11 jobs found

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. Summary Description The Executive Director, International Value & Access, will report to the SVP, Head of Pricing, Access, Value and Evidence (PAVE) and will be a member of PAVE leadership team. The position and his/her team will be responsible for the strategic planning, design and local implementation of access and pricing strategies to support the launch, pricing and reimbursement of BioMarin's products in markets outside of the US in Europe, MEA, LaTam and APAC. This position has a flexible location in Europe, LatAm or East US Responsibilities Execute strategies and plans addressing health care payer-related barriers to product access Monitor the regional reimbursement environment by tracking government policy initiatives and associated commercial implications, and profiling reimbursement environment for marketed and pipeline products Utilize key market research, advisory board, and other patient/field inputs to continually monitor market trends and dynamics and assess their business implications Monitor relevant country-specific policy initiatives and associated commercial implications, and profile the environment for marketed and pipeline products Collaborate with Country Managers and Area Directors to analyze the commercial implications of new or pending reimbursement policy and/or legislative proposals potentially impacting reimbursement for BioMarin products Participate on brand, government contracts/pricing, and other commercial teams Collaborate closely with Global PAVE teams (HEOR, Pricing, V&A) and other commercial groups including Field Sales, Market Planning, Marketing, and Commercial Operations across the region Collaborate closely with other corporate groups also monitoring the legislative and regulatory environment (e.g. Government Affairs, Regulatory Affairs, and Medical Affairs) Assist Country Managers and Areas Directors in the preparation and submission of reimbursement dossiers Monitor development of government programs for reimbursement of orphan drugs/rare diseases Scope International scope including Europe, LatAm, MEA and APAC Education BS/BA degree in Business or Life Sciences Fluent English. Experience Minimum 15+ years of commercial experience in the pharmaceutical industry, with minimum of 10+ years management experience in Market Access Experience leading multicultural teams Experience with specialty care products in highly competitive markets; experience in rare diseases market would be a plus Proven track record of marketing across multiple stages of a product's life cycle Successful Global launch experience in specialty and/or rare disease, preferably in the specific therapeutic area Strong leadership skills and business acumen Deep strategic marketing expertise (launch, branding, analytical skills, targeting, segmentation, life cycle management in particular) Demonstrated agility, accountability, sense of urgency and team spirit Capability to embark and enroll cross functional stakeholders at all levels of the organization Ability to build strong relationships across cultures, backgrounds and functions Can manage complex situations and has demonstrated ability to make decisions Strong planning and project management skills - can and has successfully driven projects involving several departments and functions Ability to convey complex information succinctly & simply (including verbal, written and in presentations) Resilience and openness to change Complies with Company guidelines and country/industry standards on ethics and compliance and acts as a role model for ethical behavior Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. Summary Description The Executive Director, International Value & Access, will report to the SVP, Head of Pricing, Access, Value and Evidence (PAVE) and will be a member of PAVE leadership team. The position and his/her team will be responsible for the strategic planning, design and local implementation of access and pricing strategies to support the launch, pricing and reimbursement of BioMarin's products in markets outside of the US in Europe, MEA, LaTam and APAC. This position has a flexible location in Europe, LatAm or East US Responsibilities Execute strategies and plans addressing health care payer-related barriers to product access Monitor the regional reimbursement environment by tracking government policy initiatives and associated commercial implications, and profiling reimbursement environment for marketed and pipeline products Utilize key market research, advisory board, and other patient/field inputs to continually monitor market trends and dynamics and assess their business implications Monitor relevant country-specific policy initiatives and associated commercial implications, and profile the environment for marketed and pipeline products Collaborate with Country Managers and Area Directors to analyze the commercial implications of new or pending reimbursement policy and/or legislative proposals potentially impacting reimbursement for BioMarin products Participate on brand, government contracts/pricing, and other commercial teams Collaborate closely with Global PAVE teams (HEOR, Pricing, V&A) and other commercial groups including Field Sales, Market Planning, Marketing, and Commercial Operations across the region Collaborate closely with other corporate groups also monitoring the legislative and regulatory environment (e.g. Government Affairs, Regulatory Affairs, and Medical Affairs) Assist Country Managers and Areas Directors in the preparation and submission of reimbursement dossiers Monitor development of government programs for reimbursement of orphan drugs/rare diseases Scope International scope including Europe, LatAm, MEA and APAC Education BS/BA degree in Business or Life Sciences Fluent English. Experience Minimum 15+ years of commercial experience in the pharmaceutical industry, with minimum of 10+ years management experience in Market Access Experience leading multicultural teams Experience with specialty care products in highly competitive markets; experience in rare diseases market would be a plus Proven track record of marketing across multiple stages of a product's life cycle Successful Global launch experience in specialty and/or rare disease, preferably in the specific therapeutic area Strong leadership skills and business acumen Deep strategic marketing expertise (launch, branding, analytical skills, targeting, segmentation, life cycle management in particular) Demonstrated agility, accountability, sense of urgency and team spirit Capability to embark and enroll cross functional stakeholders at all levels of the organization Ability to build strong relationships across cultures, backgrounds and functions Can manage complex situations and has demonstrated ability to make decisions Strong planning and project management skills - can and has successfully driven projects involving several departments and functions Ability to convey complex information succinctly & simply (including verbal, written and in presentations) Resilience and openness to change Complies with Company guidelines and country/industry standards on ethics and compliance and acts as a role model for ethical behavior Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Consultant Psychiatrist & Medical Director - North East PICU & Acute We are seeking an experienced full-time Consultant Psychiatrist who will work at Cygnet Hospital Hexham and provide senior medical cover on Franklin ward, our 10 bedded female PICU service. Apart from being the Responsible Clinician at Franklin ward, you will also be the Medical Director for our PICU and Acute services based in the North East of England. Main duties of the job Cygnet Hospital Hexham is a 27 bed mental health facility for women with complex mental health needs, built to meet the latest national specifications for improving mental health within a therapeutic environment. Situated amongst the soft fields and meadows of the Tyne valley, the hospital will provide an important and much needed service for service users within the North East of England. About us Cygnet has been providing a national network of high quality specialist mental health services for more than 30 years and has a reputation for delivering pioneering services and outstanding outcomes. We maintain good relationships with our quality regulators and undergo regular inspections, with 85% of our services rated Good or Outstanding. Job responsibilities Helping others improve and turn their lives around is what we do for thousands of people at more than 150 sites across the UK. This role is a full time position with 0.2 WTE as Medical Director and 0.8 WTE as Consultant Psychiatrist. As a Medical Director you will: Ensure optimal clinical outcomes for the people in our care. Lead on all aspects of clinical practice & serve as an example of operational excellence. Provide leadership for medical staff on both professional and managerial issues whilst monitoring their performance. Supervise all consultants and ensure consultants are supervising SDs and ASs. Provide expert knowledge & support within the service & to the wider team. Ensure quality & compliance with internal & external standards & regulations. Work with colleagues to provide integrated, whole person treatment & care. Ensure regular communication and meetings with medical staff. Assist in recruitment and retention of medical staff to provide a high quality clinical service. Ensure that medical staff are involved in hospital clinical governance. Work in conjunction with hospital managers to lead on the successful implementation of CQC outcomes for 4, 7 and 9. Chair medical advisory committee meetings and attend Cygnet Medical Directors meetings. Liaise with Responsible Officer and Regional Medical Director in respect of concerns about fitness to practice issues for medical staff. As a Consultant Psychiatrist you will: Lead on the provision of high quality care to service users admitted to Franklin Ward. Act as a positive role model, maintaining and demonstrating a positive attitude towards patients, their families, and other staff. Take overall responsibility for patient treatment plans in conjunction with the multi disciplinary team. Assess referrals & undertake mental state examinations of service users. Undertake appropriate investigations, diagnosis & treatment. Conduct ward rounds, patient reviews & clinical audits. Lead the implementation of risk assessment, risk management & embed clinical governance within the service. Supervise reports for Mental Health Act tribunals & management hearings & attend hearings. Liaise with the Ministry of Justice for transfer of patients and approval of leave as required. Maintain good patient records. Ensure regular communication with the Site Medical Director and Hospital Manager. Communicate effectively through regular contact with patients, relatives, staff, directors, and any other concerned bodies; maintaining appropriate reports. Attend and contribute to academic meetings and adhere to the professional standards for CPD as set out by the GMC, the Department of Health and the Royal College of Psychiatrists. Contribute to insert frequency telephone on call rota. Benefits Salary up to £175,000 per year. Generous annual leave entitlement that increases with length of service. 5 days study leave, study budget and in house CPD/peer group programme. Company paid Life Assurance scheme covering 3 salary. Contributory pension scheme. Research opportunities including publishing in The Cygnet Journal and joining the Cygnet Research & Development Group. Teaching opportunities within the Cygnet CESR and MRCPsych programmes. Opportunity to lead and participate in QI & Audit initiatives. Company funded cash plan allowing up to £1,000 per annum in benefits (physiotherapy, osteopathy, optical, dental, consultations, scans, free prescriptions). Gym discounts across the UK, free online fitness classes with ClassPass, nutritional programmes and fitness consultations. Discount schemes including Reward Gateway, NHS Discount and Blue Lights Card. Free meals, on site parking and EAP support. Smart Health Toolkit, including 24 hour GP service with prescription delivery. Electric car scheme. We are looking for someone who is Fully GMC registered & MBBS (or equivalent) qualified. Registered on the specialist register (CCT/CESR), Section 12 and AC Status. Experienced & knowledgeable in insert speciality . Knowledgeable of the Mental Health Act and Code of Practice, along with the Mental Capacity Act 2005 and Code of Capacity. A first rate communicator who can interview, assess & treat patients & write clear, comprehensive medical notes. Committed to continued professional development. Able to work as part of a multi disciplinary team. A member of the Royal College of Psychiatrists (MRCPsych) or equivalent. Requirements The successful candidate will be required to undergo an enhanced DBS and reference check and an offer of employment will be subject to successful clearance. Person Specification Please refer to the job description above. Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975. A Disclosure and Barring Service check will be required to verify any previous criminal convictions. £175,000 a year (depending on experience).

Deputy Medical Director Integrated Urgent Care (IUC) The Deputy Medical Director is integral to the Clinical Leadership and Governance team and reports directly to the Medical Director. This role is responsible for ensuring quality, safety, performance, and innovation across Integrated Urgent Care services and combines corporate leadership with hands on clinical practice. Main duties of the job The Deputy Medical Director is a senior member of the extended multidisciplinary leadership team, driving delivery of organisational priorities and providing clinical leadership across LCW Integrated Urgent Care (IUC) services. The postholderis responsible forthe clinical delivery of IUC services, line managing Senior Clinical Navigators and GPs, and providing leadership to the substantive and sessional GP workforce. They will work closely with the IUC Service Manager and Head of Quality, Patient Safety and Experience to ensure contractual, quality, and regulatory standards are met, including oversight of audits, GP performance, and CQRG reporting. The Deputy Medical Director will need to be a GP. The role requires regular clinical practice across unscheduled care services tomaintainoperational credibility, as well as participation in the clinical on call rota and deputising for the Medical Director asrequired. The postholder will support system partnership working, service transformation and innovation, contribute to bid development, and act as Deputy Clinical Safety Officer whererequired About us London Central & West Unscheduled Care Collaborative (LCW) is a social enterprise delivering high quality urgent and primary care services across London. Now in its 29th year, LCW supports over 4.2 million patients andoperates24 hours a day, 365 days a year. LCW is rated Good by the Care Quality Commission across all domains, reflecting our commitment to safe, effective, responsive,caringand well led services. Our portfolio includes GP practices, Urgent Treatment Centres, out of hours, and integrated urgent care services delivered in partnership with Trusts and providers in London. We are clinically led, values driven and committed to innovation, workforce development and strengthening neighbourhood based care to meet the needs of London's diverse communities. Job responsibilities Hours and Pay £115,000 to £120,000 per annum, prorata 8 management sessions per week with the expectation of working 1 clinicalsessionper week in addition. Key Relationships: Key relationships include executive directors, clinical and governance teams, LCW Heads of post holders, employed and self employed clinical staff, partner organisation Medical/Deputy Medical Directors, ICB Medical/Deputy Directors, Health Education England, GP training hubs, and GP partners in joint ventures. Core Responsibilities: Corporate Clinical Leadership & Governance Work as part of an extended leadership team at LCW, including supporting organisation and team meetings. Provide leadership to the LCW Clinical Leadership and Governance team. Deputise for the Medical Director as and when required and to cover periods of leave. Take part in the clinical on call rota and stay up to date with EPRR systems and processes within LCW. Work clinically in LCW services to cover all services, primarily within IUC, including a mix of triage and face to face sessions. Input into stakeholder meetings, to include but not necessarily limited to: Urgent Community Response Teams PCN/Federation/Alliance meetings Local Authorities ICBs Local Trusts Deal with ad hoc clinical queries from clinicians. Availability to undertake key responsibilities outside of usual working hours in critical circumstances. Chair LCW Medicines Management meetings. Line manage the LCW Medicines Management Lead. Ensure that LCW are meeting the requirements for its controlled drug licence. Work with prescribers across the organisation to support LCW's use of ICB formularies. Ensure medicines management policies and procedures aremaintained. Safeguarding Provide senior clinical oversight of safeguarding across IUC services. Ensure safeguarding policies and SOPs are implemented consistently in operational settings. Act as a senior clinical advisor on complex safeguarding cases. IUC Clinical Delivery: Line manage any substantively employed Senior Clinical Navigators and GPs in our IUC services Clinical leadership for the substantive and self employed GP workforce for LCW IUC services. Work with the IUC service manager and Head of Quality, Patient Safety and Experience to ensure services meet specified and contractual requirements. Lead the production of reports for CQRG meetings for IUC services. Attend partner, ICB and regional meetings. Oversight and understanding of IUC processes and pathways, including basic knowledge of NHS Pathways. Ensurethat IUC services work in partnership with providers and commissioners across ICBs so that LCWremainsaligned with initiatives such asEnd of Lifecare and Urgent Care Plans. GP Performance and Audit: Ensure the LCW clinical audit function is high performing and provides feedback when needed, both when it is positive and when improvement isrequired. EnsureGP registrars have theappropriate complianceto work at LCW, are inducted into the service appropriately, and that any concerns raised by GP supervisors are managed. Respond to any queriesregardingGP performance or behaviour raised by patients or staff. Transformation and Innovation: Contribute to bid writing for the service, including new business and procurements, to support the organisation's strategic direction. Lead on innovation and support the transformation of our services that result in an improved patient experience. This would include taking the lead on innovation that isdeemedpart of LCW's vision and values, as well as collaborating with external stakeholders. Act as the Deputy Clinical Safety Officer role for LCW, deputising for the Clinical Safety Officer asrequired. Complaints, Incidents and Risk: Role model the behaviours and approach set out within the PSIRF policy for LCW. Lead on LCW clinical complaints for IUC services. Work with the Head of Quality, Patient Safety and Experience to ensure clinical incidents are assigned, being investigated and that the learning is being acted upon. Provide leadership to serious incidents, including: Chair 72 hour review meetings and deciding if a commissioning investigation is required. Investigateserious incident investigations using the PSIIRF framework Deliver the responsible officer role for SI investigations. Offer anappropriate level of pastoral support should a GP be involved in a complaint or incident where appropriate and not conflicted. Support and champion patient engagement. Recruitment, Onboarding and Training: Support with the recruitment of GPs to the services, ensuring there are clinical inductions and overseeing their continuous training and compliance. Work in conjunction with the recruitment team and HR to ensure that new clinical recruits have the necessary skills and resources to do their jobs. Working with HR to ensure that the clinical workforce is compliant with training and accreditation requirements and takes appropriate action when necessary. Lead the delivery of education/ updates to the substantive and self employed GP workforce across 6 sessions a year. Support the medical induction and mentoring of new GPs and clinicians working within the service. Attend meetings and provide strategic input, including CQRG, Quality Assurance, Risk Register, Medicines Management, Safeguarding, Complaints, Medical Leadership, external stakeholders, and Regional/National Clinical Governance meetings. Deputise for the Medical Director when needed. Main Conditions of Service Confidentiality All staff employed by LCWUCC have a duty to keep information about staff and patients confidential and not to discuss information unnecessarily or to unauthorised persons. Failure to maintain confidentiality will lead to disciplinary action. Our Values The organisation aims to ensure that no job applicant or employee receives less favourable treatment on the grounds of sex, race, colour, religion, marital status, sexuality, age or disability, or is not placed at a disadvantage by conditions or requirements which cannot be shown to be justifiable. To this end, LCWUCC has an Equal Opportunities Policy, and each employee is expected to contribute to its success. Health and Safety Employees must be aware of the responsibilities placed on them under the Health and Safety at Work Act (1974), and ensure that agreed safety procedures are carried out to maintain a safe environment for employees, patients and visitors. All LCWUCC employees are accountable, through the terms and conditions of their employment, professional regulations, clinical governance, and statutory health and safety regulations, and are responsible for reporting incidents, being aware of the risk management strategy and emergency procedures, and attending training as required. All staff have a responsibility to manage risk within their sphere of responsibility. It is a statutory duty to take reasonable care of their own safety and the safety of others who may be affected by acts or omissions. All managers throughout theorganisation have a responsibility to ensure that policies and procedures are followed, that staff receive appropriate training . click apply for full job details

Cookie Notice Title: Head of Regulatory Submission Project Management Company: Ipsen Biopharm Ltd About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society!For more information, visit us at and follow our latest news on and . Job Description: Job Title: Head of Regulatory Submission Project management Division / Function: Global Regulatory Affairs - Regulatory Operations Manager's Job Title: VP/Head of RegOps Ipsen Job Profile: Regulatory Affairs - regulatory Excellence operations Location: Paris / Ballard or London / Paddington WHAT - Summary & Purpose of the Position The head of Regulatory Submission Project Management provides strategic and operational leadership for a unified Regulatory Project Management (Reg PM) organization overseeing both early-phase (IND and CTR) and late-phase (NDA/MAA/BLA) regulatory submissions globally.This role is accountable for establishing and leading a single, high-performing Regulatory Project Management group that ensures consistent, high-quality, and on-time delivery of regulatory submissions across the full product lifecycle. He/she partners closely with Global Regulatory Affairs, Clinical Development, Biometry, Portfolio Project Management, Pharmaceutical Development and other cross-functional stakeholders to drive submission excellence, risk mitigation, and continuous process improvement.The position directly oversees priority/high exposure submissions and acts as a senior advisor to GRA leadership on feasibility, resourcing and delivery assurance.He/she is responsible for people leadership, capability building, governance, and standardization of regulatory project management practices, acting as the enterprise excellence champion for submission planning and execution. WHAT - Main Responsibilities & Technical Competencies Strategic Leadership & Governance Establish, own and lead a single Regulatory Project Management function covering early development (INDs, CTRs, amendments, maintenance) and late-stage submissions (NDA, MAA, BLA, major variations and extensions). Define and implement a global regulatory submission project management strategy, aligned with Global Regulatory Affairs and RegOps objectives. Develop governance models, escalation pathways, and decision-making frameworks to support complex, cross-regional submissions. Single point accountable as a senior regulatory project management advisor to Global Regulatory Leadership for end-to-end submission delivery assurance across early/late submissions and major lifecycle fillings, ensuring "right first time" quality and on-time execution.Submission Oversight (Early & Late Phase) Provide oversight and/or direct leadership for high-priority, complex, or high-risk submissions, including INDs, NDAs, MAAs, BLAs, and major lifecycle filings. Ensure robust submission planning, scenario planning, and risk/opportunity management across all development stages. Provide direct leadership for priority/high-exposure submissions, ensuring integrated plans (critical path, dependencies, RACI), risk/issue logs, and decision tracking Ensure submission content plans are developed in partnership with GRLs and functional leads and are executed according to agreed quality and timing standards.Operational Excellence & Delivery Ensure consistent execution of submission activities, including: Original applications and major variations INDs, CTRs and amendments Oversee coordination of document authoring, review cycles, publishing readiness, and final submission delivery in collaboration with Publishing Leads. Own the governance for submission-related Health Authority interactions, ensuring robust preparation and rapid, high-quality responses to HA questions (planned Q&A process before questions arrive) Monitor submission metrics, timelines, and quality indicators; proactively identify and resolve risks that could impact submission success. Drive Submission Excellence / continuous improvement through standards, playbooks, metrics and lessons learned, improve cycle time and predictability across the portfolioPeople & Team Leadership Build, lead and develop a Regulatory Project Management organization, including hiring, onboarding, performance management, succession and capability building. Coach and mentor Regulatory Project Managers across experience levels, fostering a culture of accountability, collaboration, and continuous improvement. Allocate resources across early- and late-phase submissions to ensure optimal workload balance and prioritization. Act as a role model for project management excellence and collaborative matrix leadership.Process, Tools & Continuous Improvement Act as the global champion for regulatory project management methodologies, tools, and best practices. Standardize and optimize processes for submission planning, tracking, risk management, and reporting. Capture and share lessons learned across submissions to drive organizational learning.Cross-Functional & External Collaboration Foster strong matrix collaboration across Regulatory Affairs, Clinical Development, PharmDev, Safety, Quality, and external partners. Influence without authority to align stakeholders around submission priorities, trade-offs, and decisions. Represent the Regulatory Project Management function in senior governance forums and, as appropriate, in interactions with Health Authorities. HOW - Behavioural Competencies Required 1) Manage Complexity (Thinking Dexterity) Makes sense of complex, sometimes contradictory inputs across regions/functions; develops scenarios and focuses the organisation on what truly matters for submission success (critical path, trade-offs, priorities). 2) Influences (Being Intentional) Builds commitment across a global matrix without formal authority; balances multiple stakeholder needs, creates win-win solutions, and secures timely decisions in governance forums. 3) Communicates Effectively (Being Intentional) Delivers crisp, structured, executive-ready messages; "tells it how it is" respectfully; uses clear storytelling and reporting to drive decisions, alignment, and urgency around milestones. 4) Ensures Accountability (Making a Real Impact) Promotes single-point accountability and clear ownership; follows through on commitments; creates an environment where accountabilities, timelines, and next steps are explicit and actively managed. 5) Excellence in Execution (Making a Real Impact) Plans and prioritizes to meet commitments under pressure; sets clear KPIs and standards, anticipates risks, and consistently delivers outcomes-especially on priority, high-visibility submissions. HOW - Knowledge & Experience Knowledge & Experience (essential): Significant experience in the pharmaceutical or biotechnology industry. Minimum 10-15 years of experience in Regulatory Affairs/Pharmaceutical Project Management, including extensive regulatory submission and project management experience. Strong portfolio/program PM capability (critical path, scenario planning, dependency management, risk-based decision support).

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! The role The Head of Medical Affairs, United Kingdom (UK) will lead the expansion and execution of Medical Affairs activities across the UK, as Genmab establishes a fully operational affiliate. Reporting directly to the European Medical Affairs organization, the incumbent will serve as the senior medical affairs leader in the UK, responsible for shaping the national medical strategy to deliver the company's first launch together with further expansion of a strong existing research footprint, whilst ensuring continued alignment with regional and global priorities. This role offers a unique blend of strategic leadership and hands on execution in a biotech environment characterized by agility, innovation, and scientific depth. The role will be pivotal in ensuring that medical excellence underpins all affiliate activities, while also representing the United Kingdom within Genmab's broader European and Global organizations. Affiliate Partnership & Cross functional Collaboration Act as a strategic medical partner to the UK General Manager and cross functional leadership team, ensuring full compliance with MHRA regulations, NHS governance standards, and local pharmacovigilance requirements. Ensure scientific and ethical rigor in all affiliate activities, collaborating effectively with Marketing, Market Access, Commercialization, Legal, QA, Regulatory, and other Research & Development and Enabling functions. Establish and track clear medical performance metrics (KPIs) and ensure readiness for quarterly business reviews to drive accountability and continuous improvement. Medical Strategy and Leadership Develop and oversee the UK's Medical Affairs strategy in alignment with European and global medical affairs strategic plans. Act as the primary medical voice, ensuring that local insights inform national strategic priorities. Serve as a member of the European Medical Affairs Leadership Team and UK Leadership Team contributing to the strategic direction & long term vision of the department. Collaborate closely with European Medical Affairs leadership and global strategy teams to provide United Kingdom perspective on opportunities, challenges, and stakeholder needs to ensure a consistent regional & global scientific narrative. Scientific Communication & Evidence Generation Provide the UK medical/scientific perspective with targeted insight compilation, analysis to inform clinical development & commercialization planning. Oversee pan portfolio investigator interactions to enhance medical/scientific exchange & optimize study execution across the UK. Supervise dissemination & discussion of Genmab's scientific/clinical data with investigators and other appropriate HCPs. Develop and execute national conference plans, ensuring active participation in relevant professional society events. Enable externally sponsored UK evidence generation initiatives. External Engagement and Thought Leadership Build and sustain relationships with UK's top Key Opinion Leaders, healthcare and scientific communities, oncology networks, and scientific societies across Genmab's areas of interest. Represent Genmab at key local and regional medical congresses, symposia, and external scientific forums. Partner with patient advocacy and policy organizations to strengthen Genmab's presence as a trusted scientific collaborator. Collect, analyse, and integrate medical and external insights to guide strategy, inform decision making, and demonstrate the measurable impact of Medical Affairs in UK. Launch Leadership Partner cross functionally and drive launch readiness for the company's first and subsequent commercial launches across the UK, ensuring robust scientific engagement, medical education, and field readiness. Oversee launch readiness and lifecycle management across the region with evidence based, patient focused medical input. Lead the development and localization of medical materials, delivery of local advisory boards, and execution of congress strategies. Partner with MA Training to provide high quality scientific training and maintain exceptional standards of scientific/technical expertise. Compliance & Governance Drive the implementation and continuous strengthening of local medical governance frameworks to ensure full compliance and operational excellence. Partner to ensure appropriate review and approval of promotional and non promotional materials to be used across the UK. Collaborate with Pharmacovigilance and Regulatory Affairs to maintain product safety and compliance. People and Team Development Attract, develop, and retain top talent, fostering a culture of collaboration and excellence within the UK's organization, while aligning with Genmab's European values. Provide mentorship and leadership to direct reports, drive superior performance, facilitate professional development, & cultivate future leadership talent ensuring their continuous development. Champion innovation and direct change initiatives to benefit the business and enhance organizational effectiveness. Exemplify Genmab's culture and values, working as One Team. Qualifications & Experience MD, PharmD, or PhD in life sciences or a related discipline. 10+ years of experience in Medical Affairs within the pharmaceutical or biotech industry, with strong exposure to oncology. Strong understanding of UK regulatory and health authority landscape, including MHRA, NICE, NHS England, SMC, and AWMSG, with proven experience engaging across HTA, access, and clinical governance frameworks. Familiarity with EMA processes and broader EU regulatory coordination preferred. Proven record of accomplishment of success in product launches and early affiliate development. Strong understanding of the UK's healthcare landscape, oncology ecosystem, and regulatory environment. Demonstrated ability to collaborate effectively within a matrix organization, balancing regional / global alignment and local execution. Fluent in English (written and spoken). Competencies & Attributes Demonstrates strategic agility and innovative thinking, with the ability to operate effectively in a dynamic, high growth biotech environment while maintaining scientific and operational rigor. Strategic and analytical thinking with operational execution skills. Strong cross functional leadership. Excellent communication and stakeholder engagement skills. Deep scientific curiosity and a patient focused ethos. About You You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted in science approach to problem solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work life balance. Our offices are crafted as open, community based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard working, innovative and collaborative team has invented next generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T cell engagers, antibody drug conjugates, next generation immune checkpoint modulators and effector function enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock Your Socks Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X. 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