Amgen

Director

• Develop communications strategies and plans that effectively and consistently communicate to targeted key audiences and stakeholders about the science and innovation going on in research.
• Once fully vetted and approved, flawlessly execute on those plans and deliver measurable results.
• Develop and support executive engagement plan for Research SVP and key VPs, including proactively preparing company spokespeople via media training / presentation skills.
• Partner with the media relations team to address incoming media requests related to research and proactively work to garner press coverage with trade press to elevate Amgen as very much part of the wave of transformation sweeping drug discovery.
• Partner with the product communications team and therapeutic leads on therapeutic area strategy and positioning.
• Manage and direct public relations agency partners to assure maximum impact and assistance in reaching desired communications goals and objectives.
• Work in partnership with Research leaders and HR on employee engagement / internal communications.
• Partner successfully with investor relations to ensure consistency of messages to external audiences including media and financial world.

Corporate Affairs Director – Research

Medical Director

• Establish the strategy, direction, and priorities of global safety activities
• Accountable for the overall safety profile and all product-related decisions and deliverables for assigned products
• Serve as the safety expert of the assigned product(s) and or setting the strategy, direction, and priorities of pharmacovigilance activities in the dynamic field of obesity and related conditions
• Manage Safety Directors, Associate Safety Directors, and/or Global Safety Professionals
• Accountable for providing strategic oversight, direction and authorship for all major regulatory safety submissions
• Lead the safety strategy and Benefit/Risk Management Process for assigned asset(s) across all indications in the portfolio
• Safety representative to cross functional meetings in providing strategic input for evidence generation, data review and regulatory documents and responses
• Lead and contribute to functional projects for process improvement as needed.

Senior Medical Director, Global Safety – Obesity and Related Conditions

Sales

• Be the liaison to our customers by providing clinical knowledge of our products to medical professionals
• Track the progress of marketing messages and programs
• Provide feedback to district teams on the marketing, allocating, monitoring, and leveraging of internal and external resources
• Manage district teams to maximize their performance and help achieve/exceed sales and budget targets
• Screen, interview, and hire candidates
• Ensure compliance with training
• Demonstrate the appropriate coaching and counseling to prepare individuals for future development
• Conduct annual and on-going performance reviews and competency assessments
• Communicate and coordinate with both district and cross-functional teams
• Share best practices with direct reports and peers
• Coordinate and/or participate in cluster teams
• Conduct district sales meetings to guide districts
• Develop local Opinion Leader relationships to achieve aligned objectives

District Sales Manager – Oncology

Compliance

• Execute U.S. regulatory strategy and deliverables for assigned programs and represent the region on global teams (e.g., GRT; may include GDT/CST/LWG as applicable).
• Plan and manage U.S. regulatory submissions (e.g., clinical trial and marketing applications) aligned with global filing plans and U.S. regulatory requirements.
• Implement product-related regulatory tactics and activity plans in accordance with U.S. legislation, regulations, and internal standards.
• Provide content guidance for key U.S. regulatory documents and meetings consistent with GRT strategy (e.g., briefing content, submission components).
• Support U.S. labeling development in collaboration with the Labeling Working Group (LWG), incorporating scientific data, guidance, and precedent; support U.S. labeling negotiation activities.
• Provide regulatory guidance on U.S. mechanisms and pathways to optimize development (e.g., expedited programs, orphan considerations, pediatric plans, compassionate use where applicable).
• Obtain and maintain clinical trial authorizations and marketing application approvals, including support for Responses to Questions (RTQs) and other agency feedback.
• Communicate regulatory strategy and expectations within the team (e.g., GRT, affiliates/stakeholders) and work with line management to assess likelihood of success, expectations, and risks.
• Ensure ongoing regulatory compliance for assigned products (e.g., IMR accuracy, PMCs/commitments, pediatric and other agency obligations); escalate issues proactively.
• Maintain and apply U.S. regulatory intelligence: monitor evolving legislation/guidance; research precedent and history; assess and communicate potential impact (including competitor labeling where relevant).
• Support Health Authority interactions by acting as an agency contact as appropriate, documenting outcomes, and contributing to risk/contingency planning consistent with global strategy.
• Partner with cross-functional teams to support alignment and execution, including U.S.-specific considerations for data use in product communications (as applicable).

Regulatory Manager – Obesity, Related Conditions

• The Director, Global Regulatory Lead (GRL) provides strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditions.
• The GRL is accountable for developing and executing global regulatory strategies, shaping cross-functional decision-making, and leading global interactions with Health Authorities and external partners.
• Develop and lead global regulatory strategy for obesity and metabolic disease programs with focus on Type II diabetes.
• Integrate clinical, nonclinical, CMC, and safety evidence into cohesive regulatory recommendations.
• Lead the creation of the Global Regulatory Strategic Plan (GRSP), including risk assessment and regulatory scenario planning.
• Advise on key clinical development elements relevant to obesity programs.
• Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams.
• Oversee execution of major global regulatory submissions, including clinical trial applications and marketing applications.
• Lead strategy development and preparation for key Health Authority interactions related to metabolic disorders.
• Build, mentor, and support high-performing global regulatory teams.

Global Regulatory Director Lead – Obesity & Related Conditions, Type II Diabetes

Content Marketing Manager

• Lead the end-to-end omnichannel engagement strategy, content ecosystem, and production operations across non-personal channels.
• responsible for delivering high-impact, data-driven, and scalable customer experiences that drive behavior change among healthcare providers (HCPs).
• report to the Brand Lead Executive Director.
• Lead the integrated omnichannel strategy across digital and non-personal channels in close partnership with audience leads and promotional teams.
• Orchestrate seamless customer journeys across web, CRM, paid media, social, and emerging channels.
• Champion Customer 360 strategies, enabling personalization and optimized engagement across the HCP experience.
• Build and lead a high-performing content production engine, delivering high-quality, compliant content at scale.
• Oversee modular content strategies, enabling reuse, speed, and personalization.
• Drive innovation in AI-enabled content production and automation pilots.
• Ensure alignment of content to channel strategy, audience needs, and brand priorities.
• Oversee strategy and execution across key channels.

Director, Omnichannel Marketing – Content Production, Cardiovascular

• Join Amgen’s Mission of Serving Patients.
• Provide local input to and execute regulatory strategies.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
• Manage the regulatory submission of urgent safety communications, DHPCs & DILs as required by Amgen SOPs or local regulatory requirements.
• Collaborate with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).

US Regulatory Lead

Chief Marketing Officer

• Lead the development and implementation of the long-term vision and strategic roadmap for CV IMPACT that will help to guide cross-functional priorities
• Design the execution of innovative initiatives and tactics in alignment with brand strategic imperatives
• Ensuring flawless execution of workstream programs, cross-stakeholder summits, communication campaigns, sponsorship pull-through, etc.
• Engage often with opinion leaders, patient and professional societies, institutional decision makers, and payers
• Lead coordinated pull-through of key programs and above brand campaigns across functions and channels
• Lead projects through the legal, regulatory, and medical review process
• Managing program budgets and performance metric tracking to ensure success

Marketing Director

Clinical Research

• Support set up and execution of late phase clinical trials with a focus on data quality
• Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity
• Provide input into & implementation of data management plan, CRF design, and data review oversight
• Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
• Assists Development Lead and Clinical Scientist Director in medical monitoring and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
• Anticipate and actively manage problems across a broad spectrum of cross-functional teams
• Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
• Support appropriate training, recruitment, and development requirements for matrix team resources

Clinical Scientist Associate Director – Late Development Obesity

Administrative Assistant

• Managing calendars and scheduling meetings (Outlook) including across multiple time zones
• Managing multiple governance calendars and scheduling meetings.
• Working with Directors and Executive Directors to finalize agendas and invitees.
• Managing calendars for 3 Executive Directors and 3 Directors as needed.
• Tracking software licenses for the IPA organization and managing PO’s as needed.
• Help coordinate annual Face to Face organization meetings
• Coordinate functional processes such as invoicing & purchase orders
• Coordinate local and international travel arrangements & preparing expense reports
• Maintaining department email distribution lists
• Timely Registration for conferences, congresses, seminars, and internal meetings
• Provide backup support to additional department admins

• Provide strategic oversight and direction for all major regulatory safety submissions and responses or strategic deliverables
• Leads the safety strategy and Benefit/Risk Management Process for assigned portfolio
• Chairs or participates in safety governance meetings per Standard Operating Procedures and Manuals
• Accountable for the Development and maintenance of core reference safety information
• Analyze safety data from clinical studies and contribute to core safety messages and conclusions
• Develop responses to safety-related inquiries from regulatory agencies and ethics committees
• Ensure staff are compliant with Amgen corporate and departmental training and SOP review
• Provide training, coaching, mentoring, and development of staff.

Global Safety Senior Director, PV – Obesity

Account Manager

• Representing Tavneos to physicians and healthcare professionals
• Establishing product demand and delivering comprehensive account management within a designated territory
• Educating medical professionals and external stakeholders on disease state awareness and product information
• Driving product utilization while identifying and addressing the unique needs of each account
• Building and maintaining strong relationships with healthcare providers
• Coordinating cross-functional field teams and executing aligned strategies to ensure access, education, and support for rare disease treatments
• Developing and executing a comprehensive territory business plan to achieve and exceed sales objectives
• Promoting Tavneos within approved labeling in compliance with corporate and industry guidelines
• Serving as a trusted partner and disease expert to healthcare professionals by delivering meaningful education on disease state and product information
• Navigating and engaging within diverse healthcare delivery settings
• Identifying and addressing patient access, reimbursement, and pull-through challenges
• Coordinating internal matrix teams to deliver integrated, account-specific solutions
• Leading or supporting the development of referral networks and site-of-care pathways
• Establishing productive relationships with local and regional KOLs
• Actively contributing field insights and market intelligence to inform strategy, resource deployment, and future planning
• Maximizing use of promotional resources and operating within assigned territory budget
• Representing the company at appropriate medical congresses and educational events
• Completing all training and administrative responsibilities in a timely and accurate manner while upholding all company policies and compliance standards.

Account Manager, Specialty

• Develop and execute regulatory strategy in close partnership with the Global Regulatory Lead (GRL), serving as the U.S. regulatory lead for global programs in obesity and related cardiometabolic conditions.
• Represent the U.S. on global teams, contribute to global regulatory and clinical development strategies, and support the acquisition and maintenance of commercial licenses.
• Ensure Amgen secures and maintains required U.S. licenses and authorizations to support clinical development and marketed products in compliance with regulatory requirements.
• Lead U.S. regulatory submissions (e.g., clinical trial and marketing applications) in alignment with global filing plans and regulatory requirements.
• Monitor and apply U.S. regulatory intelligence, including evolving legislation, guidance, and relevant competitor activity.

Senior Regulatory Affairs Manager – Obesity and Related Conditions

Manager

• Design and execute studies based on causal inference frameworks to support evidence generation such as identifying appropriate patient populations, assessing disease burden and resource utilization, obtaining product registrations and label-expansions, meeting post-marketing requirements/commitments, and product differentiation
• Identify opportunities to substitute for and/or complement interventional studies to reduce time and cost of drug development
• Influence cross-functional stakeholders as to the appropriate use and timing of non-interventional research to answer high-priority strategic business questions
• Leverage real-world data and CfOR analytic approaches to inform high-value business decisions for multiple stakeholders
• Contribute to the mission of CfOR, including progressing innovative epidemiological methods and analytical capabilities to support CfOR’s leadership role within Amgen and industry

Senior Manager, Observational Research – Pharmacovigilance, Epidemiology, Causal Inference, Obesity

• Support late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials.
• Provide hands-on oversight of protocol execution, medical data review, and clinical data quality to enable high-quality, decision-ready data.
• Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity.
• Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues.
• 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 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), delivery, clinical data review, and 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.