Post job

Medical Director jobs at Genentech

- 46 jobs
  • Principal Medical (Science) Director - Immunology (Rheumatology-Nephrology)

    Genentech 4.5company rating

    Medical director job at Genentech

    A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. The Opportunity We're seeking a dynamic, patient-focused medical leader to join the US Medical (USM) Immunology team. This critical "player/coach" people leadership role is responsible for the day-to-day oversight, in partnership with the Therapeutic Area Lead, of the Rheumatology and Immune-Mediated Kidney Diseases Medical Network and portfolio. Reporting to the Therapeutic Area Lead, you will manage a group of Medical Directors/Medical Science Directors, providing exceptional clinical, scientific, and people leadership. In USM, we focus on broadening opportunities for patient access by ensuring that health care stakeholders have the evidence they need on our products and the confidence in that evidence to make informed treatment decisions. As a key pillar in the broader Genentech organization, USM has a pivotal role in bridging internal partner functions (including Research, Product Development, Commercial, and Government Affairs) and collaborating across the dynamic healthcare ecosystem to ultimately deliver better patient outcomes while making care more accessible and affordable for all. The Principal Medical Director / Medical Science Director drives and guides medical strategy and tactics aimed at maximizing medical progress, while serving as the guardian for high standards of compliance, ethics, and safety. They will play a critical role to establish and maintain professional relationships with key medical experts in their field and will oversee all aspects of medical product support including collaboration with the relevant stakeholders to drive timely data generation and dissemination. They are expected to maintain an in-depth understanding of the medical strategy and relevant clinical and payer issues, while ensuring Genentech's partners understand key trends and shifts in the external healthcare landscape. They understand and evaluate their team and organization's opportunities and constraints and build capabilities with an enterprise mindset. Key Responsibilities Lead with a dynamic, people-first approach that empowers teams, fosters collaboration, and cultivates an inclusive, high-performance culture Attract and retain top talent to meet current and future needs Co-own with the team, the medical value proposition of product / pipeline & its contextualization in given therapeutic area(s) in order to implement medical strategies and tactics Consistently engage with customers (patients, payers, healthcare professionals, professional societies, & cooperative groups) to understand their evolving medical needs and identify knowledge gaps & opportunities for collaboration, & scientific exchange through various channels to drive medical progress Drive timely development and execution of high quality Phase IIIb/IV clinical trials and investigator-initiated research including study design, protocol writing, approval, implementation and conduct, clinical monitoring, data interpretation and study reports Maintain an in-depth understanding of relevant medical strategy in the context of the healthcare landscape & customers for the US & represent the US perspective in global conversations Collaborate with key stakeholders to prioritize the most important work, meet enterprise resource needs, and ensure fluidity and flexibility of people across activities (initiatives, projects, WPTs, etc.) Create a culture grounded in trust, mutual respect and transparency in decision making that empowers individuals to self-organize and prioritize Serve as a trusted resource for the team, including providing mentorship to direct reports and support in decision making; empower individual contributors closest to the work to make decisions while providing input as requested Identify and address training and development needs, inspire high performance by providing strategic leadership, setting goals, removing roadblocks, providing feedback, and coaching to capabilities, and actively promote an inclusive environment by supporting coaching, mentoring, and development opportunities. Who You Are Qualifications & Experience Advanced Clinical/Science degree (e.g., MD, PhD, PharmD) 7+ years of pharmaceutical / biotechnology industry experience Experience in drug development (Phase I-IV), medical writing, and data analysis, with a thorough understanding of US regulatory/FDA requirements. Demonstrated ability to coach, mentor, and develop leaders, and to build relationships with and identify the needs of patients, providers, and payers. Substantive understanding of corporate legal and compliance, including GCP, OIG, and other guiding elements of the business. Proven track record of collaborating, coaching, and influencing outcomes in complex organizations and projects, embracing an agile mindset and new digital healthcare landscapes to serve patient needs. Great team player; Highly collaborative; Good interpersonal and influencing skills; Can effectively and quickly establish rapport Preferred Qualifications & Experience 5+ years of Medical Affairs experience Rheumatologist, Nephrologist, or extensive track-record in the therapeutic area. A combination of relevant clinical practice plus industry experience highly preferred Previous people management experience Travel Requirements The position is located in South San Francisco. The position may require up to 25% time traveling. The expected salary range for this position based on the primary location of South San Francisco, CA is $241,900 - 571,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Relocation benefits are not available for this job posting. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $241.9k-571.4k yearly Auto-Apply 60d ago
  • Senior Medical Director, Late Stage Development, Rheumatology

    Genentech 4.5company rating

    Medical director job at Genentech

    By applying our expertise in immunology, Roche/Genentech continues to deliver on its commitment to address unmet needs for patients with kidney diseases. Our industry-leading pipeline continues to make advancements to deliver meaningful options for those affected. Genentech's Late Stage, Rheumatology team is expanding with a Senior Medical Director opportunity. As a leader, you will be instrumental in advancing our commitment to patient care. It is a high-impact, visible role at a time of significant opportunity within the Rheumatology Disease area. The Senior Medical Director leads development of the Clinical Development (CD) strategy and plan and is responsible for ensuring effective and efficient execution for the assigned molecule(s)/indication(s). Senior Medical Directors are expected to perform their responsibilities independently, and effectively lead multiple projects. Our late stage, clinical development organization is structured by therapeutic area and is responsible for developing and executing the late development clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. You will lead, delegate and be responsible for the development and implementation of the CD strategy and/or plan for assigned molecule(s)/indication(s); you will represent CD for the assigned molecule(s)/indication(s) to other internal Roche groups; you will be responsible for ensuring cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution You will collaborate with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc. You may participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance; includes reviewing and providing late stage input into Phase I and II protocols You will lead health authority (HA) interactions, including the development of briefing packages by providing clinical science information and input; you will take a lead role with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation; providing clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc. You will be accountable for training new CST members Who You Are: (Required) You have an MD (MBBS) or MD/PhD; with at least 4 years of clinical, scientific and/or development experience. Board Certified Rheumatologist highly preferred; physicians with substantial experience in rheumatology drug-development may be considered. You have 6+ years of pharma/biotech R&D experience and/or is recognized as an expert in your field; you can effectively contribute to pipeline strategy and lead cross-functional teams. You have experience developing global clinical development plans and have worked with various health authorities. You have significant experience working with the principles and techniques of data analysis, interpretation and clinical relevance. You have demonstrated ability to work with pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships You have significant experience designing and conducting clinical trials (i.e. one or more trials) You have demonstrated experience in late stage development; you have the proven ability to use sophisticated analytical thought, identify innovative approaches and act a mentor You have experience publishing results of a clinical trial in a peer-reviewed journal is required Preferred: You have strong drug development experience in SLE and/or other Rheumatologic diseases You have a strong level of knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process. You have leadership experience. You have strong interpersonal skills: Outstanding interpersonal, verbal, and written communication and influencing skills: have built and cultivated important relationships both inside and outside of the organization and externally; have proven abilities to influence internal partners and stakeholders, thought leaders, national advocacy organizations, national standard-setting bodies, and other relevant external parties. This position will be based in San Francisco, CA or Boston, MA. Relocation benefits are not being offered for this position. The expected salary range for this position based on the primary location of South San Francisco, CA is between $253,500 - $471,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits #PDC2025 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $253.5k-471k yearly Auto-Apply 20d ago
  • Medical Director, Breast Oncology

    Pfizer 4.5company rating

    San Diego, CA jobs

    This position is for a Medical Director within the CDK4 program. This individual contributor position will be responsible for supporting clinical trial(s). The successful candidate should ideally have prior experience in clinical trials and supporting development programs. ROLE RESPONSIBILITIES Study-level Clinical Development Leadership Collaborate with Clinical Scientists to provide clinical leadership across 2-3 study teams that is scientifically rigorous and aligns with company objectives. Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring. Lead peer-to-peer interactions with investigator. Serve as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities. Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team. Strategic Guidance, Clinical Insights & Interpretation Collaborate with Clinical Scientist to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders. Maintains a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans. BASIC QUALIFICATIONS Medical degree and 4 years clinical experience Industry experience preferred PREFERRED QUALIFICATIONS Board certified/eligible in oncology or equivalent Breast Oncology experience preferred Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Relocation support available Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week The annual base salary for this position ranges from $226,300.00 to $377,100.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email ...@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Medical
    $226.3k-377.1k yearly 5d ago
  • Principal Medical (Science) Director - Neuroimmunology

    Genentech 4.5company rating

    Medical director job at Genentech

    The Opportunity At USMA, we focus on broadening opportunities for patient access by ensuring that health care stakeholders have the evidence they need on our products and the confidence in that evidence to make informed treatment decisions. As a key pillar in the broader Genentech organization, USMA has a pivotal role in bridging internal partner functions (including Research, Product Development, Commercial, and Government Affairs) and collaborating across the dynamic health ecosystem to ultimately deliver better patient outcomes while making care more accessible and affordable for all. The Principal Medical Director / Medical Science Director is a player/coach to a team of Medical Directors (MD)/ Medical Science Directors (MSD) and will report to the Therapeutic Area Lead. By putting patients and science at the center of all actions, they drive and guide medical strategy and tactics aimed at maximizing medical progress. They will play a critical role to establish and maintain professional relationships with key medical experts in their field and will oversee all aspects of medical product support including collaboration with the relevant stakeholders to drive timely data generation and dissemination. They are expected to maintain an in-depth understanding of the medical strategy and relevant clinical and payer issues, while ensuring Genentech's partners understand key trends and shifts in the external healthcare landscape. They understand and evaluate their team and organization's opportunities and constraints and build capabilities with an enterprise mindset. They serve as the guardian for high standards of compliance, ethics and safety. Key Responsibilities Who you are Co-own with the team, the medical value proposition of product / pipeline & its contextualization in given therapeutic area(s) in order to implement medical strategies and tactics Consistently engage with customers (patients, payers, healthcare professionals, professional societies, & cooperative groups) to understand their evolving medical needs and identify knowledge gaps & opportunities for collaboration, & scientific exchange through various channels to drive medical progress Drive timely formation and execution of high quality Phase IIIb/IV clinical trials and investigator-initiated research including study design, protocol writing, approval, implementation and conduct, clinical monitoring, data interpretation and study reports Maintain an in-depth understanding of relevant medical strategy in the context of the healthcare landscape & customers for the US & represent the US perspective in global conversations Collaborate with key stakeholders to prioritize the most important work, meet enterprise resource needs, and ensure fluidity and flexibility of people across activities (initiatives, projects, WPTs, etc.) Create a culture grounded in trust, mutual respect and transparency in decision making that empowers individuals to self-organize and prioritize, to ensure engagement and retention Serve as a source for advice seeking by individual contributors on decision making; empower individual contributors closest to the work to make decisions while providing input as requested Identify and address training and development needs, inspire high performance by providing strategic leadership, setting goals, removing roadblocks, providing feedback, and coaching to capabilities, and actively promote an inclusive environment by supporting coaching, mentoring, and development opportunities. Required Qualifications & Experience Advanced degree (MD, PhD, PharmD) Post-graduate degree required (e.g. MD, PhD, PharmD) 5+ years of pharmaceutical / biotechnology industry experience Experience in drug development (Phase I-IV), medical writing, and data analysis, with a thorough understanding of US regulatory/FDA requirements. Demonstrated ability to coach, mentor, and develop leaders, and to build relationships with and identify the needs of patients, providers, and payers. Substantive understanding of corporate legal and compliance, including GCP, OIG, and other guiding elements of the business. Proven track record of collaborating, coaching, and influencing outcomes in complex organizations and projects, embracing an agile mindset and new digital healthcare landscapes to serve patient needs. Preferred Qualifications & Experience 5+ years of Medical Affairs or Product Development or is a recognized expert in the field Strong academic/teaching background Previous people management experience Travel Requirements The position is located in South San Francisco. The position may require up to 25% time traveling. The expected salary range for this position based on the primary location of South San Francisco, CA is $241,900 - 571,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Relocation benefits are not available for this job posting. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $241.9k-571.4k yearly Auto-Apply 60d+ ago
  • Lead Medical Director, Late Stage Development, Rheumatology

    Genentech 4.5company rating

    Medical director job at Genentech

    Genentech is excited to be expanding its Late Stage Rheumatology team. Our Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II - III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The Lead Medical Director makes major contributions to development of the Clinical Development (CD) strategy and plan and is responsible for effective and efficient execution for the assigned molecule(s)/indication(s). You will support the development and implementation of the Clinical Development Plan (CDP) for assigned molecule(s)/indication(s); gathering and analyzing data and information necessary to create the CD plan. You will collaborate with a variety of internal/external partners & stakeholders, as well as multidisciplinary internal groups, including business development, research, commercial, legal, etc. You may participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input & guidance; including reviewing and providing late stage input to Phase I & II protocols. You have a demonstrated understanding of Phase II - III drug development. You will take an active role with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Provides clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc. You will be responsible to ensure strategic and operational alignment of the CD plan with the relevant CD strategy, strategic and annual LCP; you will work with other CST members and relevant sub-teams to develop CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.) You may consult to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s) Who You Are: (Required) You have an MD/MBBS, MD/PhD, 2+ years clinical experience; Board Certified Rheumatologist highly preferred. You have significant experience working with the principles and techniques of data analysis, interpretation and clinical relevance. You have 4+ years of pharma/biotech late stage clinical development experience and/or is are recognized as a local expert in the field. You have significant experience designing and conducting clinical trials (i.e. one or more trials) You have demonstrated experience in late stage development; you have the proven ability to use sophisticated analytical thought, identify innovative approaches and act a mentor. Preferred: You have drug development experience within SLE and/or other Rheumatologic diseases You have experience publishing results of a scientific study in a peer-reviewed journal You have demonstrated experience working with various clinical trial designs, (e.g. accelerated approval, pivotal, breakthrough etc) You have sound knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process. You have the ability to collaborate with relevant team members to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve such You have strong interpersonal skills: Outstanding interpersonal, verbal, and written communication and influencing skills: has built and cultivated important relationships both inside an organization and externally. Has proven abilities to influence internal partners and stakeholders, thought leaders, national advocacy organizations, national standard-setting bodies, and other relevant external parties. Seamlessly collaborates with colleagues/other parts of the organization. This position is based in South San Francisco, CA or Boston, MA. Relocation benefits are not being offered for this position. The expected salary range for this position based on the primary location of South San Francisco, CA is $233,500 - $433,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits #PDC2025 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $233.5k-433.6k yearly Auto-Apply 20d ago
  • Senior Medical Omnichannel Strategic Excellence Director

    Genentech 4.5company rating

    Medical director job at Genentech

    A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. US Medical, part of Genentech, is passionate about delivering on Our Promise to improve the lives of patients. We foster a culture of inclusivity, integrity, and creativity while boldly pursuing answers to the world's most complex health challenges. To achieve this, Genentech has identified establishing world-class digital medical capabilities as a key priority. The Opportunity We are seeking a results-driven Medical Omnichannel Strategic Excellence Leader to drive a transformative shift in how US Medical engages customers. This leadership role will develop and implement cutting-edge omnichannel capabilities and cultivate a culture of digital excellence. As a strong matrix leader, you will drive behavioral change across US Medical (600+ employees) while compliantly collaborating closely across our Roche functions/partners. As a key leader on the Medical Business Activation cross-functional capability team, you set omnichannel capability priorities, ensuring the solutions built meet the needs of US Medical. Key Responsibilities Increase Medical Customer Engagement with Omnichannel: Significantly enhance the quality, relevance, and impact of our medical interactions with healthcare professionals (HCPs), patients, and other key stakeholders across all touchpoints through the creation and adoption of digital medical capabilities. Shape Future Medical Capabilities & Experience: Proactively identify future capability needs based on evolving medical priorities, setting a strategic activation roadmap to deliver an omnichannel customer experience that maximizes medical impact. Senior Matrix Leadership & Influence: Drive the cultural and operational transformation across Medical, ensuring widespread adoption and successful implementation of our omnichannel and digital strategies. You'll serve as the US Medical Omnichannel lead in all high-level, cross-functional priority-setting discussions. People Leader: manage a direct report and functional service provider team of embedded Medical leads responsible for implementing cross-portfolio & therapeutic area omnichannel programs/tactics and evolving digital capabilities. Who you are Qualifications & Experience 12+ years of relevant healthcare communications, omnichannel strategy/execution, and healthcare experience. Advanced Degree Required (Masters' or higher: MS, MBA, PharmD, PhD or MD) Experience in the Pharmaceutical / Biotech industry, leading large cross-functional teams to achieve strategic objectives and leading across multiple therapeutic areas. Medical Affairs or similar type experience in healthcare functions preferred Omnichannel Expert: Breadth of experience in omnichannel strategies, and advanced ability to define and measure successful medical engagement impact through digital approaches and innovative metrics. Healthcare Ecosystem Expert: Advanced knowledge of the US healthcare ecosystem, regulatory environment, and digital trends. Market & Insights Mastery: Advanced ability to synthesize customer, TA, and market insights to drive strategic medical engagement planning. Cross-Functional Leadership: Proven ability to lead without authority and integrate cross-functional teams to deliver exceptional Customer Experience and build new Medical Capabilities. Location & Travel Requirements This position is based in South San Francisco, CA, and offers a hybrid schedule working in the office 3 days per week. Occasional business travel may be required. The expected salary range for this position based on the primary location of South San Francisco, CA is $214,500 - 398,300. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Relocation benefits are not available for this job posting Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $214.5k-398.3k yearly Auto-Apply 60d+ ago
  • Medical Director, Oncology Early Development

    Genentech 4.5company rating

    Medical director job at Genentech

    We advance science so that we all have more time with the people we love. The Early Clinical Development (ECD) Oncology group at Genentech is seeking a talented Physician-Scientist who is passionate about translating preclinical discoveries into the next generation of cancer therapies to benefit patients. The Opportunity: This role focuses on the clinical trial development of innovative anti-cancer therapies across Genentech's diverse portfolio, which includes large molecules (monoclonal antibodies, T-cell engagers, antibody drug conjugates), small molecules, cytokines, vaccines, and allogeneic cellular therapies. The scope encompasses initial first-in-human (Phase I) trials through proof-of-concept (Phase II) studies to enable decisions regarding initiation of pivotal (Phase III) studies and the initial scope of late stage development. The Medical Director will provide clinical leadership to a number of cross-functional teams to drive the design, implementation, monitoring, analysis, and reporting of studies conducted within one or more programs. Key responsibilities include external communication with experts and investigators, and contributing to the development of comprehensive “end-to-end” strategic program plans through collaboration with various Genentech groups (Research, Translational Medicine, Late-stage Product Development and Product Strategy). Additionally, this role may involve providing clinical insights to Pharma Partnering for potential Business Development opportunities. Who You Are: Requirements for the position include the following. The level of the position will depend on the qualifications of the selected candidate. M.D. with board certification, or eligibility, in Oncology, Hematology/Oncology, or related specialties M.D./Ph.D. is a plus Ideally 0-2 years of industry experience in oncology or comparable clinical trial experience in an academic setting Excellent scientific record with experience in laboratory-based cancer research and/or oncology clinical trials within an academic institution or the biopharmaceutical industry Capability and eagerness to contribute effectively within multi-disciplinary teams Ability to interact with external experts and investigators effectively Excellent written and verbal communication skills Relocation benefits are available for this posting. Onsite presence, on our South San Francisco campus, is expected for at least 3 days a week. The expected salary range for this position based on the primary location of South San Francisco, California is $213,400 - $396,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits #LI-JD1 #ECD Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $213.4k-396.2k yearly Auto-Apply 60d+ ago
  • Medical (Science) Director, Breast & Gyn Cancer

    Genentech 4.5company rating

    Medical director job at Genentech

    A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. The Opportunity In this role, you will be required to perform one or more of the following activities depending upon areas of expertise or assignment to specific activities, molecules, or disease/therapeutic areas: Responsibilities Design, execute, and monitor medical strategies, plans, and tactics spanning the lifecycle, including clinical data generation design and management Engage in thought leader interactions, sponsor and support trials, and manage registries and exploratory data analysis Build and review medical content, and engage in scientific congress planning and support Evaluate, synthesize, and visualize clinical and economic data, and develop written scientific communication Identify access-related medical issues and opportunities, monitor adverse events, and contribute clinically meaningful perspective for regulatory and other scientific communications Act as a medical lead for study design, data interpretation, and medical content development, and collaborate with internal and external stakeholders for insights generation Implement medical strategy through tactics and contribute medical expertise to Genentech work products while maintaining an in-depth understanding of relevant medical strategy and clinical landscape Who you are Qualifications & Experience 3+ years of pharmaceutical/biotechnology relevant industry experience preferred - preferably in Medical Affairs or product development or is a recognized expert in the field or therapeutic area (with a minimum of 2 years' clinical experience) MD, PharmD or PHD Understanding of and/or previous experience with Phase I - III and/or Phase IV drug development Considerable experience in the principles and techniques of data analysis, interpretation and clinical relevance, and medical writing Proven track record of meeting or exceeding objectives and goals Preferred Experience Experience in Breast/GYN Cancer Strong academic/teaching background Proven record in developing strong relationships with external constituents (therapeutic area experts, external organizations, etc.) The expected salary range for this position based on the primary location of South San Francisco, California is $142,200 - 264,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Relocation benefits are not available for this job posting. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $142.2k-264.2k yearly Auto-Apply 3d ago
  • US Medical Senior Director, Medical Affairs Evidence Generation

    Gilead Sciences, Inc. 4.5company rating

    Santa Monica, CA jobs

    We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. **Job Description** At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. The US Medical Senior Director, MA Evidence Generation at Kite Pharma, a Gilead Company, will provide scientific and strategic leadership for the design, execution, and interpretation of medical evidence generation activities supporting Kite's portfolio of innovative cell therapies. This role is central to shaping Kite's evidence ecosystem, driving innovation, and supporting and aligning priorities within the Integrated Evidence Generation Plan balancing regional and global medical strategies. The ideal candidate is an experienced clinical leader with extensive therapeutic expertise, a proven track record in collaborative trial design and management, and a passion for transforming patient outcomes. **Location:** Santa Monica, CA (preferred) or Foster City, CA **Key Responsibilities** **Strategic Evidence Planning** + Serve as a senior member of the Evidence Generation (EG) leadership team, co-driving the evolution of Kite's US evidence generation strategy and value proposition + Support the development and execution of the Integrated Evidence Plan (IEP) for Kite assets in collaboration with the entire Evidence Generation Function, Global Medical Affairs Strategy and Product Teams. + Provide leadership to support the identification of critical evidence gaps and define the most appropriate research approaches (e.g., retrospective, prospective, interventional, RWE) to address the unmet needs. **Study Oversight and Execution** + Provide scientific and medical oversight for all Medical Affairs / Kite Sponsored Studies including interventional trials, non-interventional studies, and US Strategic Alliances. + Lead the development of clinical study concepts, protocols in collaboration with Medical and Clinical development teams. + Oversee the US Investigator-Sponsored Research (ISR) and Collaborative Research (CR) program within the evidence generation strategy, ensuring scientific merit, alignment with strategic priorities, and compliance. + Serve as the Medical Monitor for assigned evidence generation studies, ensuring timely execution, data quality, and compliance with all relevant regulations (GCP, internal SOPs). + Provide strategic oversight and clinical guidance to operational teams to ensure timely and impactful execution. **Data Interpretation and Dissemination** + Lead the medical review, interpretation, and communication of study results, including drafting publications, abstracts, posters, and internal/external presentations. + Serve as a medical expert for study data, engaging with internal and external stakeholders and external Key Opinion Leaders (KOLs). + Collaborate with Global Medical Strategy to ensure accurate and compliant dissemination of generated evidence. **Cross-Functional Collaboration and Compliance** + Partner across Kite Medical Affairs, Clinical Development, Translational Medicine, Regulatory Affairs, and Product Teams to build integrated cross-functional capabilities + Mentor and provide guidance to team members and cross-functional partners on evidence generation best practices, methodologies, and compliance requirements. + Ensure all evidence generation activities are conducted in strict adherence to Kite/Gilead policies, local regulations, and the highest ethical standard and where necessary lead the development of the appropriate processes and systems. + Design and implement strategies to accelerate evidence generation through external platforms, technologies, and data-driven insights. + Represent the Evidence Generation function at core Kite governance bodies (e.g., Product Teams, Global Medical Teams, JSC), advising on external opportunities and informing and making strategic decisions. **Scientific Engagement** + Champion medical innovation by integrating emerging scientific trends and technologies into US evidence generation strategies. + Lead external engagement efforts to enhance scientific credibility and foster meaningful partnerships with healthcare professionals and institutions. + Serve as a member of the central External Research Program screening/review committee and manage joint steering committees for strategic collaborations. **Qualifications** **Required** + MD or equivalent medical degree. + Minimum of 5 years of experience in the biopharmaceutical industry, with at least 5 years in medical affairs, clinical development, or evidence generation roles. + Proven leadership in designing and managing clinical trials, including Phase IV and investigator-sponsored studies. + Understanding of the cell therapy landscape, including regulatory and post-approval evidence needs. **Preferred** + Experience in CAR-T or related advanced modalities (e.g., gene therapy, immuno-oncology). + Demonstrated success in leading teams and cross-functional teams and external partnerships. + Strong strategic thinking, project management, and stakeholder engagement and influencing skills. + Familiarity with digital platforms and real-world data methodologies. **Other Requirements** + Willingness to travel domestically up to 20-30%. + Strong communication and stakeholder management skills. **People Leader Accountabilities:** + Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. + Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. + Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: Other US Locations: $255,425.00 - $330,550.00. Bay Area: $281,010.00 - $363,660.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit ****************** . Sign up to follow @KitePharma on Twitter at ************************** . **For jobs in the United States:** Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (********************************************************* YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. **For Current Kite Pharma Employees and Contractors:** Please apply via the Internal Career Opportunities portal in Workday. **Change The World With Us** Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted. While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
    $281k-363.7k yearly 4d ago
  • Assoc Director, Medical Affairs

    Gilead Sciences 4.5company rating

    Foster City, CA jobs

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, CA, Gilead has operations in North America, Europe, Asia, and Australia. For more information, please visit Gilead.com. We have an exciting opportunity within the US Medical Affairs (USMA) organization for an Associate Director within Oncology Medical Strategy. Reporting to Executive Director of USMA Oncology Strategy, this role will be responsible for providing Medical support to the development and execution of the USMA strategic and tactical plans in collaboration with the broader US and Global Medical Affairs teams. Specific Job Responsibilities Collaborates with oncology therapeutic area leads in the execution of core Medical tactics, including content development, Medical Regulatory Compliance (MRC) reviews, advisory board planning, stakeholder engagement planning, medical congresses, and data generation efforts Serves as the Medical Strategy point-of-contact for the Gilead Medical Science Liaison (MSL) team to provide training, interpret insights, and support overall Field Medical strategy Creates and maintains Gilead Oncology Pipeline materials across tumor types in collaboration with Global Medical Affairs, Clinical Development, Alliance Management, and the broader US Medical Affairs team Provide clinical and scientific input on Independent Medical Education, Grants and / or Investigator-Sponsored Research / Collaborative Research, and Medical Information response documents for oncology products / pipeline molecules, as needed Demonstrates strong project management / execution skills to ensure the successful delivery of the Local Strategic Plan (strategy plan) and Medical Plan of Action (tactical plan), amongst other projects as assigned Lead USMA encore publications strategy and execution for impactful oncology data / evidence in collaboration with Global Publications team Proactively drives initiatives to completion, anticipating obstacles and difficulties that may arise and resolving them in a positive, collaborative manner Works collaboratively with Gilead personnel across Medical Affairs, Clinical Development, Commercial, Market Access, Heath Economics & Outcomes Research, Real World Evidence, and Global Safety Attends major and disease-specific congresses to coordinate USMA activities with internal and external stakeholders and represents Gilead Oncology, including the presentation of clinical / scientific information to external audiences National and international travel, including overnight and weekends as required Basic Qualifications Bachelor's Degree and Ten Years' Experience OR Master's Degree and Eight Years' Experience OR PhD, PharmD and Five Years' Experience OR MD and Two Years' Experience Preferred Qualifications PhD, PharmD, or MD strongly preferred with pharmaceutical, clinical, or research experience in oncology therapeutic area Prior US, Global, or large affiliate experience in Oncology Medical Affairs Industry experience with knowledge of all applicable regulatory and legal requirements for Medical Affairs activities Excellent written, verbal, presentation, interpersonal, relationship-building, and negotiating communication competencies Superior analytical skills to identify complex challenges and interpret key findings from study data and publications Strong organizational skills, attention to detail, and ability to meet timelines in a fast-paced environment with a high level of autonomy and independence Experience working in a highly matrixed organization with a proven ability to build internal relationships, manage stakeholders, prioritize work appropriately, and manage workload while delivering results Ability to shape positive dialogues, influence outcomes, and respectfully challenge a group of experts People Leader Accountabilities Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage their teams Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: Bay Area: $195,670.00 - $253,220.00. Other US Locations: $177,905.00 - $230,230.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
    $195.7k-253.2k yearly Auto-Apply 31d ago
  • Executive Medical Director, Obesity

    Amgen 4.8company rating

    Thousand Oaks, CA jobs

    **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. 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. **Executive Medical Director, Obesity** **Live** **What you will do** Let's do this. Let's change the world. The Obesity organization is seeking an Executive Medical Director that will oversee a team of physician-scientists that support evidence generation for obesity and obesity-related conditions, as well as supporting and reporting into the Vice President, Obesity. **Responsibilities** + Provide clinical/scientific knowledge into the development, design, delivery and communication of the global evidence generation plan for multiple metabolic assets. + Support (and lead when requested) cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program + Participate and provide clinical input into safety and regulatory interactions + Interpret and communicate clinical trial data + Oversee the authoring of clinical study reports, publications and regulatory submissions + Develop relationships with key opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated the Vice President. + Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization + Contribute to TPP (target product profile) and Global Product Safety (GPS) development + Create development options and present to Global Dev Review Committee (GDRC), Therapeutic Area Governance (TAG), and Portfolio Governance. + Interact with TA leadership and extended team to develop strategics options + Interact and collaborate with Center for Design Analysis (CfDA), Center for Observational Research (CfOR), Clinical Pharmacology Modeling & Simulation (CPMS), etc., to bring innovative later development options. + Provide clinical and scientific input to business development interactions including due diligence processes. **Win** **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The executive candidate we seek is an experienced leader with the following qualifications. **Basic Qualifications:** + MD or DO degree from an accredited medical school AND + Five years of industry or academic research AND + 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resource **Preferred Qualifications:** + Five (5) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) in obesity or obesity-related conditions. + Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities + Previous experience in regulatory interactions. + Strong and versatile clinical development experience in endocrinology and accreditation in relevant sub-specialty + Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes + Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1, 2 and/or 3 clinical trials in obesity or diabetes + Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements + Leadership experience/potential as a medical expert in a complex matrix environment + Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication + Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path They will also embody the Amgen leadership attributes which are: + **Inspire:** Create a connected, inclusive, and inspiring work environment that empowers talent to thrive + **Accelerate:** Enable speed that matches the urgency of patient needs by encouraging progress over perfection + **Integrate:** Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders + **Adapt:** Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results **Thrive** **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 annual base salary range for this opportunity in the U.S. is $343,334 - $403,728. 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: + 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 and bi-annual company-wide shutdowns + Flexible work models, including remote work arrangements, where possible 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 with 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. 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.
    $343.3k-403.7k yearly 60d+ ago
  • Executive Medical Director, Obesity

    Amgen 4.8company rating

    Thousand Oaks, CA jobs

    Career CategoryClinical DevelopmentJob 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. 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. Executive Medical Director, Obesity Live What you will do Let's do this. Let's change the world. The Obesity organization is seeking an Executive Medical Director that will oversee a team of physician-scientists that support evidence generation for obesity and obesity-related conditions, as well as supporting and reporting into the Vice President, Obesity. Responsibilities Provide clinical/scientific knowledge into the development, design, delivery and communication of the global evidence generation plan for multiple metabolic assets. Support (and lead when requested) cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program Participate and provide clinical input into safety and regulatory interactions Interpret and communicate clinical trial data Oversee the authoring of clinical study reports, publications and regulatory submissions Develop relationships with key opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated the Vice President. Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization Contribute to TPP (target product profile) and Global Product Safety (GPS) development Create development options and present to Global Dev Review Committee (GDRC), Therapeutic Area Governance (TAG), and Portfolio Governance. Interact with TA leadership and extended team to develop strategics options Interact and collaborate with Center for Design Analysis (CfDA), Center for Observational Research (CfOR), Clinical Pharmacology Modeling & Simulation (CPMS), etc., to bring innovative later development options. Provide clinical and scientific input to business development interactions including due diligence processes. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The executive candidate we seek is an experienced leader with the following qualifications. Basic Qualifications: MD or DO degree from an accredited medical school AND Five years of industry or academic research AND 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resource Preferred Qualifications: Five (5) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) in obesity or obesity-related conditions. Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities Previous experience in regulatory interactions. Strong and versatile clinical development experience in endocrinology and accreditation in relevant sub-specialty Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1, 2 and/or 3 clinical trials in obesity or diabetes Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements Leadership experience/potential as a medical expert in a complex matrix environment Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path They will also embody the Amgen leadership attributes which are: Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results Thrive 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 annual base salary range for this opportunity in the U.S. is $343,334 - $403,728. 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: 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 and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible 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 with 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. 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. . Salary Range 343,334.00 USD - 403,728.00 USD
    $343.3k-403.7k yearly Auto-Apply 26d ago
  • Medical Sciences Director - Late Development, Sotorasib

    Amgen 4.8company rating

    Thousand Oaks, CA jobs

    Career CategoryClinical DevelopmentJob DescriptionJoin 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. 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. Medical Sciences Director - Late Development, Sotorasib What you will do Let's do this. Let's change the world. In this vital role you will contribute to late phase clinical development of oncology. The Medical Science Director will collaborate on teams to define, design, and deliver late phase clinical results, supplemented by translational projects in the ongoing strategy for drug development. Through their role, the Medical Science Director provides subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer. The Medical Science Director supports experimental design and clinical data review in late phase clinical trials. Serve as an internal clinical expert in translational and clinical oncology Collaborate with medical monitor to support clinical trial level activities Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams Provide guidance and assistance in the identification and management of oncology collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents. Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval. Provide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results. Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 4 years of life sciences/healthcare experience OR Master's degree and 7 years of life sciences/healthcare experience OR Bachelor's degree and 9 years of life sciences/healthcare experience Preferred Qualifications: 5 years of pharmaceutical clinical drug development experience Strong preference for individuals with proven track record of oncology clinical trial process improvement Industry or academic experience in late-phase oncology drug development Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally (both written and oral) Experience with designing, monitoring, and implementing oncology clinical trials and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions Serving as a contributing author to scientific publications and data presentations at scientific conferences Experience in clinical data analysis such as Spotfire or other data analysis tools 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, including remote and hybrid work arrangements, where possible 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. 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 211,263.00 USD - 251,166.00 USD
    $243k-341k yearly est. Auto-Apply 60d+ ago
  • Medical Director - US Medical Lead - Evenity (Bone)

    Amgen 4.8company rating

    Thousand Oaks, CA jobs

    Career CategoryMedical AffairsJob DescriptionJoin 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. 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. Medical Director, US Medical LeadWhat you will do Let's do this. Let's change the world. In this vital role you will support implementation of US medical Strategies. Supporting the development and execution of US product medical strategy, via the US Medical Plan, including launch support and lifecycle management, in collaboration with Product Team/Portfolio Governance and alignment with Global strategy Supporting definition of scientific evidence gaps, development of local evidence generation strategy in coordination with Global Supporting clinical trial conduct Participating in engagement of external key stakeholders (often in partnership with other functions) Participating in development of data communication strategy (including congress) Supports Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data Supports implementation of Medical governance for respective product, which includes: Safety and pharmacovigilance as a key and effective partner with GRAAS Clinical trial conduct US risk management/minimization in collaboration with GRAAS Subject matter appropriateness (medical/scientific) of external interactions (e.g. copy review, multichannel, congresses, 1-1 interactions, etc. Ensuring appropriate medical support of compliance What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Medical Lead we seek is a collaborative leader with these qualifications. Basic Qualifications: Doctorate degree and 4 years of medical leadership experience Or Master's degree and 8 years of medical leadership experience Or Bachelor's degree and 10 years of medical leadership experience In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: MD plus accredited fellowship, board certified or board eligible Clinical research/medical affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers Experience with clinical study management and conduct Familiarity with US health care compliance considerations Experience with opinion leader interactions Experience with integrated delivery networks, accountable care organizations, and payers Broad and formal leadership experience 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 Network of customer contacts in therapeutic area Knowledge of local pharmaceutical industry and legal/health system environment 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, including remote and hybrid work arrangements, where possible 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. 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 240,754.00 USD - 277,917.00 USD
    $243k-341k yearly est. Auto-Apply 60d ago
  • Medical Director, Radiopharmaceutical Imaging (RPI)

    Bristol-Myers Squibb 4.6company rating

    San Diego, CA jobs

    Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals . The Medical Director RPI has responsibility for the development of RayzeBio's diagnostic imaging pipeline across disease areas, including but not limited to prostate cancer, hepatocellular cancer and neuroendocrine tumors. Responsibilities may include support for IND preparation, regulatory authority interactions, design, and execution of Phase 0 to Phase 3 clinical trials, and medical monitoring. This role provides medical direction and high quality scientific and clinical knowledge to guide the strategy and execution of RayzeBio's diagnostic imaging portfolio. This role works collaboratively with multi-disciplinary teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within RayzeBio's portfolio to ensure the program meets the needs of patients and RayzeBio's business. Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Interact with clinical investigators and thought leaders to design a diagnostic imaging strategic plan for nominated candidates Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies of radiopharmaceutical imaging agents. Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets Translate findings from research and nonclinical studies into diagnostic imaging development opportunities Oversee Data Review and Independent Data Monitoring Committees as applicable Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines Establish and maintain positive relationships with clinical trial investigators and thought leaders Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings. Work closely with commercial and medical affairs organization to develop and execute on a diagnostic imaging program for RayzeBio portfolio in radiopharmaceutical imaging. Willing to travel approximately 30% of the time. Evening and weekend work will be involved. Education and Experience MD or equivalent with at least 5 years of pharmaceutical, biotech experience or academic clinical experience in oncology diagnostic development or 3 years' experience for candidates with track record of developing radiopharmaceutical imaging agents through a regulatory process. Skills and Qualifications Patient-focused, with deep commitment to understanding needs and improving the lives of patients with cancers and a passion for developing novel therapeutics Motivated to work in a fast-paced, high accountability, and small company environment. A "can do" and collegial professional who leads through influence and interpersonal skills. Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering deadlines with high performance standards and attention to detail. Demonstrated ability to collaborate successfully with multiple functions in a team environment. Intellectually curious with courage to challenge and seek new ways to improve work. Strong written and oral communication skills, including presentation skills. Ability to analyze and interpret data and develop written reports and presentations of those data. Strong critical, strategic, and analytical thinking skills. Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis, and reporting. Experience working closely with investigative sites, including principal investigators, sub- investigators, study coordinators, and other site personnel involved in clinical trials. Skilled in clinical research and understands the process of radiopharmaceutical imaging agent development and approval. Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP's). Solid understanding of GCP and ICH guidelines. Physical demands While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision. Work Environment The noise level in the work environment is usually moderate. #RayzeBio If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Remote - United States - US: $265,740 - $322,014 San Diego - RayzeBio - CA: $286,999 - $347,775 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
    $287k-347.8k yearly Auto-Apply 27d ago
  • Medical Director, Radiopharmaceutical Imaging (RPI)

    Bristol Myers Squibb 4.6company rating

    San Diego, CA jobs

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals . The Medical Director RPI has responsibility for the development of RayzeBio's diagnostic imaging pipeline across disease areas, including but not limited to prostate cancer, hepatocellular cancer and neuroendocrine tumors. Responsibilities may include support for IND preparation, regulatory authority interactions, design, and execution of Phase 0 to Phase 3 clinical trials, and medical monitoring. This role provides medical direction and high quality scientific and clinical knowledge to guide the strategy and execution of RayzeBio's diagnostic imaging portfolio. This role works collaboratively with multi-disciplinary teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within RayzeBio's portfolio to ensure the program meets the needs of patients and RayzeBio's business. **Job Responsibilities** Essential duties and responsibilities include the following. Other duties may be assigned. + Interact with clinical investigators and thought leaders to design a diagnostic imaging strategic plan for nominated candidates + Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies of radiopharmaceutical imaging agents. + Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents + Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators + Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets + Translate findings from research and nonclinical studies into diagnostic imaging development opportunities + Oversee Data Review and Independent Data Monitoring Committees as applicable + Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines + Establish and maintain positive relationships with clinical trial investigators and thought leaders + Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings. + Work closely with commercial and medical affairs organization to develop and execute on a diagnostic imaging program for RayzeBio portfolio in radiopharmaceutical imaging. + Willing to travel approximately 30% of the time. Evening and weekend work will be involved. **Education and Experience** + MD or equivalent with at least 5 years of pharmaceutical, biotech experience or academic clinical experience in oncology diagnostic development or 3 years' experience for candidates with track record of developing radiopharmaceutical imaging agents through a regulatory process. **Skills and Qualifications** + Patient-focused, with deep commitment to understanding needs and improving the lives of patients with cancers and a passion for developing novel therapeutics + Motivated to work in a fast-paced, high accountability, and small company environment. A "can do" and collegial professional who leads through influence and interpersonal skills. + Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering deadlines with high performance standards and attention to detail. + Demonstrated ability to collaborate successfully with multiple functions in a team environment. + Intellectually curious with courage to challenge and seek new ways to improve work. + Strong written and oral communication skills, including presentation skills. + Ability to analyze and interpret data and develop written reports and presentations of those data. + Strong critical, strategic, and analytical thinking skills. + Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis, and reporting. + Experience working closely with investigative sites, including principal investigators, sub- investigators, study coordinators, and other site personnel involved in clinical trials. + Skilled in clinical research and understands the process of radiopharmaceutical imaging agent development and approval. + Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP's). + Solid understanding of GCP and ICH guidelines. **Physical demands** While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision. **Work** **Environment** The noise level in the work environment is usually moderate. \#RayzeBio If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. **Compensation Overview:** Remote - United States - US: $265,740 - $322,014 San Diego - RayzeBio - CA: $286,999 - $347,775 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. **Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site Protocol** BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to ************************** . Visit careers.bms.com/ (****************************************** eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1597090 **Updated:** 2025-12-14 00:51:16.402 UTC **Location:** San Diego-CA Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
    $287k-347.8k yearly 25d ago
  • Assoc Medical Director, Cardiac Imaging

    J&J Family of Companies 4.7company rating

    Irvine, CA jobs

    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. Learn more at ******************* **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical Affairs **Job Category:** Scientific/Technology **All Job Posting Locations:** Irvine, California, United States of America **Job Description:** **About MedTech** Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech This is a [hybrid] role available in Irvine, CA. We invite candidates from any location to apply. We are searching for the best talent for **Associate Medical Director, Cardiac Imaging.** **Role Purpose** The Associate Medical Director will be involved in the strategic development and growth of the Cardiac Imaging portfolio and engage in partnership with Research and Development (R&D), Global Strategic Marketing (GSM), Health Economics and Market Access (HEMA), and Clinical Affairs (CA). Associate Medical Director, under limited supervision, in collaboration with MA team members and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position's responsibilities include, but are not limited to: + Support the generation of preclinical and clinical evidence strategies to support clinical claims and participate in characterizing the products capabilities and clinical workflows in collaboration with R&D, marketing, and other development team members. + Partner with Clinical Research (and other partners, e.g., Regulatory Affairs) in the development and execution of product and/or procedural evidence generation (including company sponsored studies and IIS/RWE) and dissemination strategies. + Support early product introduction to the market by supporting launches, case support, as well as internal and external training. + Provide medical oversight of publication strategy for selected marketed products in close collaboration with the Clinical Science team. + Prepare and/or manage preparation of presentations and manuscripts around clinical data as well as medical and scientific information, this includes hands on management of publications and maintenance of timelines + Optimize communication and interactions with key customers/KOL and accounts by working with strategic managers within Medical Scientific Programs, Account Management and Sales teams + Assist in the tactical implementation of regional and local educational initiatives in concert with corporate and regional business goals + Gain valuable insight and feedback from the healthcare community on Cardiac Imaging products and services, medical and scientific information which can help guide research, development and service provision to benefit customers and patients as well as supporting internal stakeholders + Perform other duties assigned as needed **Qualifications** **What you will bring:** **Education:** + A degree in science, engineering, or medicine (e.g. MD, DO, PhD, RN, MSc, BSc, etc.) is required. **Experience and Skills:** + A strong scientific background is preferred + Minimum 7 years relevant experience in medical affairs/related functions (e.g. clinical, R&D, regulatory, medical safety) is required. + A minimum of 3 years in echocardiography clinical experience is required + Structural heart imaging including transesophageal OR intracardiac echocardiography, computed tomography experience is required. + Clinical experience with medical devices and knowledge of clinical trial design, evidence generation, adverse event reporting, transcatheter interventional procedure practices/principles is required. + Relevant business experience in product development for Cardiac imaging. Experience with structural heart imaging preferred. + Experience supporting clinical cases and proctoring cases preferred. + Strong influencing, negotiation skills with different types of internal and external stakeholders. + Must be able to collaborate well with multiple partners and work effectively in a matrix environment. + Demonstrated success in medical data generation, interpretation and publications is highly preferred. + Strong scientific communication skills (written and verbal). + Sound understanding on Good Clinical Practices and SOPs + Self-starter with proven ability to collaborate in a cross-functional team environment while having the skillset and confidence to work independently, as needed + Must be reliable, and flexible in adapting to shifting business needs while contributing to a multidisciplinary and fast-paced working environment + Must be a highly motivated, responsible, fast-learner, and team-oriented collaborator willing to take ownership of his/her contributions to the advancement of the collective team goals and objectives + Ability and willingness to travel up to 50% of the time for hands-on testing, product initiation and conferences. + Proficient in Microsoft Office The anticipated base pay range for this position is 137,000 - 235,750. At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through innovative programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love! At Johnson & Johnson, we offer a variety of outstanding health and financial benefits, including competitive compensation, 401k, pension, medical, dental, and vision insurance, exercise reimbursement, flexible time off, paid volunteer and parental leave, and more! For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ******************* . 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. _Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation,_ **_external applicants please contact us via_** **_*******************/contact-us/careers_** **_. internal employees contact AskGS to be directed to your accommodation resource._** \#PULSE #EP **Required Skills:** **Preferred Skills:** **The anticipated base pay range for this position is :** 137,000 - 235,750 Additional Description for Pay Transparency: The anticipated base pay range for this position is 137,000 - 235,750
    $218k-311k yearly est. 60d+ ago
  • Medical Director, Cardiac Imaging

    J&J Family of Companies 4.7company rating

    Irvine, CA jobs

    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. Learn more at ******************* **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical Affairs **Job Category:** People Leader **All Job Posting Locations:** Irvine, California, United States of America **Job Description:** **About MedTech** Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech This is a [hybrid] role available in Irvine, CA. We invite candidates from any location to apply. We are searching for the best talent for **Medical Director, Cardiac Imaging** . **Role Purpose** The Director will have medical affairs responsibility in providing therapeutic and clinical expertise in support of the development of cardiac imaging for the treatment of structural heart diseases. This position will play a pivotal role in shaping the medical direction of our NuVision 4D ICE Technology, ensuring compliance with regulatory standards and driving innovation in medical technology development. This role will provide strong strategic input on long term product opportunities and portfolio strategies related to cardiac imaging, work closely with the Clinical Research team in support of evidence generation and dissemination activities that support product approvals, claims development, and product adoption and lifecycle management, and work closely with the R&D teams during product development and with marketing and commercial teams during product launches to provide training and education. The Director will help shape the industry and build strong relationships externally with key customers and stakeholders (Key Opinion Leaders, Echocardiographers, Interventional Cardiologists, Electrophysiologists, Regulatory Agencies, Professional Societies, etc.) to anticipate industry trends, understand clinical/medical insights, unmet medical needs and global standards of care to deliver quality products/solutions. **What you will be doing:** **Clinical Leadership** + Lead the support for all clinical studies - both for regulatory purposes as well as physician initiated collaborative studies. They will be responsible and accountable for case support plan and execution, physician training, internal field training, training materials, data analysis, publication support and collection of data for supporting platform claims. + Contribute to the development and execution of product and/or procedural evidence generation and dissemination strategies for company sponsored and investigator initiated research. + Collaborate with evidence generation colleagues from Preclinical Research and Clinical Research teams in the USA and internationally to develop global strategies for evidence generation for new and existing products in order to support regulatory approval/clearance, health technology assessment, customer access and post-marketing support + Provide scientific expertise, oversight and approval for clinical trial concept, design, analysis and reporting of clinical research in assigned areas + Provide oversight for the development of materials to be used for study execution (investigator brochures, training materials, etc.) + Work closely with Medical Safety team to ensure adverse events from clinical research studies are reviewed, trended and escalated as needed + Provide scientific input and expertise in the analysis of study results + Work with Regulatory and Clinical partners to prepare report on clinical investigations in preparation for submission to regulatory agencies and/or for publication, to meet evidence requirements + Account for the medical content of internal product documentation and regulatory submissions for new products and for renewals. + Safeguard patient safety. + Approve Design History Files, Technical Guides and Clinical Evaluation Reports (CERs) as part of the creation of product-specific design dossiers/technical files + Review and approve educational, promotional and reporting materials for use by internal stakeholders. + Strategize and prioritize publication proposals in collaboration with Clinical Science. **Cross Function Collaborations** + Work with business partners including but not limited to R&D, Clinical Research, Business Development, Regulatory Affairs, Quality & Compliance, Health Economics & Market Access, and Professional Medical Education to influence overall regulatory and commercial strategy, as well as support product development, pre- and post-approval clinical studies, downstream claims, safety assessments, and product launch and training. + Have a leadership role in governance forums including Business Unit leadership teams, cross-functional product core teams, EGS teams, portfolio/strategy management teams, and Safety and Quality Review Boards. + Support the commercial launch of the platform by activating sites, providing physician training, and collect regular feedback on product performance and improvements. + Provide support to Marketing, R&D, Communications, Legal, Quality Assurance/Risk Management/Product Safety and Commercial teams by providing medical and scientific insights to drive optimal business strategic direction and tactical business activities **External Engagements** + Engage Key Opinion leaders, Professional Societies, Payers and Providers to understand trends in care and uncover critical insights to support product innovation + Develop relationships with top academic leaders who are investigating Cardiac Imaging + Collaborate with other functions interacting with Cardiac Imaging customers / physicians + Ability and willingness to travel up to 35% of the time **Program Oversight and Team Development** + Align strategy, budget and resource allocation in close partnership with the cross-functional partners. + Recruit, mentor, and support the professional growth of the Cardiac Imaging Medical Affairs team + Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition + Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures **Qualifications** **Education** + A degree in medicine (MD, DO, etc.) with training in Cardiology is required. **Experience and Skills:** + Minimum 10 years relevant experience in related studies such as: Cardiac Imaging, Echocardiography, Structural Heart Imaging + Relevant business experience in product development for Cardiac imaging. Experience with Structural Heart imaging is highly desired. + Cardiovascular industry and cardiac imaging knowledge strongly preferred with proven ability to learn complex technology/clinical applications. + Significant experience with clinical research is required. + Strong leadership skills and demonstrated ability to build successful relationships with internal and external partners globally is required. + Prior people management experience is required. + Demonstrated capability, expertise and success in building teams to meet the needs of a global set of businesses is desirable. + Strong communication and negotiation skills to successfully influence and implement policy with key customers and partners is essential. + Must be able to collaborate well with multiple partners and work effectively in a matrix environment. + Previous industry experience leading Medical/Clinical teams in a regulated, commercial biomedical or medical device business is strongly preferred + Experience in product risk evaluation and mitigation is preferred. + Demonstrated success in medical data generation, interpretation and publications is highly preferred. + A willingness and ability to travel approximately 35% domestic and international is required. The anticipated base pay range for this position is 160,000 - 276,000. At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through innovative programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love! At Johnson & Johnson, we offer a variety of outstanding health and financial benefits, including competitive compensation, 401k, pension, medical, dental, and vision insurance, exercise reimbursement, flexible time off, paid volunteer and parental leave, and more! For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ******************* . 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. _Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation,_ **_external applicants please contact us via_** **_*******************/contact-us/careers_** **_. internal employees contact AskGS to be directed to your accommodation resource._** **_\#PULSE #EP_** **Required Skills:** **Preferred Skills:** **The anticipated base pay range for this position is :** $164,000.00 - $282,900.00 Additional Description for Pay Transparency:
    $164k-282.9k yearly 60d+ ago
  • Medical Director, Structural Heart

    J&J Family of Companies 4.7company rating

    Irvine, CA jobs

    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. Learn more at ******************* **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical Affairs **Job Category:** People Leader **All Job Posting Locations:** Irvine, California, United States of America **Job Description:** **About MedTech** Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech This is a [hybrid] role available in Irvine, CA. We invite candidates from any location to apply. We are searching for the best talent for **Medical Director, Structural Heart** . **Role Purpose** The Director will have medical affairs responsibility in providing therapeutic and clinical expertise in support of the development of medical devices for the treatment of structural heart diseases. This position will play a pivotal role in shaping the medical direction of our structural heart business, ensuring compliance with regulatory standards and driving innovation in medical technology development. This role will provide strong strategic input on long term product opportunities and portfolio strategies related to structural heart interventions, work closely with the Clinical Research team in support of evidence generation and dissemination activities that support product approvals, claims development, and product adoption and lifecycle management, and work closely with the R&D teams during product development and with marketing and commercial teams during product launches to provide training and education. The Director will help shape the industry and build strong relationships externally with key customers and stakeholders (Key Opinion Leaders, Interventional Cardiologists, Regulatory Agencies, Professional Societies, etc.) to anticipate industry trends, understand clinical/medical insights, unmet medical needs and global standards of care to deliver quality products/solutions. **What you will be doing:** **Clinical Leadership** + Lead the support for all clinical studies - both for regulatory purposes as well as physician initiated collaborative studies. They will be responsible and accountable for case support plan and execution, physician training, internal field training, training materials, data analysis, publication support and collection of data for supporting platform claims. + Contribute to the development and execution of product and/or procedural evidence generation and dissemination strategies for company sponsored and investigator initiated research. + Collaborate with evidence generation colleagues from Preclinical Research and Clinical Research teams in the USA and internationally to develop global strategies for evidence generation for new and existing products in order to support regulatory approval/clearance, health technology assessment, customer access and post-marketing support + Provide scientific expertise, oversight and approval for clinical trial concept, design, analysis and reporting of clinical research in assigned areas + Provide oversight for the development of materials to be used for study execution (investigator brochures, training materials, etc.) + Work closely with Medical Safety team to ensure adverse events from clinical research studies are reviewed, trended and escalated as needed + Provide scientific input and expertise in the analysis of study results + Work with Regulatory and Clinical partners to prepare report on clinical investigations in preparation for submission to regulatory agencies and/or for publication, to meet evidence requirements + Account for the medical content of internal product documentation and regulatory submissions for new products and for renewals. + Safeguard patient safety. + Approve Design History Files, Technical Guides and Clinical Evaluation Reports (CERs) as part of the creation of product-specific design dossiers/technical files + Review and approve educational, promotional and reporting materials for use by internal stakeholders. + Strategize and prioritize publication proposals in collaboration with Clinical Science. **Cross Function Collaborations** + Work with business partners including but not limited to R&D, Clinical Research, Business Development, Regulatory Affairs, Quality & Compliance, Health Economics & Market Access, and Professional Medical Education to influence overall regulatory and commercial strategy, as well as support product development, pre- and post-approval clinical studies, downstream claims, safety assessments, and product launch and training. + Have a leadership role in governance forums including Business Unit leadership teams, cross-functional product core teams, EGS teams, portfolio/strategy management teams, and Safety and Quality Review Boards. + Support the commercial launch of the platform by activating sites, providing physician training, and collect regular feedback on product performance and improvements. + Provide support to Marketing, R&D, Communications, Legal, Quality Assurance/Risk Management/Product Safety and Commercial teams by providing medical and scientific insights to drive optimal business strategic direction and tactical business activities **External Engagements** + Engage Key Opinion leaders, Professional Societies, Payers and Providers to understand trends in care and uncover critical insights to support product innovation + Develop relationships with top academic leaders who are investigating structural heart interventions + Collaborate with other functions interacting with structural heart interventions customers / physicians + Ability and willingness to travel up to 35% of the time **Program Oversight and Team Development** + Align strategy, budget and resource allocation in close partnership with the cross-functional partners. + Recruit, mentor, and support the professional growth of the Structural Heart Interventions Medical Affairs team + Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition + Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures **Qualifications** **Education** + A degree in medicine (MD, DO, etc.) with training in Interventional Cardiology is required. **Experience and Skills:** + Minimum 10 years relevant experience in related studies such as Structural Heart Interventions is required. + Relevant business experience in product development for Structural Heart Interventions. is highly desired. + Cardiovascular industry and structural heart interventions knowledge strongly preferred with proven ability to learn complex technology/clinical applications is required. + Significant experience with clinical research is required. + Strong leadership skills and demonstrated ability to build successful relationships with internal and external partners globally is required. + Previous people management experience is required. + Demonstrated capability, expertise and success in building teams to meet the needs of a global set of businesses is preferred. + Strong communication and negotiation skills to successfully influence and implement policy with key customers and partners is essential. + Must be able to collaborate well with multiple partners and work effectively in a matrix environment. + Previous industry experience leading Medical/Clinical teams in a regulated, commercial biomedical or medical device business is strongly preferred. + Experience in product risk evaluation and mitigation is preferred. + Demonstrated success in medical data generation, interpretation and publications is highly preferred. + A willingness and ability to travel approximately 35% domestic and international is required. The anticipated base pay range for this position is 160,000 - 276,000. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: + Vacation -120 hours per calendar year + Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year + Holiday pay, including Floating Holidays -13 days per calendar year + Work, Personal and Family Time - up to 40 hours per calendar year + Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child + Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year + Caregiver Leave - 80 hours in a 52-week rolling period10 days + Volunteer Leave - 32 hours per calendar year + Military Spouse Time-Off - 80 hours per calendar year At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through innovative programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love! At Johnson & Johnson, we offer a variety of outstanding health and financial benefits, including competitive compensation, 401k, pension, medical, dental, and vision insurance, exercise reimbursement, flexible time off, paid volunteer and parental leave, and more! For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ******************* . 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. _Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation,_ **_external applicants please contact us via_** **_*******************/contact-us/careers_** **_. internal employees contact AskGS to be directed to your accommodation resource._** **_\#PULSE #EP_** **Required Skills:** **Preferred Skills:** **The anticipated base pay range for this position is :** $164,000.00 - $282,900.00 Additional Description for Pay Transparency:
    $164k-282.9k yearly 60d+ ago
  • Associate Director, Field Medical Affairs Rare Disease-Bone & Genetic Medicine (Western US)

    Regeneron Pharmaceuticals 4.9company rating

    Los Angeles, CA jobs

    As an Associate Director, Field Medical Affairs, you will play a pivotal role as a field-based, professional within our General Medicine Rare Disease group. You will deliver both strategic and operational support by establishing, developing, and maintaining high-level scientific exchange with the medical and research community aligned with our strategic objectives. This role focuses primarily on rare bone disease will also support our genetic medicine portfolio. Additionally, we ensure the timely, ethical, and customer-focused and accurate exchange and distribution of clinical and scientific information relevant to both our in-line and pipeline products. **Territory:** Western US (residency in California, Texas (Dallas or Houston) or other major airline hub city is preferred) **A typical day may include the following:** **Scientific Expertise & Exchange** - Demonstrate deep expertise about assigned compounds and the therapeutic areas and disease states while facilitating scientific exchange, information and provide insights. - Maintain current knowledge of emerging therapies, clinical data and the competitive landscape - Effectively communicate complex scientific and clinical information to HCPs and KOLs. **Stakeholders Engagement & Relationship Building** - Build, nurture, sustain and improve relationships with scientific and medical customers and organizations ensuring understanding of evolving healthcare trends. - Identify and engage KOLs and decision makers in rare bone and genetic disease community - Provide medical education and support at conferences symposia and advisory boards. **Strategic Collaboration & Cross-functional Partnerships** - Collaborate with internal cross-functional teams (HQ-Medical Affairs & Clinical Development) to ensure coordinated and aligned activities. - Share actionable field insights that inform strategic planning and product development. **Healthcare Trends and Market Access** - Demonstrates proficiency in value/cost of care, hospitalizations, risk of progression, drug pricing pressures, reimbursement/payer education, and market access support. - Brings impactful information & insights improving the value and appropriate use of our products. Builds and cultivates working relationships across field partners ensuring a coordinated approach. - Sustains expertise in compound data, disease state management, emerging therapies, and the competitive landscape Compliance and Governance - Responds to health care provider inquiries with integrity, compliance, and adherence to legal, regulatory, and Regeneron guidelines, policies & procedures. F **ield Leadership & Mentorship** - Contribute to specials projects, initiatives and field medical training programs **This may be for you if you:** - Want an opportunity to impact patient lives through scientific leadership in rare diseases. - Proven ability to communicate and disseminate scientific and clinical data effectively. - Are comfortable covering a large territory - Are passionate about helping patients To be considered an Advanced Clinical/Science Degree (MD, PharmD, PhD) is required as well as a minimum of 5 years of relevant experience (clinical, managed care, or pharmaceutical industry) including 2 years of experience in a Field Medical Affairs position (Medical Science Liaison or equivalent). Demonstrated expertise in rare bone diseases; experience in rare/genetic diseases strongly preferred. Residency within the designated territory is required. Willingness to travel (up to 50%) within the territory and attend national/international conferences as needed. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. **Salary Range (annually)** $173,500.00 - $283,100.00
    $173.5k-283.1k yearly 60d+ ago

Learn more about Genentech jobs