BeOne Medicines

Director

BeOne Senior Director, Clinical Development, Breast Cancer role to support clinical and medical assets by execution of clinical development programs; work across organization and external partners
Involved in clinical program strategy and ensure activities executed within scope, budget and timelines
Establish and grow Clinical Research functions for global capabilities and execution
Collaborate with clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research
Generate, author, update, and review key documents: protocols, informed consents, IBs, CSRs, abstracts, posters, manuscripts, IND/NDA clinical sections, DSURs, HA Briefing Documents, Orphan Drug applications
Partner with clinical operations for implementation and execution of clinical studies
Provide scientific expertise for investigator and vendor selection; train colleagues, CROs, and site staff
Provide medical support during trials; respond to sites, IRBs/IECs, Health Authorities, and CROs
Review, query, analyze clinical trial data; interpret and present data internally and externally
Represent clinical study/program on internal teams; build opinion leader networks; organize advisory boards and investigator meetings
Contribute to therapeutic area research and competitor analysis; identify process improvements and resource needs
Develop, track, execute and report on goals; support budget planning and compliant business practices

Senior Director, Clinical Development – Breast Cancer

Manager

• Writes, submits, and manages clinical trial registrations, tabular results, lay summaries, and maintenance updates in accordance with BeOne policy and international regulations
• Maintains and updates data disclosure tracking tools and dashboards to comply with registration, results posting, and data sharing requirements
• Manages redaction and anonymization of personal data and confidential information and prepares anonymization reports and justifications
• Facilitates cross-functional team review and approval of transparency submissions on time and within compliance requirements
• Leads and manages special projects involving transparency and provides updates on project status
• Supports Data Sharing Coordination activities and develops/implements processes, standards, and training materials for Data Disclosure & Transparency activities
• Ensures adherence to applicable policies, procedures, and quality standards; may include supervisory responsibilities and vendor management

Manager, Data Disclosure and Transparency

Digital Marketing

• Develop and execute a comprehensive digital marketing strategy that aligns to our Market Access priorities.
• Collaborate with our Global Omnichannel team to identify and leverage digital platforms and assets to enhance our Market Access digital footprint.
• Lead the content development and manage the maintenance of our external Market Access customer website: BeOneEngage.com.
• Represent all digital materials submitted to our Promotional Review Committee (PRC) to ensure all final resources meet our business objectives while ensuring compliance.
• Lead operational tactics such as master service agreements negotiations, SOW submission and the corresponding budget management for our digital efforts.
• Work closely with our Evidence team and our MVO team to ensure we appropriately incorporate their outcomes studies into our nonpersonal communication campaigns.
• Holds understanding of the complex healthcare provider dynamics and evolving market access landscape and challenges.

Director, Digital Marketing – Market Access, Strategic Marketing

Medical Director

• Support BeOne Clinical and Medical assets within the Hematology franchise by developing early and late phase clinical development strategies
• Work in partnership across the organization, with external vendors, academicians and collaboration partners
• Report to the Vice President of Clinical Development Hematology
• Participate in clinical program strategy and ensure activities executed within scope, budget, and timelines
• Establish and grow Clinical Research functions to ensure global capabilities and execution
• Collaborate with clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research
• Author, update, and review key documents including protocols, informed consent, investigator brochures, clinical study reports, manuscripts, INDs, NDAs, and health authority documents
• Partner with clinical operations for successful implementation and execution of clinical studies
• Provide scientific expertise for investigator and vendor selection
• Provide scientific and medical support during clinical trials and respond to queries from sites, IRBs, Health Authorities, and CROs
• Review, query, and analyze clinical trial data; interpret and present data internally and externally
• Represent clinical study or development program on teams or subteams; create study-related slide decks
• Build and maintain opinion leader/investigator networks; organize advisory boards and investigator meetings
• Conduct therapeutic area research and competitor analysis; identify process improvement and resource needs
• Develop, track, execute and report on goals and objectives; support budget planning and management
• Ensure compliant business practices and foster global competencies

Executive Medical Director

• Lead the development and negotiation of provider contracts to optimize market access for solid tumor products such as Tevimbra, ensuring terms are favorable and compliant with organizational standards and regulatory requirements.
• Build and maintain strong relationships with targeted providers, ensuring effective communication and collaboration to support contract execution and management.
• Collaborate with cross-functional teams to identify, assess, and implement contracting strategies that are aligned with overall business plans and objectives.
• Conduct research and analysis on provider landscape and dynamics such as provider's net cost recovery (NCR), reimbursement dynamics (e.g., buy-and-bill), and average sales price (ASP) implications to inform contracting decisions and identify opportunities for optimization.
• Assist in evaluating new pricing & contracting approaches to inform and shape pipeline asset price potential and implications.
• Work closely with Finance, Legal and Compliance to ensure all provider contracts comply with relevant regulatory requirements and standards, including state and federal healthcare regulations.
• Monitor and report on contract performance, using data-driven insights to make adjustments and improve outcomes.
• Continuously seek opportunities for innovation and improvement in contracting strategies and processes.
• Engage with key internal and external stakeholders to understand their needs and ensure contracting strategies align with organizational goals.

Senior Manager, Contracting Strategy

Operations

• Key contact for GPMS operations and governance across BeOne publications
• Lead the maintenance of the GPMS; facilitate all internal efforts for vendor enhancements, customization, and maintenance of the publication database
• Lead the development of new GPMS training materials as per updates to organization, SOP, and database, and all necessary updates to existing documents
• Provide GPMS onboarding and training for internal team members, cross-functional partners, and vendor partners to ensure compliance with BeOne policies
• Conduct internal publication audits to ensure publications are being developed in an ethical and SOP-compliant manner
• Ensure publications/communications are archived appropriately to document compliance with SOPs and Good Publication Practices
• Perform regular metric reports for senior leadership and cross-functional teams
• Support development of regular communications for distribution to cross-functional teams

Senior Manager, Publications Systems & Operations

Strategy

• Responsible for supporting the development and execution of strategies across market access field segments, analyzing market dynamics, gathering customer and competitive insights, and driving data-driven strategies to enhance product access and profitability.
• Collaborate with Market Access leadership, MA field teams, and cross-functional stakeholders to define and implement short-term and long-term strategies; leverage third-party data to analyze access dynamics and inform pricing decisions.
• Present findings to leadership with actionable insights on contracts, product positioning, analytics-driven portfolio prioritization, pricing strategies, and customer partnerships.
• Monitor access environment and competitive landscape; coordinate with business analytics teams to assess trends and financial implications; ensure alignment between strategy and operations.
• Lead or participate in projects analyzing market disrupters and trends (biosimilars, regulatory changes) and translate insights into strategic opportunities.
• Travel required 15-25% domestic (per job listing) though the role is remote within the US.

Associate Director, Market Access, Business Strategy

• Facilitate generation, author, update, and/or review key documents, including protocols, synopses, amendments, informed consent documents, Investigator Brochures, clinical study reports, and regulatory submissions
• Provide scientific and medical support during conduct of a clinical trial; respond to questions from sites, IRBs/IECs, Health Authorities, and CROs
• Build and maintain investigator networks; organize and present at key opinion leader advisory boards and investigator meetings
• Develop clinical program strategy and ensure activities are within scope, budget, and timelines
• Build relationships with internal experts; train BeOne colleagues, CRO staff, and study site staff
• Manage budgets, track goals, and ensure compliant business practices
• Contribute to therapeutic area/indication research and competitor analysis

Medical Director, Hematology

• Senior Director, IIT & Expanded Access Programs in Global Medical Affairs; remote-based position with direct reports\n• Responsible for strategic management of IITs, Expanded Access Programs, and Phase IV BeOne-Sponsored studies, including implementation in multi-institutions and research settings in accordance with FDA regulations and Good Clinical Practice guidelines, tracking and budgeting\n• Lead IIT, EAP and Phase IV BeOne-sponsor study programs within Global Medical Affairs; interface with internal/external stakeholders; oversee review processes and budgeting\n• Functions as a leader and mentor for external coordinators, physicians, and other members of the Medical Operations team; collaborate with cross-functional colleagues in Regulatory, Quality, and Clinical Supply Chain\n• Manage the IIT trial management system and tracking of IITs, EAPs, Phase IV studies and post-hoc analyses; manage Trial Management Software vendor; implement changes based on business needs\n• Liaise with Attorneys for contract negotiations; ensure ethical and government standards (GCP) and SOPs; ensure accurate payments and reporting\n• Provide operational leadership to Medical Directors and Field Medical staff on IIT study proposal submission and activities; coordinate with key opinion leaders to identify issues or barriers to research request execution\n• Maintain monthly study status reports and metrics; collaborate with Accounting to reconcile payments; monitor budgets across projects\n• Lead cross-functional meetings; support/lead development of department policies; drive improvements to IIT program and processes\n• Ensure compliance with data collection and tracking milestones; support post-hoc analyses and publications as needed

Senior Director, Investigator-Initiated Trials & Expanded Access Programs, Global Medical Affairs

Auditor

• Senior Auditor role overseeing and conducting GCP audits to ensure compliance with GCP regulations and industry standards, in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices.\n• The position requires extensive knowledge of ICH GCP and applicable global & local regulations and guidance for clinical development.\n• Responsible for audit planning, execution (on-site or remote audits), reporting, CAPA, and coordination with stakeholders.\n• Supports GCP, GVP & GLP authority inspections (FDA, EMA, PMDA, TGA, CFDI, etc.) and contributes to preparation and hosting.\n• Travel up to 35% internationally; remote work options.\n• BeOne is a global oncology company focusing on developing affordable cancer treatments; over 11,000 employees.\n• Salary range provided: $130,600 - $175,600 per year.