transportation 
• Relocation support for international mobilities
• Enrollment in Doctolib's long-term employee value sharing plan called DoctoGrowth

The interview process 

• Recruiter Interview (30’ remote)
• Hiring Manager Interview (1h remote)
• Business Case (1h onsite)
• Final Interview (45’ remote)
• At least one reference check

Job details

• Permanent position
• Full Time
• Workplace: Levallois-Perret (92, France)
• Start date: asap
• Compensation : fix + bonus on objectives (according to your profile)
• Partial remote allowed (2 days per week)

At Doctolib, we are committed to improving access to healthcare for everyone. This translates into our recruitment process. We evaluate candidates based solely on qualifications and motivation, without any form of discrimination.

The more diverse ideas are heard, the more our product will truly improve healthcare for all. You are welcome to apply to Doctolib, regardless of your gender, religion, age, sexual orientation, ethnicity, disability.

To ensure equal opportunities, we invite you to exclude personal information (e.g. pictures, age) from your applications. If you require any accommodation, please let us know for support during the hiring process. 

Join us in building the healthcare we all dream of!

All information provided is processed by Doctolib for application management. For data processing details, click here: Germany l France l Italy l Netherlands. Please contact hr.dataprivacy(at)doctolib.com to exercise your rights.

About BridgeBio Pharma, Inc. 

BridgeBio is a biopharmaceutical company dedicated to discovering, developing, and delivering transformative medicines for patients living with genetic diseases and genetically defined cancers. Since our founding in 2015, we have built a diverse portfolio of more than 20 drug development programs, ranging from early discovery to late-stage clinical trials, across multiple therapeutic areas including precision oncology, cardiology, endocrinology, neurology, and renal disease. We have already achieved regulatory approval for three therapies and continue to advance promising science from academia into meaningful treatments for patients worldwide. 

Who We Are 

BridgeBio is a global biotechnology company with our Global Headquarters located in San Francisco, USA, and our International HQ located in Zug, Switzerland. Since establishing our European presence in 2021, we’ve been building empowered, high-performing teams across countries — with experienced colleagues who move quickly, take ownership, and are fueling the company’s international growth. 

At BridgeBio, you’ll find an energetic and collaborative culture where pragmatism meets bold decision-making. We embrace uncertainty with confidence, guided by our commitment to making a meaningful impact for patients. Our people are trusted and empowered, united by urgency, purpose, and the drive to advance science for patients around the world. 

To learn more about our story and company culture, visit us at https://bridgebio.com

What You'll Do

You will report to the General Manager, Western Europe Region and work closely with Market Access, Commercial locally and regional, global Medical Affairs to drive strategic initiatives that support BridgeBio’s mission of delivering transformative medicines to patients with genetic diseases and genetically driven cancers. 

Your primary purpose will be to set up and lead our Medical Affairs team, develop and oversee execution of our regional medical affairs plan from early pre-launch through post-launch, ensure medical and scientific education of HCPs as part of our launch efforts, and support market access-related work as a key stakeholder. You will also be a core member of the extended International Medical Affairs team, bringing the voice of the country to the international discussion and decision-making process. 

You will be part of the Region leadership team, this role requires effective collaboration with cross-functional colleagues and external stakeholders to ensure high-quality execution and impact. The ideal candidate combines deep expertise in medical and scientific engagement in the context of introducing a biotech for the first time to KOLs, and making a remarkable contribution to a disease space in pre-launch and launch phase in a rare disease and orphan conditions. We look for strong scientific acumen, patients’ driven mindset, communication skills, adaptability, and the ability to thrive in a fast-paced, hands-on environment. 

Responsibilities

• Develop and execute the WEU Medical Affairs plan, defining clear priorities and objectives to advance best clinical practice and support company goals, delivered on time and fully aligned with global strategy
• Create and develop a strong relationship with the medical community, patients groups and external stakeholders, to be identified as the key Medical trusted expert in the region
• Build, lead, and develop a high-performing Medical Affairs team, ensuring delivery of objectives, continuous capability development, and effective use of standardized tools, templates, and ways of working, high engagement scores, and achievement of agreed medical KPIs
• Lead pre-launch medical readiness, including disease state education, unmet need articulation, initiatives to significantly improve diagnosis rates, and structured scientific exchange planning and KOL engagement, resulting in defined launch readiness milestones
• Design and deliver insight-generation and medical education activities, including advisory boards, congress symposia, standalone meetings, hospital-based education, and speaker development programs, with measurable impact on insight quality, scientific exchange effectiveness, and stakeholder satisfaction
• Drive operational excellence across Medical Affairs by ensuring effective communication, performance management, and robust documentation of activities and insights through fit-for-purpose reporting systems, KPIs, and metrics, demonstrated by timely, high-quality reporting, actionable insights, and audit-ready documentation
• Identify, prioritize, and execute high-impact medical research initiatives aligned with business objectives, including BridgeBio-sponsored and investigator-initiated studies, in close collaboration with Global Clinical and R&D teams, resulting in approved study plans, on-time study initiation, and generation of locally relevant data
• Leverage AI and digital technologies to enhance medical insights generation, stakeholder engagement, knowledge management, and operational efficiency, ensuring compliant, ethical, and value-driven use of emerging digital solutions, with demonstrable improvements in insight capture, efficiency, and scalability of medical activities

The above job description documents the general nature and level of work but is not intended to be an exhaustive list of activities, duties, and responsibilities required of job incumbents. Therefore, job incumbents are expected to perform all other duties as assigned or required, as training and experience allow. 

Where You'll Work

This is a France-based role with a strong customer facing component. We anticipate travel within France as a priority country for KOL meetings and speaker program attendance, Belgium, the Netherlands (and Switzerland for internal alignment and engagement at our international office in Zug) and European travel for conferences and medical events. Local team meetings and designated office location in France is Paris. 

Who You Are

• MD, PharmD, or PhD is required
• Minimum 7-9 years of experience within Biotech/Pharma in Medical Affairs roles of increasing responsibilities
• Pre-and post-product launch experience in complex situations, rare diseases and orphan conditions in the respective national markets
• Fluent in written and verbal French and English
• A minimum of 2-3 years of people management experience
• You lead by example, attract and develop talents, build interdependent partnerships, and create a culture of collaboration and teamwork that fosters open communication, constructive conflict resolution, and organizational flexibility
• Regular travel (25-50%) is required to build KOL relationships and represent the company at medical conferences, presentations, and other meetings
• Highly accountable and self-disciplined leader with a sense of responsibility and ownership of projects and products

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.  

• Market leading compensation 
• Hybrid work model - we value your flexibility in how you work, but encourage time in the office to strengthen our culture, collaboration, and sense of community
• We provide career development through regular feedback, continuous education and professional development programs
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
  
  

As part of the Commercial organization, this role plays a key role in driving the marketing strategy and execution for innovative cardiovascular therapies across France & Benelux. Reporting to the Head of Commercial France & Benelux, the position combines strategic contribution with strong operational leadership to support successful product launches and sustainable brand growth.

The role works in close partnership with cross-functional teams including Medical Affairs, Regulatory, Market Access, and Sales, as well as with Global and Regional Marketing counterparts. The incumbent contributes to the adaptation and evolution of brand strategy, ensures effective omnichannel execution, and supports business performance while maintaining full compliance with internal and external requirements.

Key Responsibilities

• Lead the development, adaptation, and delivery of local marketing strategies and plans in alignment with global and regional brand frameworks.
• Contribute to the evolution of brand positioning, value propositions, and lifecycle priorities by integrating local market insights, competitive intelligence, and customer needs.
• Build and steer comprehensive pre-launch, launch and post-launch plans, ensuring cross-functional alignment, planning and execution readiness.
• Translate scientific and clinical data into clear, compelling, and differentiated customer narratives.
• Drive omnichannel engagement initiatives to effectively engage healthcare professionals through digital platforms, congresses, and face-to-face interactions.
• Partner with Sales leadership to support field force enablement, including training on brand strategy, campaigns, and tools.
• Lead market research activities and competitive analysis to inform both tactical decisions and forward-looking planning.
• Act as a key partner to Medical Affairs, Regulatory, Market Access, and Sales teams to ensure integrated, compliant brand execution.
• Serve as a primary interface with Global and Regional Marketing teams, providing local market input and contributing to broader strategic discussions.
• Manage relationships with external agencies, media partners, and event organizers to ensure high-quality delivery aligned with brand objectives.
• Plan and oversee the company’s participation in national and regional congresses, symposia, and educational initiatives.
• Own and manage marketing budgets and financial processes in line with strategic and operational priorities.
• Monitor brand performance, launch progress, and key business risks, providing regular updates to local and EU stakeholders.
• Ensure compliance with company SOPs, promotional codes, and applicable regulations, while supporting continuous improvement of marketing processes and ways of working.
• Provide leadership and direction to marketing resources and extended cross-functional contributors to drive accountability and performance.
• Contribute to the definition of operational priorities and resourcing to support business objectives.
• Support the development of marketing capabilities, best practices, and cross-functional collaboration within the affiliate.

Qualifications & Experience

• Bachelor’s degree in science, pharmacy, or medical science; an advanced degree in marketing, business administration, or a related field is preferred.
• Significant experience in pharmaceutical marketing, omnichannel strategy, or related commercial roles, including leadership of country-level launches.
• Experience in cardiovascular and/or specialty products, ideally within competitive or innovative therapeutic areas.
• Strong scientific acumen with the ability to translate complex clinical data into impactful marketing strategies.
• Solid understanding of laws, regulations, and codes governing communication with healthcare professionals.
• Demonstrated project management experience with strong planning, prioritization, and cross-functional coordination skills.
• Experience working with external agencies and partners (digital, media, events, congresses).
• Excellent interpersonal, communication, and presentation skills.
• Fluency in French and English.

Key Competencies

• Strategic and analytical thinking combined with a hands-on, execution-oriented approach.
• Strong leadership presence with the ability to influence and collaborate across functions and levels.
• Ability to operate effectively in complex and evolving environments.
• High level of organizational rigor and ability to manage multiple priorities.
• Clear and concise communication skills, with the ability to convey complex information effectively.
  
  #LI-ONSITE

What you’ll do

We are looking for a Senior Staff Machine Learning Engineer to join the Clinical team in the AI and Machine Learning Department. You'll lead the technical direction of AI systems that enhance clinical decision-making and patient care. You'll tackle the hardest problems in healthcare AI, from building voice-powered consultation assistants to establishing LLM evaluation frameworks that ensure clinical safety and efficacy. This role combines deep R&D with strategic technical leadership, shaping how Doctolib deploys AI in regulated healthcare environments.

Your responsibilities include but are not limited to:

Technical Strategy & Architecture

• Own the long-term technical roadmap for clinical ML systems, from model architecture selection to production deployment patterns
• Drive strategic build vs. buy decisions, balancing custom development with foundation model APIs
• Define standards for safe rollout in healthcare contexts: shadow testing, staged deployment, and human-in-the-loop workflows

End-to-End ML Delivery

• Lead design and implementation of LLM-powered clinical agents (consultation summarization, clinical coding, evidence-grounded recommendations)
• Establish rigorous evaluation frameworks using real-world clinical datasets, ensuring outputs meet clinical accuracy and safety standards
• Build production infrastructure: model and prompt versioning, guardrails, uncertainty quantification, cost optimization, and observability
• Define a bold strategy for online and offline performance objectives to reach new levels of healthcare professionals satisfaction

Leadership & Impact

• Mentor Staff or Senior ML Engineers and Applied Scientists, elevating technical standards across the organization
• Lead cross-functional initiatives spanning Product, Medical Affairs, Legal, and Compliance teams
• Translate clinical needs into research questions and production systems that measurably improve patient outcomes
• Partner with our medical, legal, and compliance teams to meet EU regulatory expectations (e.g., GDPR, MDR, upcoming EU AI Act) and market standards.

Who you are

Before you read on,  if you don't have the exact profile described below, but you feel this job description matches your skill set, we still encourage you to apply.

• You have 10+ years in ML/AI with 3+ years at Staff+ or Principal level leading complex, multi-team technical initiatives
• You have a PhD in Computer Science, AI, Statistics, or related field (or equivalent research experience)
• You have deep expertise in at least two of: clinical NLP, LLM fine-tuning and evaluation, automatic speech recognition, RAG systems, or reinforcement learning
• You are expert in Python, PyTorch/Transformers for training, vLLM/similar for inference with a track record deploying ML systems in production (AWS/GCP)
• You have exceptional communication skills and are able to align diverse stakeholders and explain complex technical decisions

Now it would be fantastic if you have:

• Publications in top-tier ML/AI conferences (NeurIPS, ICLR, ACL) or medical informatics venues
• Experience with EU healthcare regulations (GDPR, MDR, AI Act)
• Prior work with clinical data or healthcare applications

What we offer

• Free comprehensive health insurance for you and your children
• Parent Care Program: receive one additional month of leave on top of the legal parental leave
• Free mental health and coaching services through our partner Moka.care
• For caregivers and workers with disabilities, a package including an adaptation of the remote policy, extra days off for medical reasons, and psychological support
• Work from abroad for up to 10 days per year thanks to our flexibility days policy
• Work Council subsidy to refund part of sport club membership or creative class
• Up to 14 days of RTT
• A subsidy from the work council to refund part of the membership to a sport club or a creative class
• Lunch voucher with Swile card

The interview process

• HR Screen
• Hiring Manager Interview
• Behavioral Interview
• Technical Questions 
• Technical Case Study
• At least one reference check

Job details

• Permanent position
• Full-time
• Hybrid work mode (3 days/week in the office)
• Paris, France
• Start date: as soon as possible

If you would like to find out more about tech life at Doctolib, feel free to read our latest Medium blog articles!

At Doctolib, we are committed to improving access to healthcare for everyone. This translates into our recruitment process. We evaluate candidates based solely on qualifications and motivation, without any form of discrimination.

The more diverse ideas are heard, the more our product will truly improve healthcare for all. You are welcome to apply to Doctolib, regardless of your gender, religion, age, sexual orientation, ethnicity, disability.

To ensure equal opportunities, we invite you to exclude personal information (e.g. pictures, age) from your applications. If you require any accommodation, please let us know for support during the hiring process.

Join us in building the healthcare we all dream of!

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