Synchron Inc.
San Diego, California
Job Description Job Description About Synchron Synchron's vision is to build non-surgical brain-computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time. In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems. Senior Director, Regulatory Affairs Location: San Diego, California (Onsite) Department: Regulatory Reports to: VP, Regulatory and Quality About the Role We are seeking a Senior Director of Regulatory Affairs will serve as the senior regulatory leader for Synchron's San Diego operations, providing strategic and operational oversight across software, firmware, and hardware regulatory activities. This role will own regulatory strategy for new BCI platform development, with oversight of ongoing product updates, and manufacturing-related submissions, working closely with cross-functional teams in engineering, quality, and clinical to ensure regulatory readiness at every stage of the product lifecycle. Key Responsibilities Regulatory Strategy and Submissions Lead regulatory strategy and submission planning for software, firmware, and hardware for new product development programs and product updates Author and manage IDE, PMA, and PMA supplement submissions to the FDA; support additional international filings as needed Develop and execute software and firmware regulatory strategy for complex BCI devices, including AI/ML considerations, software and firmware change management, and lifecycle documentation in compliance with applicable guidance Provide regulatory support for manufacturing-related activities, including process changes and design transfers Cross-Functional Leadership Partner with engineering, software, quality, clinical, and operations teams to integrate regulatory requirements from early development through commercialization Provide regulatory guidance on new product concepts, design inputs, and technology transfers Support project planning and roadmaps with well-defined regulatory milestones and risk assessments Regulatory Intelligence and Compliance Monitor evolving FDA regulations, guidance documents, and international standards relevant to Class III implantable devices and complex software- and firmware-driven medical technologies Ensure ongoing compliance with IDE and approved submission commitments, including reporting obligations and correspondence management Represent Synchron in FDA meetings, pre-submission interactions, and agency correspondence Minimal travel expected ( Perform other duties and responsibilities as assigned Required Qualifications Bachelor's degree in engineering, life sciences, or a related field; advanced degree preferred. 12+ years of regulatory affairs experience in the medical device industry, with progressive responsibility including demonstrated experience with complex, high-risk (Class III) active implantable neurological or cardiac devices. Strong software and firmware regulatory expertise for complex medical devices, including experience with AI/ML-enabled features, software and firmware change management, and applicable FDA guidance Track record of leading FDA submissions (IDE, PMA, supplements) and managing agency interactions independently Familiarity with manufacturing-related regulatory considerations, including process changes and design transfers, in a device development or scale-up context Experience supporting new product development from concept through submission, including design control and risk management integration Deep knowledge of 21 CFR Parts 820, 812, 814, and applicable international standards Exceptional written and verbal communication skills; ability to translate regulatory complexity for engineering and executive audiences Effective time management and interpersonal skills Builds productive internal and external working relationships Preferred Qualifications RAC certification (RAPS) Experience with brain-computer interfaces, neural stimulation, or implantable neurotechnology Familiarity with OUS regulatory pathways (CE Mark, TGA, or similar) Experience scaling a regulatory function at a growth-stage medical device company Key Competencies Strong attention to detail and commitment to accuracy Excellent problem solving Effective written and verbal communication Ability to partner cross functionally and influence stakeholders Strong organizational and project management skills, with comfort operating in a lean, startup style environment Compensation The base salary range for this role is $210,000 - $240,000 depending on experience, skills, and qualifications. In addition to base salary, this role may be eligible for discretionary bonuses and/or equity grants , subject to board approval and company policy. Visa Sponsorship We are unable to offer visa sponsorship for this position currently. Benefits (for W-2, full-time, exempt employees in the US only) Intern positions not eligible Subsidized medical and dental insurance coverage for you and your dependent(s) Life insurance, short-term disability, long-term disability 401k Discretionary unlimited PTO Flexible Spending Account for you and your dependent(s), with eligible plan elections Commuter benefits for NY employees Equal Employment Opportunity (EEO) Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. If you need a reasonable accommodation during the application or interview process, please let us know. Join Us At Synchron, you will be part of a transformative mission and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply now and build the future with us.
Job Description Job Description About Synchron Synchron's vision is to build non-surgical brain-computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time. In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems. Senior Director, Regulatory Affairs Location: San Diego, California (Onsite) Department: Regulatory Reports to: VP, Regulatory and Quality About the Role We are seeking a Senior Director of Regulatory Affairs will serve as the senior regulatory leader for Synchron's San Diego operations, providing strategic and operational oversight across software, firmware, and hardware regulatory activities. This role will own regulatory strategy for new BCI platform development, with oversight of ongoing product updates, and manufacturing-related submissions, working closely with cross-functional teams in engineering, quality, and clinical to ensure regulatory readiness at every stage of the product lifecycle. Key Responsibilities Regulatory Strategy and Submissions Lead regulatory strategy and submission planning for software, firmware, and hardware for new product development programs and product updates Author and manage IDE, PMA, and PMA supplement submissions to the FDA; support additional international filings as needed Develop and execute software and firmware regulatory strategy for complex BCI devices, including AI/ML considerations, software and firmware change management, and lifecycle documentation in compliance with applicable guidance Provide regulatory support for manufacturing-related activities, including process changes and design transfers Cross-Functional Leadership Partner with engineering, software, quality, clinical, and operations teams to integrate regulatory requirements from early development through commercialization Provide regulatory guidance on new product concepts, design inputs, and technology transfers Support project planning and roadmaps with well-defined regulatory milestones and risk assessments Regulatory Intelligence and Compliance Monitor evolving FDA regulations, guidance documents, and international standards relevant to Class III implantable devices and complex software- and firmware-driven medical technologies Ensure ongoing compliance with IDE and approved submission commitments, including reporting obligations and correspondence management Represent Synchron in FDA meetings, pre-submission interactions, and agency correspondence Minimal travel expected ( Perform other duties and responsibilities as assigned Required Qualifications Bachelor's degree in engineering, life sciences, or a related field; advanced degree preferred. 12+ years of regulatory affairs experience in the medical device industry, with progressive responsibility including demonstrated experience with complex, high-risk (Class III) active implantable neurological or cardiac devices. Strong software and firmware regulatory expertise for complex medical devices, including experience with AI/ML-enabled features, software and firmware change management, and applicable FDA guidance Track record of leading FDA submissions (IDE, PMA, supplements) and managing agency interactions independently Familiarity with manufacturing-related regulatory considerations, including process changes and design transfers, in a device development or scale-up context Experience supporting new product development from concept through submission, including design control and risk management integration Deep knowledge of 21 CFR Parts 820, 812, 814, and applicable international standards Exceptional written and verbal communication skills; ability to translate regulatory complexity for engineering and executive audiences Effective time management and interpersonal skills Builds productive internal and external working relationships Preferred Qualifications RAC certification (RAPS) Experience with brain-computer interfaces, neural stimulation, or implantable neurotechnology Familiarity with OUS regulatory pathways (CE Mark, TGA, or similar) Experience scaling a regulatory function at a growth-stage medical device company Key Competencies Strong attention to detail and commitment to accuracy Excellent problem solving Effective written and verbal communication Ability to partner cross functionally and influence stakeholders Strong organizational and project management skills, with comfort operating in a lean, startup style environment Compensation The base salary range for this role is $210,000 - $240,000 depending on experience, skills, and qualifications. In addition to base salary, this role may be eligible for discretionary bonuses and/or equity grants , subject to board approval and company policy. Visa Sponsorship We are unable to offer visa sponsorship for this position currently. Benefits (for W-2, full-time, exempt employees in the US only) Intern positions not eligible Subsidized medical and dental insurance coverage for you and your dependent(s) Life insurance, short-term disability, long-term disability 401k Discretionary unlimited PTO Flexible Spending Account for you and your dependent(s), with eligible plan elections Commuter benefits for NY employees Equal Employment Opportunity (EEO) Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. If you need a reasonable accommodation during the application or interview process, please let us know. Join Us At Synchron, you will be part of a transformative mission and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply now and build the future with us.
Clinical Dynamix, Inc.
San Diego, California
Remote opportunity but candidate must be in Southern CA area! Position Summary: The Associate Director, Competitive Intelligence is responsible for generating timely, objective, and actionable competitive intelligence that supports informed decision-making across the organization. Working collaboratively with cross-functional partners, this individual will monitor the evolving external landscape, synthesize complex scientific and business information, and deliver high-quality intelligence products that enhance organizational awareness of the competitive environment. This role is focused on competitive intelligence, strategic analysis, congress intelligence, knowledge management, and external landscape monitoring across Companys portfolio and therapeutic areas of interest. The successful candidate is scientifically curious, analytical, and proactive, with the ability to identify meaningful developments, distinguish signal from noise, and communicate relevant insights clearly and concisely. Responsibilities : Monitor the external environment for scientific, clinical, regulatory, commercial, financial, partnership, and competitive developments relevant to Companys portfolio and therapeutic areas of interest. Develop and maintain competitive landscape assessments, competitor profiles, asset summaries, clinical trial trackers, timelines, and other intelligence resources. Proactively identify and communicate significant competitive developments, emerging trends, and industry changes to relevant stakeholders. Gather, evaluate, and synthesize information from scientific literature, clinical trial databases, regulatory agencies, congress presentations, company disclosures, investor communications, and other publicly available sources. Prepare concise competitive intelligence reports, presentations, executive summaries, trackers, and recurring updates tailored to a variety of internal audiences. Lead planning, coordination, and execution of competitive intelligence activities for major scientific and medical congresses, including pre-congress planning, intelligence collection, and post-congress analyses. Maintain competitive intelligence repositories, monitoring systems, and knowledge management resources to ensure information is organized, current, and readily accessible. Partner with Commercial, Medical Affairs, Regulatory Affairs, Clinical Development, Research, and other cross-functional teams to understand evolving intelligence needs and provide timely support. Respond to ad hoc competitive intelligence requests by conducting focused research and preparing objective summaries and analyses. Support cross-functional planning discussions by providing objective, evidence-based intelligence on competitor activity, external trends, and therapeutic landscape evolution. Continuously improve competitive intelligence processes, workflows, templates, and reporting practices to increase efficiency, consistency, and impact. Evaluate and incorporate emerging technologies, including AI-enabled tools, to enhance intelligence gathering, synthesis, monitoring, and knowledge management. Manage relationships with external intelligence vendors, consultants, and information providers, as appropriate. Ensure all competitive intelligence activities are conducted in accordance with company policies, legal requirements, and industry ethical standards. Perform other duties as assigned. Education/Experience Requirements: Bachelors degree in Life Sciences or a related discipline; advanced degree such as PhD, PharmD, MD, MS, or MBA preferred. Equivalent combination of education and applicable job experience may be considered. At least 8 years of relevant experience in biotechnology, pharmaceuticals, life sciences consulting, competitive intelligence, scientific strategy, medical strategy, commercial strategy, or related functions. Additional Skills/Experience Requirements: The ideal candidate will embody Companys core values: Courage, Community Spirit, Patient Focus and Teamwork. Strong understanding of drug development, clinical research, regulatory pathways, commercialization, and the biotechnology industry. Demonstrated ability to efficiently gather, evaluate, and synthesize information from diverse scientific, clinical, regulatory, commercial, and business sources into clear, concise, and relevant insights. Experience independently leading competitive intelligence projects, managing multiple workstreams, and delivering high-quality outputs under time-sensitive conditions. Excellent analytical, written, verbal, presentation, and organizational skills. Ability to communicate complex scientific and business information clearly to cross-functional stakeholders. Ability to manage multiple priorities while working independently and collaboratively in a fast-paced environment. Demonstrated scientific curiosity, sound judgment, attention to detail, and a proactive approach to problem-solving. Organized, adaptable, detail-oriented, and able to prioritize information based on business relevance. Ability to travel domestically and internationally up to 10%, including attendance at scientific and medical congresses, professional meetings, and occasional company meetings. All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote. Preferred Skills/Experience: Experience in rare disease, nephrology, rare metabolic diseases, or specialty pharmaceuticals. Experience planning and executing competitive intelligence activities for scientific and medical congresses. Experience supporting cross-functional teams across multiple stages of the drug development lifecycle. Experience developing competitive landscapes, asset profiles, company profiles, clinical trial trackers, and recurring intelligence updates. Experience leveraging AI and emerging technologies to improve research, analysis, monitoring, and knowledge management.
Remote opportunity but candidate must be in Southern CA area! Position Summary: The Associate Director, Competitive Intelligence is responsible for generating timely, objective, and actionable competitive intelligence that supports informed decision-making across the organization. Working collaboratively with cross-functional partners, this individual will monitor the evolving external landscape, synthesize complex scientific and business information, and deliver high-quality intelligence products that enhance organizational awareness of the competitive environment. This role is focused on competitive intelligence, strategic analysis, congress intelligence, knowledge management, and external landscape monitoring across Companys portfolio and therapeutic areas of interest. The successful candidate is scientifically curious, analytical, and proactive, with the ability to identify meaningful developments, distinguish signal from noise, and communicate relevant insights clearly and concisely. Responsibilities : Monitor the external environment for scientific, clinical, regulatory, commercial, financial, partnership, and competitive developments relevant to Companys portfolio and therapeutic areas of interest. Develop and maintain competitive landscape assessments, competitor profiles, asset summaries, clinical trial trackers, timelines, and other intelligence resources. Proactively identify and communicate significant competitive developments, emerging trends, and industry changes to relevant stakeholders. Gather, evaluate, and synthesize information from scientific literature, clinical trial databases, regulatory agencies, congress presentations, company disclosures, investor communications, and other publicly available sources. Prepare concise competitive intelligence reports, presentations, executive summaries, trackers, and recurring updates tailored to a variety of internal audiences. Lead planning, coordination, and execution of competitive intelligence activities for major scientific and medical congresses, including pre-congress planning, intelligence collection, and post-congress analyses. Maintain competitive intelligence repositories, monitoring systems, and knowledge management resources to ensure information is organized, current, and readily accessible. Partner with Commercial, Medical Affairs, Regulatory Affairs, Clinical Development, Research, and other cross-functional teams to understand evolving intelligence needs and provide timely support. Respond to ad hoc competitive intelligence requests by conducting focused research and preparing objective summaries and analyses. Support cross-functional planning discussions by providing objective, evidence-based intelligence on competitor activity, external trends, and therapeutic landscape evolution. Continuously improve competitive intelligence processes, workflows, templates, and reporting practices to increase efficiency, consistency, and impact. Evaluate and incorporate emerging technologies, including AI-enabled tools, to enhance intelligence gathering, synthesis, monitoring, and knowledge management. Manage relationships with external intelligence vendors, consultants, and information providers, as appropriate. Ensure all competitive intelligence activities are conducted in accordance with company policies, legal requirements, and industry ethical standards. Perform other duties as assigned. Education/Experience Requirements: Bachelors degree in Life Sciences or a related discipline; advanced degree such as PhD, PharmD, MD, MS, or MBA preferred. Equivalent combination of education and applicable job experience may be considered. At least 8 years of relevant experience in biotechnology, pharmaceuticals, life sciences consulting, competitive intelligence, scientific strategy, medical strategy, commercial strategy, or related functions. Additional Skills/Experience Requirements: The ideal candidate will embody Companys core values: Courage, Community Spirit, Patient Focus and Teamwork. Strong understanding of drug development, clinical research, regulatory pathways, commercialization, and the biotechnology industry. Demonstrated ability to efficiently gather, evaluate, and synthesize information from diverse scientific, clinical, regulatory, commercial, and business sources into clear, concise, and relevant insights. Experience independently leading competitive intelligence projects, managing multiple workstreams, and delivering high-quality outputs under time-sensitive conditions. Excellent analytical, written, verbal, presentation, and organizational skills. Ability to communicate complex scientific and business information clearly to cross-functional stakeholders. Ability to manage multiple priorities while working independently and collaboratively in a fast-paced environment. Demonstrated scientific curiosity, sound judgment, attention to detail, and a proactive approach to problem-solving. Organized, adaptable, detail-oriented, and able to prioritize information based on business relevance. Ability to travel domestically and internationally up to 10%, including attendance at scientific and medical congresses, professional meetings, and occasional company meetings. All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote. Preferred Skills/Experience: Experience in rare disease, nephrology, rare metabolic diseases, or specialty pharmaceuticals. Experience planning and executing competitive intelligence activities for scientific and medical congresses. Experience supporting cross-functional teams across multiple stages of the drug development lifecycle. Experience developing competitive landscapes, asset profiles, company profiles, clinical trial trackers, and recurring intelligence updates. Experience leveraging AI and emerging technologies to improve research, analysis, monitoring, and knowledge management.
Genmab
Plainsboro, New Jersey
At Genmab, we are dedicated to building extra not ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! At Genmab, we are driven by our purpose: to transform the lives of people with cancer and other serious diseases through innovative antibody medicines. In this role, the Senior Director, Head of Medical Affairs - International Markets, will serve as the strategic and scientific leader across International Markets, guiding medical vision, execution, and excellence to ensure that every decision reflects Genmab's commitment to patients, science, and integrity. Work arrangement: This role offers flexibility to work away from the office for 20%-40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager. Role Overview The Senior Director, Head of Medical Affairs - International Markets, reporting directly to the Senior Vice President, Global Head of Medical Affairs, will lead the global medical strategy and execution for Genmab's portfolio across International Markets outside of the U.S., Japan, EU, and other select markets. This leader will be responsible for establishing and advancing a world-class Medical Affairs organization that enables successful product launches, lifecycle management, scientific leadership, and long-term value creation across International Markets. The Senior Director will serve as the senior medical leader for Medical Affairs International Markets, providing strategic direction across medical affairs, evidence generation, scientific engagement, and medical operations while ensuring alignment with Global Medical Affairs, International Markets Commercialization, Clinical Development, Regulatory, Market Access, and other cross-functional partners. This role will guide the evaluation of medical capabilities required for distributor and partnership markets, establish scalable medical operating models, and ensure Genmab's scientific excellence is consistently represented across diverse healthcare systems and geographies. Success in this role requires an accomplished executive with extensive global Medical Affairs leadership experience in oncology, demonstrated success leading organizations through late-stage development and product launches, and the ability to influence enterprise strategy through scientific leadership. Key Responsibilities Regional Medical Strategy & Leadership or Develop and Lead International Markets Medical Strategy Develop and execute the Medical Affairs strategy for International Markets aligned with compound development strategies and corporate objectives to ensure successful product launches and optimized patient outcomes. Translate Global Medical Affairs strategy into regionally relevant medical priorities while maintaining consistency in scientific messaging and execution. Provide strategic medical leadership supporting both marketed products and pipeline assets across International Markets. Drive long-term medical planning that supports sustainable growth, scientific leadership, and patient access. Medical Leadership Across International Markets Build and lead a high-performing International Markets Medical Affairs organization capable of supporting Genmab's expanding global footprint. Establish scalable medical operating models supporting both affiliate and distributor/partnership markets. Evaluate medical infrastructure requirements for new market entry opportunities. Develop organizational capabilities that enable scientific excellence across diverse healthcare systems. Scientific Leadership and Evidence Generation Lead regional evidence generation strategies including Real World Evidence, investigator-sponsored research, observational studies, and collaborative scientific initiatives. Ensure regional insights inform global development programs and lifecycle management strategies. Oversee scientific communications, publication planning, congress strategy, and medical education activities. Maintain scientific rigor while ensuring compliance with global and local regulatory requirements. External Scientific Engagement Build and sustain strategic relationships with Key Opinion Leaders, scientific societies, academic institutions, patient advocacy organizations, and healthcare decision-makers across International Markets. Represent Genmab at major international scientific congresses and advisory boards. Champion scientific exchange that advances patient care while generating meaningful external insights. Ensure customer insights are systematically captured and incorporated into medical and development strategies. Cross-Functional Leadership Serve as the senior Medical Affairs representative on the International Markets Leadership Team. Partner closely with International Markets Commercialization, Global Medical Affairs, Clinical Development, Regulatory Affairs, Market Access, Commercial, Pharmacovigilance, Medical Operations, Compliance, Legal, Technical Operations, and other enabling functions. Ensure cross-functional alignment supporting successful launches, lifecycle management, and business objectives. Strengthening collaboration between Global Medical Affairs and International Markets to ensure a unified scientific voice. Partnership and Distributor Medical Strategy Lead medical evaluation and due diligence activities supporting partnership and distributor opportunities. Define medical governance frameworks supporting external collaborations. Ensure scientific consistency across partner organizations while maintaining Genmab standards. Support business development activities through medical expertise and strategic evaluation. Governance, Compliance and Quality Establish governance frameworks defining medical decision rights, oversight structures, performance management systems, and scientific standards across International Markets. Ensure all Medical Affairs activities comply with local regulations, industry codes, and Genmab policies. Maintain inspection readiness and promote continuous improvement across medical processes. Foster a culture of integrity, quality, transparency, and ethical scientific leadership. People Leadership Recruit, develop, and retain exceptional Medical Affairs talent across International Markets. Build a diverse, inclusive, and high-performing leadership team. Develop future leaders through succession planning, coaching, and capability development. Inspire collaboration across a highly matrixed global organization while fostering accountability and innovation. Requirements MD, PharmD, PhD, or equivalent advanced scientific degree required. Minimum 15 years of progressive leadership experience within the pharmaceutical or biotechnology industry. Minimum 10 years leading regional or global Medical Affairs organizations. Significant oncology and/or hematology experience preferred. Demonstrated success leading Medical Affairs during late-stage development, pre-launch, launch, and lifecycle management. Experience working in International Markets including affiliate and distributor business models. Proven executive leadership experience within highly matrixed global organizations. Demonstrated experience translating scientific strategy into operational execution. Strong financial acumen with experience managing complex organizational budgets and resource allocation. Proven success attracting, developing, and retaining high-performing teams. Leadership Competencies Executive presence with exceptional strategic thinking and organizational leadership. Deep scientific credibility combined with strong commercial and business acumen. Excellent communication and stakeholder management skills with the ability to influence executive leadership. Ability to thrive in complex, rapidly evolving global environments. Demonstrated success leading through ambiguity while driving organizational transformation. Strong cross-cultural leadership capabilities with experience working across multiple regions. Passion for innovation, scientific excellence, and improving outcomes for patients worldwide. Success Measures Successful execution of International Markets Medical Affairs strategy. Excellence in launch readiness and lifecycle medical support. Strength of scientific engagement across International Markets . click apply for full job details
At Genmab, we are dedicated to building extra not ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! At Genmab, we are driven by our purpose: to transform the lives of people with cancer and other serious diseases through innovative antibody medicines. In this role, the Senior Director, Head of Medical Affairs - International Markets, will serve as the strategic and scientific leader across International Markets, guiding medical vision, execution, and excellence to ensure that every decision reflects Genmab's commitment to patients, science, and integrity. Work arrangement: This role offers flexibility to work away from the office for 20%-40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager. Role Overview The Senior Director, Head of Medical Affairs - International Markets, reporting directly to the Senior Vice President, Global Head of Medical Affairs, will lead the global medical strategy and execution for Genmab's portfolio across International Markets outside of the U.S., Japan, EU, and other select markets. This leader will be responsible for establishing and advancing a world-class Medical Affairs organization that enables successful product launches, lifecycle management, scientific leadership, and long-term value creation across International Markets. The Senior Director will serve as the senior medical leader for Medical Affairs International Markets, providing strategic direction across medical affairs, evidence generation, scientific engagement, and medical operations while ensuring alignment with Global Medical Affairs, International Markets Commercialization, Clinical Development, Regulatory, Market Access, and other cross-functional partners. This role will guide the evaluation of medical capabilities required for distributor and partnership markets, establish scalable medical operating models, and ensure Genmab's scientific excellence is consistently represented across diverse healthcare systems and geographies. Success in this role requires an accomplished executive with extensive global Medical Affairs leadership experience in oncology, demonstrated success leading organizations through late-stage development and product launches, and the ability to influence enterprise strategy through scientific leadership. Key Responsibilities Regional Medical Strategy & Leadership or Develop and Lead International Markets Medical Strategy Develop and execute the Medical Affairs strategy for International Markets aligned with compound development strategies and corporate objectives to ensure successful product launches and optimized patient outcomes. Translate Global Medical Affairs strategy into regionally relevant medical priorities while maintaining consistency in scientific messaging and execution. Provide strategic medical leadership supporting both marketed products and pipeline assets across International Markets. Drive long-term medical planning that supports sustainable growth, scientific leadership, and patient access. Medical Leadership Across International Markets Build and lead a high-performing International Markets Medical Affairs organization capable of supporting Genmab's expanding global footprint. Establish scalable medical operating models supporting both affiliate and distributor/partnership markets. Evaluate medical infrastructure requirements for new market entry opportunities. Develop organizational capabilities that enable scientific excellence across diverse healthcare systems. Scientific Leadership and Evidence Generation Lead regional evidence generation strategies including Real World Evidence, investigator-sponsored research, observational studies, and collaborative scientific initiatives. Ensure regional insights inform global development programs and lifecycle management strategies. Oversee scientific communications, publication planning, congress strategy, and medical education activities. Maintain scientific rigor while ensuring compliance with global and local regulatory requirements. External Scientific Engagement Build and sustain strategic relationships with Key Opinion Leaders, scientific societies, academic institutions, patient advocacy organizations, and healthcare decision-makers across International Markets. Represent Genmab at major international scientific congresses and advisory boards. Champion scientific exchange that advances patient care while generating meaningful external insights. Ensure customer insights are systematically captured and incorporated into medical and development strategies. Cross-Functional Leadership Serve as the senior Medical Affairs representative on the International Markets Leadership Team. Partner closely with International Markets Commercialization, Global Medical Affairs, Clinical Development, Regulatory Affairs, Market Access, Commercial, Pharmacovigilance, Medical Operations, Compliance, Legal, Technical Operations, and other enabling functions. Ensure cross-functional alignment supporting successful launches, lifecycle management, and business objectives. Strengthening collaboration between Global Medical Affairs and International Markets to ensure a unified scientific voice. Partnership and Distributor Medical Strategy Lead medical evaluation and due diligence activities supporting partnership and distributor opportunities. Define medical governance frameworks supporting external collaborations. Ensure scientific consistency across partner organizations while maintaining Genmab standards. Support business development activities through medical expertise and strategic evaluation. Governance, Compliance and Quality Establish governance frameworks defining medical decision rights, oversight structures, performance management systems, and scientific standards across International Markets. Ensure all Medical Affairs activities comply with local regulations, industry codes, and Genmab policies. Maintain inspection readiness and promote continuous improvement across medical processes. Foster a culture of integrity, quality, transparency, and ethical scientific leadership. People Leadership Recruit, develop, and retain exceptional Medical Affairs talent across International Markets. Build a diverse, inclusive, and high-performing leadership team. Develop future leaders through succession planning, coaching, and capability development. Inspire collaboration across a highly matrixed global organization while fostering accountability and innovation. Requirements MD, PharmD, PhD, or equivalent advanced scientific degree required. Minimum 15 years of progressive leadership experience within the pharmaceutical or biotechnology industry. Minimum 10 years leading regional or global Medical Affairs organizations. Significant oncology and/or hematology experience preferred. Demonstrated success leading Medical Affairs during late-stage development, pre-launch, launch, and lifecycle management. Experience working in International Markets including affiliate and distributor business models. Proven executive leadership experience within highly matrixed global organizations. Demonstrated experience translating scientific strategy into operational execution. Strong financial acumen with experience managing complex organizational budgets and resource allocation. Proven success attracting, developing, and retaining high-performing teams. Leadership Competencies Executive presence with exceptional strategic thinking and organizational leadership. Deep scientific credibility combined with strong commercial and business acumen. Excellent communication and stakeholder management skills with the ability to influence executive leadership. Ability to thrive in complex, rapidly evolving global environments. Demonstrated success leading through ambiguity while driving organizational transformation. Strong cross-cultural leadership capabilities with experience working across multiple regions. Passion for innovation, scientific excellence, and improving outcomes for patients worldwide. Success Measures Successful execution of International Markets Medical Affairs strategy. Excellence in launch readiness and lifecycle medical support. Strength of scientific engagement across International Markets . click apply for full job details