The Opportunity:

RevMed is seeking an experienced privacy executive to support RevMed’s business.  The Executive Director, Global Privacy will lead the strategy, development, and execution of the company’s Privacy Program, ensuring all activities are conducted ethically and in accordance with applicable laws, regulations, and industry codes. This attorney will be instrumental in shaping and sustaining a culture of integrity as the company advances and commercializes its oncology pipeline.

The Executive Director, Global Privacy is a senior leader responsible for driving the organization’s global privacy strategy, governance, and compliance framework. This role ensures that all business activities involving personal data are conducted ethically and in compliance with applicable international laws, regulations, and industry standards.

Reporting to the Vice President, Compliance, this role serves as a key advisor to the General Counsel (GC) and other senior executives on global privacy, data protection, and responsible data use, while fostering a culture of privacy-by-design across all business functions worldwide.

The position can be based in the US or Switzerland.

Key responsibilities include:

Strategic Leadership & Governance

• Lead the development and execution of a comprehensive global privacy strategy aligned with business objectives and the broader compliance program.

• Serve as a senior advisor to the General Counsel (GC) and other senior executives on global privacy risks, regulatory developments, and data governance.

• Establish and maintain enterprise-wide global privacy governance frameworks, policies, and standards.

• Design the Global Privacy team structure and operating model leveraging both regional and global resources, support design and implementation of technology-enabled systems and processes for regional adaptation where appropriate and recruit a high-performing team.

• Provide regular updates to the General Counsel and other senior executives on global privacy program performance, risks, and mitigation strategies.

Global Privacy Program Management

• Design, implement, and continuously enhance a global privacy program aligned with international laws and best practices.

• Ensure alignment of the privacy program with the company’s overall compliance framework and enterprise risk management approach.

• Ensure compliance with global privacy and data protection regulations, including GDPR, UK GDPR, HIPAA, CCPA/CPRA, and other applicable international and local laws.

• Oversee Data Privacy Impact Assessments (DPIAs), cross-border data transfer mechanisms, and global risk assessments.

• Monitor and report on privacy metrics, trends, and program effectiveness across regions.

Clinical and Commercialization Data-Driven Activities

• Serve as the primary privacy lead for all clinical trial-related activities, including data collected from clinical sites, investigators, and patients.

• Partner with R&D and clinical teams to ensure compliant handling of sensitive clinical and health data.

• Collaborate with Commercialization teams to advise on processes, controls, and risks related to data-driven activities, including analytics, digital initiatives, and commercialization strategies.

Operational Integration

• Embed privacy-by-design and privacy-by-default principles into systems, products, and business processes globally.

• Partner cross-functionally with Compliance, Legal, IT Security, R&D, HR, and Commercial teams across regions.

• Support global initiatives involving sensitive data, including clinical, digital, and analytics-driven programs.

• Work closely with HR and Information Security (IS) to address employee and internal data privacy matters, including monitoring, investigations, and governance of workforce data.

Risk Management, Investigations & Incident Response

• Lead or oversee global privacy incident response, including breach assessment, notification, and remediation across jurisdictions.

• Lead and/or oversee privacy-related investigations, including internal reviews and regulatory-driven inquiries.

• Collaborate with Compliance and Information Security to ensure consistent global controls and preparedness.

• Identify, assess, and mitigate global privacy risks in alignment with enterprise risk management priorities.

Regulatory & External Engagement, Third-party & Contractual Oversight

• Serve as a key point of contact for global data protection authorities and regulators, in coordination with Compliance and Legal.

• Support global regulatory inquiries, audits, and inspections related to privacy.

• Oversee global privacy due diligence and risk management for third-party vendors and partners.

• Own and maintain privacy-related standards across the organization, including templates and playbooks.

• Review, negotiate, or oversee negotiation of privacy and data protection terms in contracts, including data processing agreements (DPAs), standard contractual clauses (SCCs), and related provisions.

• Ensure consistent and appropriate privacy language across all contractual forms and third-party engagements.

Training, Culture & Awareness

• Develop and deliver global privacy training and awareness programs aligned with compliance initiatives.

• Promote a culture of privacy, ethics, and accountability across all geographies.

• Partner with Compliance to integrate privacy into Code of Conduct, global policies, and enterprise training programs.

Required Skills, Experience and Education:

• Juris Doctor (JD); active bar membership a plus.

• Privacy certifications (e.g., CIPP/E, CIPP/US, CIPM, CIPT).

• 15+ years of experience in privacy, data protection, legal, compliance, or risk management

• Significant experience managing or leading global privacy programs in multi-jurisdictional environments.

• Experience in regulated industries (e.g., biotech, pharmaceutical, healthcare, or technology) preferred.

• Deep knowledge of global privacy regulations and frameworks (e.g., GDPR, UK GDPR, HIPAA, CCPA/CPRA, and other international laws).

• Experience with cross-border data transfers, data localization requirements, and global data governance.

• Strong understanding of privacy risk assessments, data lifecycle management, and compliance program integration.

• Familiarity with emerging areas such as AI/ML governance, digital health, and global data strategy.

• Ability to influence senior leadership and drive global, cross-functional initiatives.

• Strong strategic thinking with practical, business-oriented judgment.

• Excellent communication and stakeholder management skills across diverse geographies.

• Proven ability to lead teams and operate effectively in a matrixed, global organization.

• Strong organizational and project management capabilities.

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. 

#LI-Hybrid #LI-LO1

The Opportunity:

RevMed is seeking an experienced privacy executive to support RevMed’s business.  The Executive Director, Global Privacy will lead the strategy, development, and execution of the company’s Privacy Program, ensuring all activities are conducted ethically and in accordance with applicable laws, regulations, and industry codes. This attorney will be instrumental in shaping and sustaining a culture of integrity as the company advances and commercializes its oncology pipeline.

The Executive Director, Global Privacy is a senior leader responsible for driving the organization’s global privacy strategy, governance, and compliance framework. This role ensures that all business activities involving personal data are conducted ethically and in compliance with applicable international laws, regulations, and industry standards.

Reporting to the Vice President, Compliance, this role serves as a key advisor to the General Counsel (GC) and other senior executives on global privacy, data protection, and responsible data use, while fostering a culture of privacy-by-design across all business functions worldwide.

The position can be based in the US or Switzerland.

Key responsibilities include:

Strategic Leadership & Governance

• Lead the development and execution of a comprehensive global privacy strategy aligned with business objectives and the broader compliance program.

• Serve as a senior advisor to the General Counsel (GC) and other senior executives on global privacy risks, regulatory developments, and data governance.

• Establish and maintain enterprise-wide global privacy governance frameworks, policies, and standards.

• Design the Global Privacy team structure and operating model leveraging both regional and global resources, support design and implementation of technology-enabled systems and processes for regional adaptation where appropriate and recruit a high-performing team.

• Provide regular updates to the General Counsel and other senior executives on global privacy program performance, risks, and mitigation strategies.

Global Privacy Program Management

• Design, implement, and continuously enhance a global privacy program aligned with international laws and best practices.

• Ensure alignment of the privacy program with the company’s overall compliance framework and enterprise risk management approach.

• Ensure compliance with global privacy and data protection regulations, including GDPR, UK GDPR, HIPAA, CCPA/CPRA, and other applicable international and local laws.

• Oversee Data Privacy Impact Assessments (DPIAs), cross-border data transfer mechanisms, and global risk assessments.

• Monitor and report on privacy metrics, trends, and program effectiveness across regions.

Clinical and Commercialization Data-Driven Activities

• Serve as the primary privacy lead for all clinical trial-related activities, including data collected from clinical sites, investigators, and patients.

• Partner with R&D and clinical teams to ensure compliant handling of sensitive clinical and health data.

• Collaborate with Commercialization teams to advise on processes, controls, and risks related to data-driven activities, including analytics, digital initiatives, and commercialization strategies.

Operational Integration

• Embed privacy-by-design and privacy-by-default principles into systems, products, and business processes globally.

• Partner cross-functionally with Compliance, Legal, IT Security, R&D, HR, and Commercial teams across regions.

• Support global initiatives involving sensitive data, including clinical, digital, and analytics-driven programs.

• Work closely with HR and Information Security (IS) to address employee and internal data privacy matters, including monitoring, investigations, and governance of workforce data.

Risk Management, Investigations & Incident Response

• Lead or oversee global privacy incident response, including breach assessment, notification, and remediation across jurisdictions.

• Lead and/or oversee privacy-related investigations, including internal reviews and regulatory-driven inquiries.

• Collaborate with Compliance and Information Security to ensure consistent global controls and preparedness.

• Identify, assess, and mitigate global privacy risks in alignment with enterprise risk management priorities.

Regulatory & External Engagement, Third-party & Contractual Oversight

• Serve as a key point of contact for global data protection authorities and regulators, in coordination with Compliance and Legal.

• Support global regulatory inquiries, audits, and inspections related to privacy.

• Oversee global privacy due diligence and risk management for third-party vendors and partners.

• Own and maintain privacy-related standards across the organization, including templates and playbooks.

• Review, negotiate, or oversee negotiation of privacy and data protection terms in contracts, including data processing agreements (DPAs), standard contractual clauses (SCCs), and related provisions.

• Ensure consistent and appropriate privacy language across all contractual forms and third-party engagements.

Training, Culture & Awareness

• Develop and deliver global privacy training and awareness programs aligned with compliance initiatives.

• Promote a culture of privacy, ethics, and accountability across all geographies.

• Partner with Compliance to integrate privacy into Code of Conduct, global policies, and enterprise training programs.

Required Skills, Experience and Education:

• Juris Doctor (JD); active bar membership a plus.

• Privacy certifications (e.g., CIPP/E, CIPP/US, CIPM, CIPT).

• 15+ years of experience in privacy, data protection, legal, compliance, or risk management

• Significant experience managing or leading global privacy programs in multi-jurisdictional environments.

• Experience in regulated industries (e.g., biotech, pharmaceutical, healthcare, or technology) preferred.

• Deep knowledge of global privacy regulations and frameworks (e.g., GDPR, UK GDPR, HIPAA, CCPA/CPRA, and other international laws).

• Experience with cross-border data transfers, data localization requirements, and global data governance.

• Strong understanding of privacy risk assessments, data lifecycle management, and compliance program integration.

• Familiarity with emerging areas such as AI/ML governance, digital health, and global data strategy.

• Ability to influence senior leadership and drive global, cross-functional initiatives.

• Strong strategic thinking with practical, business-oriented judgment.

• Excellent communication and stakeholder management skills across diverse geographies.

• Proven ability to lead teams and operate effectively in a matrixed, global organization.

• Strong organizational and project management capabilities.

#LI-Hybrid  #LI-YG1

The Opportunity:

Reporting to the VP, GM, Midsized Markets, the Senior Director, Medical Affairs, Midsize Markets Europe, is the medical leader responsible for defining and executing the medical strategy for oncology products in our portfolio within Midsized markets. This role serves as the medical voice within the Midsized markets 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 Midsized markets medical considerations are embedded in the regional medical strategy and plans and will partner with the Midsized markets country managers and crossfunctional teams, as well as VP Head of Europe Medical Affairs and their leadership team. The incumbent will contribute to building the Midsized markets medical team and working closely with the Global, Regional, Country Medical Affairs teams across Med Affairs functions.

Responsibilities:

• Act as the Medical lead for Midsized Markets, accountable for medical strategy, execution, and impact across the RevMed portfolio.

• Serve as a core member of the Midsized Markets Leadership Team, contributing insights to medical and clinical development strategy, launch planning, and business decisions.

• Establish Midsized markets medical strategy across pre-launch, launch, and post-launch phases.

• Oversee all aspects of medical strategy and execution in Midsized markets.

• Cross-functionally align efforts seamlessly with access, regulatory, and commercial objectives while building and executing upon the medical plan.

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

• Translate global medical and clinical strategies into relevant medical strategy.

• Represent the company as the senior medical expert within the local oncology and scientific community, acting as a spokesperson for Midsized markets.

• Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions.

• Build strong relationships with national 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.

• Provide medical leadership 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 country and regional 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.

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

• Help recruit country Medical teams, including Medical Directors and Medical Science Liaisons.

• Establish medical processes, governance, and ways of working as part of the Midsized markets 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 Midsized markets Medical Affairs in company governance and risk management forums.

Required Skills, Experience and Education:

• Advanced degree required (MD or PhD).

• Strong background and experience in oncology required.

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

• Experience with scientific data generation, clinical trial interpretation, and communication of complex data to diverse audiences.

• Proven value and benefit assessment experience, with deep understanding of midsized markets access, local healthcare systems and regulatory landscape.

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

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

• Experience in biotech.

• Excellent communication skills, both in person and virtual.

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

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

• 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 environment.

• Highly organized and motivated individual possessing excellent communication, presentation and interpersonal skills. Thrives in a fast-paced, dynamic small company environment and able to adjust priorities and workload based upon changing needs.

• Willingness to travel nationally and internationally.

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. 

#LI-Remote #LI-LO1

The Opportunity:

The Associate Director, Regulatory Operations, Europe will play a key role in supporting the growing European Regulatory Affairs organization by leading the operational planning and execution of regulatory submissions across the region. This role partners closely with the European Regulatory Affairs team to operationalize regional regulatory strategies and ensure successful execution of regulatory submissions to health authorities across the EU, EEA, UK and Switzerland.

Working cross-functionally with regulatory strategy, clinical, CMC, nonclinical, and quality teams, the Associate Director will drive submission planning, manage regulatory documentation, and coordinate cross-functional teams to deliver high-quality submissions in accordance with global and regional regulatory operations processes and systems. While primarily focused on the European region, this role operates within Global Regulatory Operations and may support regulatory submissions in other regions as business needs evolve.

Primary Responsibilities:

• Serve as the primary Regulatory Operations partner supporting the European Regulatory Affairs team to execute regional regulatory strategies.

• Lead operational planning, preparation, publishing, and submission of regulatory dossiers to European health authorities including EMA, EU/EEA national authorities, MHRA, and Swissmedic.

• Lead regulatory submission planning and operational execution for major regulatory applications including Marketing Authorisation Applications (MAA), ensuring effective coordination of submission timelines, dossier assembly, publishing, and submission readiness.

• Develop and manage detailed regulatory submission timelines, proactively driving cross-functional teams to ensure timely preparation, review, and delivery of submission components.

• Coordinate cross-functional activities required for regulatory submissions, including document preparation, review cycles, and final submission readiness.

• Publish and perform quality control of regulatory submissions in eCTD format using DocuBridge, ensuring compliance with applicable regulatory technical requirements.

• Manage regulatory submission content and metadata within Veeva Vault RIM, ensuring accuracy and completeness of regulatory information and documentation.

• Support preparation and coordination of key regulatory deliverables including Clinical Trial Applications (CTA), scientific advice packages, pediatric plans, and lifecycle management submissions.

• Provide operational guidance to cross-functional teams regarding submission requirements, document standards, and regulatory timelines.

• Partner with Global Regulatory Operations to ensure alignment of regional submission processes, systems, and regulatory documentation standards.

• Manage external publishing vendors and consultants supporting regulatory submission activities.

• Provide regulatory operations support for global submissions as needed, collaborating with Global Regulatory Operations colleagues across regions.

• Manage regulatory procedures via EMA IRIS platform, including scientific advice, orphan designation, and other applicable EMA interactions.

• Ensure accuracy, completeness, and consistency of structured regulatory data and metadata across Veeva Vault RIM and European health authority systems (e.g., CTIS, IRIS, eSubmission Gateway).

• Coordinate submission activities across multiple European submission channels and platforms, ensuring alignment of dossier content and data across eCTD and portal-based submissions.

• Lead operational support for EU regulatory lifecycle activities, including variations, renewals, and other post-approval submissions, ensuring compliance with EU procedural requirements.

Required Skills, Experience and Education:

• Bachelor’s degree in life sciences or related discipline.

• 8+ years of experience in regulatory operations, regulatory affairs, or regulatory submission management within the biotechnology or pharmaceutical industry.

• Demonstrated experience preparing and publishing eCTD submissions to global health authorities.

• Strong understanding of European regulatory submission requirements and procedures.

• Hands-on experience using Veeva Vault RIM for regulatory information management.

• Hands-on experience using DocuBridge for regulatory publishing.

• Demonstrated ability to lead regulatory submission timelines and coordinate cross-functional submission deliverables.

• Strong understanding of regulatory document management, publishing standards, and regulatory submission lifecycle processes.

• Proven ability to manage multiple complex regulatory submissions simultaneously while maintaining high quality and compliance.

• Strong organizational, communication, and stakeholder management skills.

• Familiarity with EMA IRIS platform and associated regulatory procedures (e.g., scientific advice, orphan designation).

• Experience managing regulatory data, metadata, and submission tracking across multiple health authority systems and platforms.

Preferred Skills:

• Experience supporting regulatory submissions to European health authorities including EMA, MHRA, Swissmedic, or EU national competent authorities.

• Experience supporting Marketing Authorisation Applications (MAA) or other major marketing applications.

• Experience working in global regulatory teams supporting both regional and global regulatory submissions.

• Oncology or rare disease regulatory experience is considered an advantage.

• Experience managing regulatory publishing vendors or external regulatory consultants.

• Experience working within a growing or evolving regulatory organization.

• Experience navigating EU regulatory procedures (centralised, decentralised, or mutual recognition).

• Familiarity with evolving EU regulatory data standards (e.g., SPOR/IDMP) is a plus.

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. 

#LI-Hybrid #LI-LO1

The Opportunity:

As part of our expanding European organization, we seek a strategic and hands-on Director, CMC Regulatory, Europe who will be responsible for developing and executing regional CMC regulatory strategies to support early development, marketing authorizations, and lifecycle management across Europe.

This role is responsible for ensuring successful interactions with the European Medicines Agency (EMA), national competent authorities (NCAs), and other regional regulatory bodies. It provides leadership across early- and late-stage CMC regulatory activities, including clinical trial applications, initial marketing authorization applications (MAA), post-approval variations, and lifecycle strategy.

The position requires deep expertise in EU regulatory frameworks, strong cross-functional collaboration, and the ability to proactively identify and manage regulatory risks while supporting business objectives.

Primary Responsibilities:

• Provide CMC regulatory support for clinical trial applications and regulatory interactions, ensuring alignment with EU requirements and timelines.

• Develop and lead execution of European CMC regulatory strategies to support initial marketing authorizations and lifecycle management of the company’s product portfolio.

• Oversee preparation, review, and submission of high-quality CMC dossiers for EU MAAs, variations, renewals, and line extensions.

• Serve as the primary CMC regulatory lead for Europe, managing interactions with EMA, NCAs, and other European regulatory bodies.

• Provide strategic input into global regulatory strategies, ensuring alignment while addressing EU-specific requirements and expectations.

• Assess regulatory impact of CMC changes and provide proactive, risk-based guidance to ensure compliance with EU regulations.

• Interpret and apply EU regulatory requirements (EMA, ICH, EU GMP, and national guidance) to support efficient regulatory pathways, ensure compliance, and proactively monitor and communicate evolving regulatory expectations across functions.

• Anticipate regulatory risks and develop mitigation strategies aligned with European approval timelines.

• Partner with global Regulatory Affairs, Quality, Technical Operations, and external partners to ensure consistent and compliant execution of submissions.

• Represent CMC regulatory on European or global cross-functional teams, ensuring alignment between global strategy and regional execution.

• Provide leadership, mentorship, and technical guidance to team members and contribute to building regional CMC regulatory expertise.

• Oversee external vendors and CROs to ensure timely, high-quality regulatory submissions and approvals.

Required Skills, Experience and Education:

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline. An advanced degree (PhD, PharmD, MSc) is desirable.

• Minimum of 15 years of experience in pharmaceutical/biotech drug development, including at least 5 years in CMC regulatory affairs with European focus.

• Strong expertise in EU CMC regulatory requirements, including MAAs, variations, and lifecycle management.

• Direct hands-on experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities

• Demonstrated experience supporting EMA submissions and interactions.

• Deep knowledge of EU GMP regulations and ICH guidelines, with ability to apply across the product lifecycle.

• Experience with small molecules (NCEs) and managing complex CMC technical documentation.

• Proven ability to lead regulatory strategy for European approvals within global development programs.

• Strong leadership and project management skills with ability to manage multiple complex programs.

• Excellent communication and stakeholder management skills, including experience working cross-functionally and with external partners.

• Ability to operate effectively in a fast-paced, matrixed, global environment.

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. 

#LI-Remote #LI-LO1

At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

Reporting to the Executive Director, Regulatory Affairs - CMC, the Director of Regulatory Affairs-CMC is responsible for leading regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international regulatory submission strategies.

Responsibilities

• Formulate CMC regulatory strategies, without supervisor oversight, based on current regulatory intelligence.
• Collaborates with cross-functional project teams and external business partners to develop CMC regulatory strategies and identify regulatory risks; represents the department in cross-functional project teams.
• Identifies the required documentation and any content, quality and timeline issues for global submissions and manages the delivery of approved technical documents in accordance with project timelines.
• Manages the preparation, authoring and maintenance of regulatory submission documents pertaining to CMC data for global clinical trial and marketing applications, as well as post-marketing variations. May require technical regulatory authoring of submission package components.
• Supports the evaluation of manufacturing changes for the potential impact on products.
• Provides expert review of CMC documentation supporting regulatory submissions and communications.
• Coordinates preparation of responses to queries from regulatory authorities, particularly focused on CMC. May require technical regulatory authoring to support responses to queries.
• Maintains knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs.
• Ensures conformance to commitments made with various regulatory agencies (e.g., IND/CTA commitments) for assigned programs.
• Provides regulatory advice to other functional areas.
• May participate in regulatory due diligence activities.

Relationships

• Build and maintain collaborative relationships with internal/external business partners to achieve project regulatory goals.
• Develops and maintains collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelines.
• Develop and manage relationships with external vendors and regulatory health authorities.
• Coordinates activities for meetings and conferences with FDA, EMA, and other regulatory authorities
• Collaborate with regulatory colleagues to provide CMC expertise as needed.

Management

• This is an Individual Contributor position; however, there is the possibility for supervising consultants/contractors and/or interns.
• Develops and implements regulatory operating guidelines and common work practices/strategies within the team.

Qualifications

• 10 - 12+ years of related work experience (Director candidates will typically bring 12+ years; Associate level candidates may be considered with 10+ years and strong potential), including 8+ years in Regulatory Affairs CMC in the Biotech/Pharmaceutical industry; experience in small molecule drug development required; experience in the cardiovascular therapeutic area is a plus
• Proven experience serving as a primary RA-CMC contact to Health Authorities, with full strategic responsibility.
• Bachelor’s degree is required, preferably in chemistry or a closely related field; advanced degree is a plus.
• Advanced degree is preferred.
• Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
• Solid working knowledge of core processes associated with discovery, development, and manufacturing of small molecules.
• Experience with eCTD requirements and electronic submissions
• Experience with international regulatory submissions and processes is a strong plus.
• Ability to work effectively across teams, functions and with outside partners.
• Excellent oral and written communication skills
• Excellent organizational skills and attention to detail

#LI-HYBRID

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs. 

Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, and has operations in Basel, Switzerland.

Purpose/Summary: The Clinical Operations Lead owns program delivery & operational CRO/vendors oversight oof one or more development programs.

The Clinical Operations Lead has hands-on accountability and responsibilities in overseeing clinical trials execution within the program(s), especially the oversight of the trials/Program CRO, consultants and contractors to secure excellence in the delivery of their services to meet the trial milestones while adhering to quality, timeline, and budget. Leads by example with strong partnering and communication capabilities.

Key responsibilities:

• Takes a lead role in managing clinical program(s) and collaborating globally and across departments such as clinical development, regulatory, data management, biostatistics, drug supply, medical writing, and drug safety, etc.
• Supports creation and maintenance of the clinical development plan in collaboration with the Clinical Development Lead by providing input on operational aspects of the program and trials, including, but not limited to, budget, timelines, and vendors.
• Oversees CTT performance, including metrics, milestones and compliance with relevant regulatory standards, including ICH‑GCP, protocol requirements and company procedures.
• Collaborates with the Global Clinical Trial Managers (gCTM) and functions in the following activities, among others:
  • Support decision-making in the selection of study
  • oversight of CROs, vendors, consultants and contractors, including negotiation of Scope of work (SOW), ensuring delivery against contracted SOW, budgets, performance management and issue
  • Development and management of program timelines, budgets and
  • Oversight of trial subject retention
• Constantly scans for possible risks and implementation of mitigations; while identifying best practices and opportunities for trial efficiencies and opportunities for enhanced quality.
• Leads by example, onboarding, coaching, and mentoring other Development Operations team members, , fostering a team culture of ownership, engagement, and continuous improvement, ensuring recognition of team successes.
• Provides immediate supervision and line management to one or more employees, , including employee development, company goal setting, and performance management processes.
• Contributes to strategic vision and long-term plans of Development
• Supports in determining the best utilization and prioritization of resources, and the optimal organization of infrastructure and staff, leveraging experience working in varying resource models (i.e. Hiring, Functional Service Provider, CRO Full Package Outsourcing, etc.).
• Identifies and eliminates any impediments that obstruct or distract the team from delivering value; report and escalate issues, concerns, and roadblocks to management as needed.
• Regularly interacts with senior management on matters concerning functional areas and/or vendors.
• Contributes with the development and implementation of policies and standard operating procedures (SOPs) to be used in Development Operations
• Other duties as assigned

Prerequisite Education, Experience, & Skills:

• A highly motivated and results-oriented leader with a Bachelor’s degree and 14 years of pharmaceutical/Biotech clinical development and operations experience.
• Broad experience in global level clinical trial management, and knowledge of principles and practices of Program and Project Management. 
• Significant experience managing all aspects of activities in Phase I-IV trials, oversight of CROs and vendors at global level.
• Advantageous to have rare disease trial experience.
• Proven ability to effectively manage a large team comprised of permanent employees, consultants, contractors and oversight/partnering with CROs and teams within their varying levels.
• Intense drive and organizational expertise are necessary to manage the diverse group of functional activities involved in the international clinical trials program.
• Strong proficiency in GCP/ICH, U.S. drug development process and regulatory expectations related to global clinical trials execution .
• Excellent interpersonal, oral, and written communication skills.
• Ability to drive high-level decision-making, think strategically, and take initiative in the face of incomplete information
• Able to motivate teams to do their best work through active collaboration, healthy debate, and continued learning.

Are you a fluent French-speaking medicine expert eager to shape the future of AI? Large‑scale language models are evolving from clever chatbots into powerful engines of scientific discovery. With high‑quality training data, tomorrow’s AI can democratize world‑class education, keep pace with cutting‑edge research, and streamline clinical work for healthcare professionals everywhere. That training data begins with you—we need your expertise to help power the next generation of AI.

We’re looking for medicine specialists who live and breathe internal medicine, pharmacology, pathology, clinical diagnostics, medical ethics, human physiology, epidemiology, immunology, and evidence-based medicine. You’ll challenge advanced language models on topics like differential diagnosis, drug interactions, treatment protocols, pathophysiological mechanisms, clinical trial design, public health interventions, and diagnostic imaging interpretation—documenting every failure mode so we can harden model reasoning.

On a typical day, you will converse with the model on clinical scenarios and theoretical medical questions, verify factual accuracy and logical soundness, capture reproducible error traces, and suggest improvements to our prompt engineering and evaluation metrics.

A medical degree (MD, DO) or a master’s/PhD in a health sciences field is ideal; clinical experience, peer‑reviewed publications, hospital-based practice, or public health project involvement signal fit. Clear, metacognitive communication—“showing your work”—is essential. Fluency in French is required.

Ready to turn your medicine expertise into the knowledge base for tomorrow’s AI? Apply today and start teaching the model that will teach the world.

We offer a pay range of $8-to- $65 per hour, with the exact rate determined after evaluating your experience, expertise, and geographic location. Final offer amounts may vary from the pay range listed above. As a contractor you’ll supply a secure computer and high‑speed internet; company‑sponsored benefits such as health insurance and PTO do not apply.

Job title: Master - Medicine Specialist (Fluent in French) – AI Trainer
Employment type: Contract
Workplace type: Remote
Seniority level: Mid‑Senior Level

Your role:

• Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
• Write Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
• Manages the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution
• Provide project updates to project management team.
• Organize delivery of investigational product, laboratory supplies, CRFs and other study specific materials to and from the clinical sites.
• Perform investigational product inventory and ensure return of unused investigational product to designated location or verify destruction as required.
• Assists with, prepare for, and attends Investigator Meetings for assigned studies.
• Review study documents for compliance with protocol, ICH GCP guidelines, Protocol Deviations/Violations and Waivers, review study documents for subject safety events; escalate issues at site to project management.
• Collect and review essential study documents from site for filing in eTMF.
• Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluates quality and integrity of study site practices related to the proper conduct of the study and ensure adherence to applicable regulations.
• Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Participates in the planning of quality assurance activities and coordinates resolution of audit findings.
• Assists the Clinical Trial Manager with clinical operations activities by overseeing resource allocation, reviewing site performance, providing feedback to CRAs and CTAs, resolving issues, performing review and oversight of site visit reports.
• May review protocols, eCRFs, study manuals and other study related documents, as requested by the Clinical Trial Manager.
• May conduct on-site evaluation visits and on-site training of CRAs
• Lead and partake in regular team meeting / teleconferences.
• Assist, as appropriate, with reporting site performance regarding timelines and deliverables during project team meetings and assist with providing and compiling feedback for analysis of overall study performance.
• May serve as mentor to associates on the subject of job performance, trainings and professional growth.
• Other duties as assigned. 

Your Profile:

• Bachelor’s Degree in biomedical sciences or related scientific discipline
• Fluent English (oral and written) and applicable local business language.
• Minimum three years of monitoring experience
• Sound knowledge of medical terminology and advanced proficiency in clinical monitoring process.
• Ability to travel up to 70%, depending on project requirements.
• Good knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
• Good leadership, planning, project management skills, verbal communication skills, and written communication skills
• Knowledge and experience with MS Office suite (at a minimum Word, PowerPoint and Excel).

If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com or email us at careers@biorasi.com.