Lifelancer

Chief Marketing Officer

• Lead the annual brand planning process for Cequa across both ECP and patient and ensure that the strategies are synergistic to drive growth and achieve goals
• Develop and execute all promotional materials for Cequa, including but not limited to: Core visual aid, website, flash cards, emails, banner ads, journal ads and disease education brochures
• Identify opportunities to evolve brand messaging based on new data, key market research insights and competitive learnings
• Develop and execute the Peer to Peer/Speaker Program Plan including development of core speaker deck, planning and execution of all logistics for speaker training events, management of contracts
• Lead the development of all brand content and promotional materials for congress meetings
• Provide input into the planning and development of content for Advisory Board Meetings as well as developing relationships with KOLs to seek input as needed
• Identify actionable insights from market research, advisory board meetings and competitive intelligence to inform brand messaging, communications and strategy. Continuously monitor results and adjust plans as needed to achieve goals
• Provide oversight and management of agency partners and implementation of all required documents – Creative Brief, MSA, SOW, POs
• Collaborate extensively with Sales, Medical, Commercial Training, Market Access, MI&A, Commercial Operations, Sales Operations, Finance and other cross-functional partners to ensure we are achieving key business goals (revenue, market share, and budget targets)
• Lead strategy, development and implementation of patient access platforms (PhilRx), this includes development of business rules, processes, internal and external communications
• Lead consumer and ECP and consumer digital marketing and social media plans including agency management
• Develop and execute ECP and Consumer media plans on time and budget
• Manage content and development of ECP and consumer websites including OCE platform
• Lead Field Input Team and act as liaison between brand and sales force representatives
• Manage Public Relations programs and events to amplify brand messaging
• Manage Tele-Health initiatives to expand awareness and choice for Cequa
• Develop and manage virtual representative team to address key targets
• Identify and develop relationships and programs with optometric organizations looking to expand into dry eye treatment
• Mentor and support junior team members helping in their education and development
• Manage assigned budget to ensure maximum ROI for investments and assure that budgets are not exceeded
• Understand landscape for Ophthalmic Dry Eye market and lead competitive intelligence of new and emerging products

Associate Director, Marketing – Ophthalmics

Manager

• Serve as SME for Active Directory, Microsoft Exchange, IDAM, SSO, and MFA implementations
• Manage multi-cloud and on-prem email systems including Exchange 2010/2013/2016/2019, Office 365, IBM, IceWarp
• Integrate email and AD systems with web-hosted apps, PTR entries, DNS, and email security protocols (SPF, DKIM, DMARC)
• Administer and integrate email solutions with critical apps like SAP SuccessFactors, HRMS, and enterprise platforms
• Lead email migration, consolidation, and security enhancement projects
• Configure and manage email archival using EMC SourceOne and related storage solutions
• Design, implement, and maintain multi-forest/domain Active Directory systems across Windows 2003–2019 environments
• Expert in Group Policy, DNS, AD replication, OU design, schema, and backup/restore strategies
• Act as mentor for junior engineers
• Collaborate with internal teams, vendors, OEMs
• Participate in project planning, execution, and documentation aligned with PMO framework
• Oversee project budgets, cost estimates, and financial planning for IT initiatives
• Track and report progress against project timelines, deliverables, and budgets

Senior Manager – Email Domain, Identity & Virtualization SME

Learning and Development

• Develop and execute a comprehensive learning strategy aligned with Cutaneous Oncology business objectives and brand priorities
• Lead end-to-end training strategy for pre-launch, launch, and post-launch phases
• Translate strategic imperatives into structured training plans that drive field readiness and performance
• Lead training delivery for national meetings, POAs, and key commercial initiatives
• Ensure consistency and scalability of training programs through standardized frameworks and best practices
• Design, develop, and maintain comprehensive curriculum maps across onboarding, launch readiness, and ongoing development
• Develop blended learning solutions including instructor-led, virtual, and digital learning formats
• Create and maintain training materials across disease state, product knowledge, market access, and selling skills
• Ensure all training materials are aligned with Medical, Legal, and Regulatory (MLR) requirements
• Lead all training components associated with product launch, ensuring field teams are fully prepared for execution
• Develop and implement certification programs, assessments, and readiness benchmarks
• Support training for complex disease states and oncology therapies, including mechanism of action, clinical data, and competitive positioning
• Partner with field leadership to embed coaching tools and reinforce training application in the field
• Serve as primary training partner to Marketing, Sales Leadership, Market Access, Medical Affairs, Compliance, and Sales Operations
• Lead cross-functional alignment to ensure training reflects brand strategy and customer engagement objectives
• Partner closely with Sales Operations to ensure alignment on tools, platforms, and reporting, and provide training support to enable effective field utilization
• Collaborate with internal stakeholders to ensure integration of reimbursement, payer, and access dynamics into training
• Represent Biologics training in enterprise learning initiatives and cross-functional forums
• Lead multiple training initiatives simultaneously, ensuring delivery within scope, timeline, and budget
• Manage external vendors and training partners to deliver high-quality, compliant learning solutions
• Develop and maintain training plans that outline objectives, strategies, and execution milestones
• Establish and monitor key performance indicators to assess training effectiveness and identify opportunities for improvement
• Maintain deep understanding of cutaneous oncology therapies and specialty markets, including immunology and dermatology
• Incorporate payer, reimbursement, and specialty pharmacy dynamics into training programs
• Ensure training reflects evolving clinical data, treatment paradigms, and competitive landscape
• Support field teams in navigating complex customer environments
• Utilize LMS, CRM platforms (e.g., Veeva), and digital tools to support training delivery and tracking
• Leverage data and analytics to measure training effectiveness and inform continuous improvement
• Stay abreast of emerging technologies, including AI-driven learning and field enablement tools, and incorporate them into training strategies where appropriate
• Incorporate innovative learning approaches including digital reinforcement and microlearning
• Partner with Sales Operations to support training on systems, tools, and platforms to ensure effective field adoption and utilization
• Demonstrate ability to influence without direct authority
• Provide subject matter expertise in instructional design and facilitation
• Foster a culture of accountability and continuous improvement

Senior Manager, Training, Oncology

Risk

• Support Amgen sponsored clinical trials globally
• Ensure appropriate governance and oversight of equipment and ancillary suppliers
• Collaborate with senior management, and partner with internal stakeholders and suppliers for process improvement
• Focus on Equipment and Ancillary suppliers with some overlap into customs and logistics
• Ensure quality oversight of suppliers by working with suppliers and internal customers to resolve issues related to supplier performance
• Facilitate and implement supplier governance meetings, monitoring key performance indicators, risk management and mitigation

R&D Supplier Governance Manager

Research Analyst

• Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects
• Conduct study initiation visits (SIVs)
• Ensure compliance with obtaining informed consent
• Reporting potential safety-related events

Senior Clinical Research Associate – Rare Disease

Business Development Rep

• Makes sales calls to prospective new clients to initiate new business relationships.
• Utilizes strategies and implements tactics to secure prospective sponsors to contract with Worldwide Clinical Trials.
• Coordinates the efforts for response to Requests for Proposals/Information.
• Achieve individual revenue and sales objectives through proactive communication and sales for the Worldwide Clinical Trials late phase services to assigned clients.
• Identify new contact leads for potential Phase II-IV Worldwide business.
• Develop and implement individual, territory and key account strategies that are specifically geared to the growth and retention of the client base.
• Coordinates and attends trade shows including making exhibition arrangements, organizing meetings, and hospitality suite arrangements.
• Ensures that trade show activities run smoothly and are within budget.
• Professionally conduct teleconferences, client meetings, general capabilities meetings, and bid defense meetings to all key accounts in pursuit of new business opportunities.
• Actively engage senior management in all major business presentations, and discussions regarding a strategic account and/or top opportunity.

Senior Director, Business Development – French Speaking

Project Manager

• Overall coordination and management of clinical trials from start-up through closeout activities
• Direct technical, financial, and operational aspects of the projects
• Work with major functional area leads to identify and evaluate fundamental issues on the project
• Ensure that all project deliverables meet the customer’s time/quality/cost expectations

Senior Project Manager – Oncology

Compliance

• Assist with the coordination of translation of regulatory correspondence and submission documents such as protocols, synopsis, ICF and labels
• Pack and dispatch regulatory submissions, site contracts, and site documents, follow up for delivery confirmation, obtain and file acknowledgement receipts and update relevant tracking tools
• Perform administrative QC of regulatory submissions, site documents and site contracts to ensure correct completeness and formatting
• Liaise with Finance requesting fee payment to Regulatory Authorities. Closely monitor the assigned Therapeutic mailbox and triage requests to the correct team members for prompt action

Assistant Regulatory Affairs – LATAM

• Liaise with SAR colleagues to drive plan, organize, compile, progress, track, and submit regulatory submissions on a timely basis and with a consistently high level of quality.
• May act as a contact point for translation review of submission documents such as applications, synopses, ICFs, labels, etc.
• Maintain country-specific patient information sheet and consent form customization text.
• Maintain country-specific drug labeling information and Country Intelligence Pages.
• Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country-specific requirements.

Regulatory & Site Activation Specialist

Operations

• Fulfil the "TMF Approver" role as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices.
• Process, review, and resolve rejected Trial Master File (TMF) documents, for multiple studies both in an electronic and hard copy format.
• Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents.
• Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
• Escalate any TMF Quality issues in a timely manner to RMC Lead.
• Provide administrative support for the RMC Lead including but not limited to filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
• Perform additional tasks as assigned by their Line Manager.

Associate I – TMF Operations

• Collaborate with Business Development, Therapeutic Leaders, Operations, Finance and Legal departments to draft and finalize contracts/change orders and contract termination documents with sponsors.
• Lead and participate in conference calls to negotiate terms of an agreement, including the study budget, with the sponsor.
• Ensure the scope of work is defined correctly and reflected in the study budget.
• Ensure any changes are integrated into the main study contract efficiently and accurately.
• Revise final proposal budget to reflect agreed upon specifications to include minor changes to the budget including updates to sponsor bid grids, if used, to reflect the revised budget.
• Develop and/or modify service description text in addition to original proposal text, which collectively becomes the core contract/exhibit.

Contract Manager

• Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects
• Typically involved in all stages of the clinical study, including identifying potential sites, conducting study initiation visits, and managing site activities
• Ensure compliance with obtaining informed consent and adhering to regulatory requirements

Senior Clinical Research Associate – Oncology

Solutions Engineer

• Lead end-to-end delivery of patient and site engagement activities across multiple clinical studies
• Coordinate and manage Worldwide vendors globally that provide strategic and operational support for specifically awarded projects
• Develop and manage detailed project plans, timelines, budgets, and resource allocations
• Monitor project performance, proactively identifying risks and implementing mitigation strategies
• Ensure projects are delivered on time, within scope, and aligned with sponsor and regulatory requirements

• Lead a single large product, and/or more complex studies and/or projects
• Ensure that all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct
• Influence and contribute to the development strategy, and defend statistical approaches internally and externally
• Implement, oversee and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis
• Plan and execute statistical contributions to protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), and other communications in close partnership with CROs in a full-service CRO model
• Provide statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents
• Oversee statistical work performed by CROs in a full-service CRO model
• Perform statistical analysis of multiple studies/projects and subsequent exploratory analyses, and make sound conclusions and recommendations
• Represent the Biostatistics function and participate in multidisciplinary project team meetings; collaborate closely with other functional team members; incorporate knowledge of cross-functional areas to inform and provide sound statistical guidance to teams (e.g. provide support and input in case report form design, and data collection)
• Proactively anticipate and communicate resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally
• Be familiar with statistical policy and strategy at Amgen; having working knowledge of theoretical and applied statistics and of regulatory guidelines and industry practice on biosimilar development
• Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances by publishing applied research in scientific journals and books and presenting statistical methodology at internal or external scientific meetings
• Participate in the review of CRO Policies, SOPs and other controlled document development, and in the development and review of Amgen-CRO’s process maps; contribute to process improvement and operational efficiency
• Adhere to all Amgen Policies, Standard operation procedures (SOPs) and other standards which are applicable to biosimilar development