Global Medical Affairs Asset Lead (GMAL) Rare Disease remote type Remote locations United States - Remote time type Full time job requisition id R-245009 Career Category Medical Affairs Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Global Medical Affairs Asset Lead (GMAL) Rare Disease What you will do Let’s do this. Let’s change the world. In this vital role you will be co-leading the development and execution of Global product medical strategy, through the Global Medical/Strategic Plan (Global Brand Plan), including lifecycle management, in collaboration with the Product Team/Therapeutic Area Governance, & Portfolio Governance. You will lead the development of scientific evidence gaps, evidence generation strategy & plan in alignment with GBP and cross functional partners. You will support clinical trial conduct and participate in engagement of external key stakeholders in partnership with other functions. Responsibilities: - Provide medical leadership and strategic direction for Amgen's global portfolio in Rare Disease TA - Collaborate with cross-functional teams to develop and execute global medical strategies and plans for products in this TA - Serve as the subject matter expert in rare disease, keeping up-to-date with the latest research, scientific advancements, and market trends. - Develop and maintain relationships with key opinion leaders, medical societies, and other external stakeholders to advance Amgen's scientific and medical objectives. - Lead and participate in global advisory boards, medical education programs, and other medical activities to support the adoption and appropriate use of Amgen's products. - Ensure compliance with all applicable regulations and guidelines related to medical affairs activities. - Oversee the development and execution of medical communication plans, including publications, presentations, and congress activities. - Provide medical input and support for product development, including clinical trial design and data interpretation. - Collaborate with commercial teams to develop and implement medical strategies for product launches and life-cycle management. - Mentor and develop team members, providing guidance and support for their professional growth and development. - Represent Amgen at medical conferences and other scientific meetings, presenting data and engaging with key stakeholders. - Play a key role in identifying and evaluating potential external collaborations and partnerships in chronic weight management space. - Contribute to the development of global medical affairs processes and procedures to ensure compliance, efficiency, and continuous improvement. - Serve as a key point of contact for medical inquiries from internal and external stakeholders. - Stay abreast of competitive landscape and provide insights and recommendations to inform business decisions. - Drive innovation and continuous improvement in the medical affairs function, staying current with industry best practices and trends. - Collaborate with cross-functional teams to support the development and execution of patient-focused initiatives and programs. - Represent Amgen's commitment to patients and healthcare - Participate in development of data communication strategy (including congress) - Support Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data - Support implementation of Medical governance for respective product, which includes: safety and pharmacovigilance as a key and effective partner with GRAAS, global risk management/minimization in collaboration with GRAAS What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Medical Asset Lead we seek is a medical strategy leader with these qualifications. Basic Qualifications: Doctorate degree and 4 years of medical asset leadership experience OR Master’s degree and 7 years of medical asset leadership experience OR Bachelor’s degree and 9 years of medical asset leadership experience Preferred Qualifications: - MD plus accredited fellowship, board certified or board eligible - Accredited fellowship in Rheumatology or Allergy and Immunology (Board certified or board eligible) or - PharmD or PhD - 6 years of medical affairs or clinical development experience including in rare disease space - Broad and formal leadership experience: Min 2-3 years of people management experience - Excellent written, oral and presentation skills - Demonstrated ability as a medical expert in rheumatological or rare diseases & ability to navigate in a complex matrix environment - Pharmaceutical product development, product lifecycle and commercialization process knowledge with understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Safety, Regulatory, Value & Access, and Medical Affairs - In-depth experience with opinion leader interactions and management - Pharmaceutical product development, product lifecycle and commercialization process knowledge with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs - Proven ability to lead, manage, and motivate others in a complex, multi-functional, multi-national matrix environment - Skilled at effectively presenting ideas and documenting complex medical/clinical concepts in both written and oral communication - Network of customer contacts in therapeutic area a plus - Finance/budgeting and resource management experience What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: - A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts - A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan - Stock-based long-term incentives - Award-winning time-off plans - Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Salary Range 217,673.10USD -294,498.90 USD

Title: Medical Director, Gastroenterology Therapeutic Area, US Medical Affairs Location: Horsham, Pennsylvania, United States of America Job Description: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Medical Affairs Group Job SubFunction: Medical Affairs – MD Job Category: Scientific/Technology All Job Posting Locations: Horsham, Pennsylvania, United States of America Job Description: We are searching for outstanding talent for Medical Director, Gastroenterology, US Medical Affairs to join the Gastroenterology TA team within the US Immunology Medical Affairs organization located in Horsham, PA. About Immunology Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Purpose: This role will be a key member of the Medical Affairs Gastroenterology Therapeutic Area (TA) Team and will report to the Senior Director, Gastroenterology TA Lead within the broader US Medical Affairs- Immunology organization. They will work closely with the other Gastroenterology Medical Directors (and Associate Directors) as well as partners in US and Global Medical Affairs, Real World Value and Evidence (RWV&E), Population Health, Epidemiology, R&D, Biostatistics, and US and Global Commercial Team members supporting Immunology and Gastroenterology within the Johnson & Johnson Innovative Medicine organization to create, shape, influence, and drive strategy for GI pipeline and approved products including evidence generation plans and subsequent execution, ensuring alignment with business objectives and regulatory standards. They will also lead and/or contribute to the development of related abstracts and manuscripts as either an author or reviewer. The Medical Director, Gastroenterology will also be responsible for leading the strategic development and execution of US Medical Affairs-sponsored and supported clinical studies (e.g. Phase IIIb/IV trials, Post-Marketing Requirement studies, and investigator-initiated and collaborative studies) for company products in the Gastroenterology TA. Also, partnering with other GI team members in the US and Global Medical Affairs Organization, as well as Real World Value and Evidence (RWV&E), Epidemiology, R&D, biostatistics, commercial Marketing brand, and field based (e.g. MSL, commercial, and payer-facing value and evidence) teams they will shape the clinical and economic value narrative for one or more GI products/indications by participating in and/or leading their Integrated Evidence Team (IET), accountable for a strong scientific strategy and its execution through evidence generation efforts and their subsequent impactful presentation and dissemination approaches. If you are a strategic thinker with a passion to advance clinical science aspiring to improve the lives of patients with IBD, this is your opportunity to make a difference! You will be responsible for: Develop and execute (as Study Responsible Physician [SRP]) Medical Affairs sponsored clinical study programs, including but not limited to Phase 3b/4 trials, registries, real-world evidence studies, investigator-initiated and/or collaborative studies in the Gastroenterology TA. Contribute to and/or lead study design, protocol development, clinical study report and publication development. Work closely with the matrix clinical trial teams and external investigators/KOLs on study operations and provide program leadership and medical oversight. - Contribute to US GI Medical Affairs strategy, e.g. by leading one or more approved and pipeline GI products/indications Integrated Evidence Teams (IETs), working cross-functionally with partners within the GI Integrated evidence team (IET), including Medical Science Liaison (MSL) team leaders, RWV&E, Field V&E, SCG, Marketing team brand leads, as well as potentially IBD Disease Area Stronghold (DAS), R&D, Global Medical Affairs and Global Commercial partners to promote and execute the GI TA Strategy for establishing access as well as plans for and progress and outcomes for evidence generation activities and Data Dissemination Plans. - Contribute to the preparation of regulatory submissions and interactions with Health Authorities (and particularly the FDA) and helps to ensure regulatory post-marketing commitments are efficiently satisfied with cost-effective, efficient, and scientifically rigorous methods. - Will contribute to, and potentially lead (as the Integrated Evidence Team Lead [IETL]), the cross-functional team to develop and maintain a strategically aligned and annually updated Integrated Evidence Generation Plan (IEGP) for approved and pipeline GI products/indications. Also will support payer-related materials and evidence needs to scientifically support market access efforts. - Reviews and evaluates Investigator-Initiated Study (IIS) concepts, champion prioritized concepts through appropriate review, approval, & funding, and monitor study progress/milestones. - Contributes as a subject matter expert on previous and new data in support of US Immunology approved (or planned) GI drugs and indications, partnering particularly with respective marketing brand teams (as well as other commercial and IET partners, including RWVE, SCG, V&E Field and Med Info and other CAC partners). - Actively partners with individuals in the Gastroenterology TA, and other groups inside and outside Medical Affairs (e.g. Biostats, GCO, Regulatory Affairs, QA and QC), to create analysis plans, perform safety data review for database locks, and ensure compliance with study monitoring and other SOP/GCP requirements (and support related audits, as needed). - Support the fulfillment of medical information requests from field medical and field commercial teams. Support/lead the development of medical education content for field medical team. Partner with medical communications and scientific exchange teams on content development, review, and approval. - Contributes to or leads the development of abstracts and manuscripts related to Innovative Medicine supported and sponsored studies, including cumulative and/or directed safety experience. - Develop strong relationships with IBD key opinion leaders (KOLs), collaborating with new and established leaders in the field of IBD through clinical trial development and various medical affairs activities. Establish and foster relations with medical societies and patient advocacy organizations. Qualifications / Requirements: - An MD/DO degree (or international equivalent) is required. Current or prior Board Certification (or Eligibility) in Gastroenterology and/or experience in R&D (or otherwise designing and conducting clinical trials) is preferred. - A minimum of 8 years of combined industry, academic, clinical research, or other clinical practice experience is required, of which at least 3 years in the pharmaceutical industry, including accountability for successful and timely execution of key deliverables. - Gastroenterology and/or Immunology Therapeutic Area expertise is preferred. - Prior industry/medical affairs experience, including commercial brand support, medical launch support experience, and clinical study, registry, or real-word evidence study support and execution is preferred. - Prior R&D (or other) experience including responsibility and accountability for clinical study planning and execution is a strong asset. - Excellent analytical and strategic thinking aptitude, scientific writing proficiency, and strong organizational, written, and verbal communication skills, including proficiency in effective and impactful scientific oral presentations is essential. - Strong leadership, teaming, and collaboration skills and the ability to work in a matrix environment, collaborating effectively with many cross functional partners and success in participating in and leading cross functional teams to execute on deliverables is essential. - People leadership is an asset. - Up to 20% travel (primarily domestic & limited international) is required. - This position is located in Horsham, PA and follows a hybrid schedule of three days in the office and up to two days remote per week. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. #LI-Hybrid #LI-LGREEN3 Required Skills: Preferred Skills: Clinical Research, Gastroenterology, Immunology, Medical Affairs, Research and Development, Strategic Thinking

Role Description The U.S. Executive Director of Medical Affairs (US EDMA) resides in the Value & Implementation (V&I) organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research. The US EDMA understands our company’s enterprise-level strategies and leads cross-functionally with the V&I Global Medical and Scientific Affairs Therapeutic Area (V&I GMSA TA) teams to translate Global V&I goals into the relevant U.S. country-level goals and priorities. The US EDMA is responsible for the creation and execution of the overall therapeutic-aligned U.S. strategy and Country Medical Affairs Plans (CMAPs). They also lead the Strategic Scientific Engagement Plan for the U.S. and ensure field teams execute on Integrated Field Medical Plans (FMPs) to achieve field medical priorities. Primary Responsibilities: - Leadership and Management - Serves as a senior leader in the USMA organization, sets the strategic direction for the TA program, and oversees the execution of the field medical team of U.S. RMSDs. - Assesses and determines U.S. strategy and tactical plans for TA-aligned deliverables that align with V&I Goals. - Establishes and maintains strategic partnerships with Health Systems (HS) by leading RMSD medical account planning initiatives. - Provides scientific consultation to our company’s Research & Development. - Ensures compliant ways of working from strategy to execution. - Collaborates with external alliance partners for approved ways of working. - Leads a complex team of field team leaders and strategic directors of medical affairs roles. - Develops and effectively manages the yearly budget. - Oversees and ensures appropriate approval of key decisions around program-related expenses. - Strategic Planning and Collaboration - Responsible for the creation and implementation of the CMAPs in collaboration with necessary internal stakeholders. - Engages with Country Medical Affairs and TA leadership for strategic alignment and resource allocation. - Leads strategic insight collection to align with the USMA strategy. - Provides oversight of Field Medical strategies and tactics that align with USMA objectives. - Coordinates and leads research and scientific field medical capabilities. - Coordinates with V&I Global Medical & Scientific Affairs for investigator-initiated studies (IIS). - Coordinates with Outcomes Research through the USMA Payer Access Teams (PATs). - Coordinates strategy, planning, and execution of scientific congress responsibilities. Qualifications - Doctoral degree (MD, PharmD, PhD) with demonstrated ability to effectively lead and coach scientific/medical colleagues. Requirements - Prior industry experience (at least seven years) preferably within relevant TA programs (infectious diseases/vaccines). - Five years of front-line field medical leadership in the pharmaceutical industry. - Demonstrated successful leadership of strategic initiatives. - Proven success operating in a complex, heavily matrixed global organization. - Embraces an AI-first mindset by leveraging artificial intelligence (AI) tools. - Leads with confidence, proactively and independently, with outstanding executive communication skills. - Trusted to deliver high-level communications/presentations to senior leadership. - In-depth expertise in local regulatory frameworks and pharmaceutical compliance requirements. - Proven capability to cultivate and sustain strategic partnerships. - Strong executive leadership with a track record of leading high-performing teams. - Deep therapeutic knowledge and thought leadership in disease areas aligned with TA programs. - Comprehensive understanding of the U.S. health-care ecosystem. - Exceptional organizational and prioritization skills. - The ability to travel up to 50%. Preferred Experience and Skills - Scientific/medical research and publication experience in the TA. - Strong working knowledge of Microsoft Office Suite, Veeva, and other systems used by field medical teams. - Demonstrated learning agility and experience managing field teams in relevant TAs. Benefits - Medical, dental, vision healthcare and other insurance benefits (for employee and family). - Retirement benefits, including 401(k). - Paid holidays, vacation, and compassionate and sick days.

Role Description You will lead Abbott Structural Heart’s Field Clinical organization, including Field Clinical Leads (FCLs) and Specialists, to drive excellence across clinical trials, physician training, and commercial readiness. This role ensures seamless execution from pre-market clinical studies through post-approval commercialization by integrating Clinical Affairs, Commercial, and Training. The leader sets strategy, governance, and standards to enable high-quality trial execution, site launches, and consistent procedural outcomes across regions. Reporting to the DVP, Clinical Affairs, this position supports TAVI and TMTI programs with scope to expand. Remote role with around 70% travel. Qualifications - Bachelor’s degree required (Life Sciences, Nursing, or related field). Cath Lab Tech certification strongly preferred. - 10+ years of experience across cath lab practice, cardiology clinical trials (including pre-market devices), and field clinical engineering, with a proven track record of leading research and operational programs. - 7+ years of people leadership in field-based clinical teams. - Deep expertise in TAVI, TMTI, or comparable structural/interventional cardiology therapies. - Strong background in cath lab/OR environment with procedural knowledge. - Knowledge of GCP and medical device clinical study requirements (ISO 14155). - Proven ability to lead through others, scale organizations, and drive cross-functional execution. - Strong leadership, communication, and stakeholder management skills. - Ability to manage competing priorities and respond to change in a dynamic environment. - Willingness to travel around 70%. Requirements - Lead, develop, and scale a high-performing Field Clinical organization, including FCLs and Specialists. - Define roles, coverage models, and performance standards to ensure optimal regional execution. - Coach and mentor FCLs in trial leadership, case expertise, and stakeholder management. - Drive consistency, accountability, and clinical excellence across regions. - Provide strategic oversight of clinical trial execution, ensuring protocol adherence, data quality, timelines, and budget. - Oversee regional trial performance through FCLs, including site activation, enrollment, and engagement. - Partner with Clinical Affairs and Operations to remove barriers and optimize trial delivery. - Ensure alignment between field execution and global clinical strategy. - Establish standards for procedural support and clinical excellence across investigational and commercial cases. - Ensure appropriate field coverage for complex cases and proctoring through FCLs and Specialists. - Maintain strong connection to the field, with selective hands-on engagement as needed. - Ensure consistent, high-quality physician experience and patient outcomes. - Oversee and standardize physician training, proctoring, and site start-up programs. - Ensure FCLs and field teams effectively train physicians, research staff, and hospital teams. - Partner with Training to design and evolve curriculum leveraging field insights. - Drive scalable models for onboarding, advanced education, and procedural excellence. - Lead clinical readiness for commercial launches, ensuring alignment across Clinical and Commercial teams. - Partner with Commercial leadership to align field clinical strategy with business priorities. - Support KOL engagement and ensure clinical credibility in customer interactions. - Enable strong relationships between field teams and hospital stakeholders. - Optimize field logistics, case coverage models, and resource allocation. - Drive effective collaboration across Clinical Affairs, Commercial, Marketing, and Training. - Establish systems to track performance, outcomes, and field activity. - Ensure compliance with GCP, regulatory requirements, and company policies. Benefits - Career development with an international company where you can grow the career you dream of. - Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan. - An excellent retirement savings plan with high employer contribution. - Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. - A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. - A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.