Sumitomo Pharma America, Inc.

Outside Sales

• Achieving and exceeding sales objectives and growing market share
• Manage the assigned territory
• Establish deep and meaningful business relationships based on clinical and market dynamic expertise
• Increase market share by closing new business in new and existing accounts
• Support sales results with an exceptional level of clinical expertise and understanding of the evolving healthcare landscape
• Collaborate and provide candid communication with team members
• Assess and analyze product/competitor trends and market dynamics
• Travel throughout the territory, including overnight stays

Territory Sales Manager, Specialty

Clinical Operations

• Ensure monitoring across all studies is conducted in alignment with regulatory requirements
• Define and implement risk-based monitoring strategies
• Maintain expert proficiency in systems and technology for central monitoring analytics
• Contribute to design of novel systems in alignment with department and company data strategy
• Lead or contribute to cross-functional initiatives and process improvement efforts
• Assist with development and maintenance of inspection-readiness processes and materials
• Lead and provide oversight of the Clinical Records Management team
• Develop and/or review budgets for clinical operations and vendor budgets
• Manage direct reports, providing guidance, mentorship, and performance feedback

Senior Director, Clinical Operations

Sales

• Lead and directs a team of sales representatives, ensuring that they are well-trained on product knowledge, sales skills, market conditions, strategy and tactics, corporate policies and procedures, and business planning models
• Effectively assures the continued success of Orgovyx and maximize the achievement of regional sales objectives through execution of Brand Plan of Action strategies and tactics
• Ensure sales representatives have direct accountability for their given geography and clearly understand performance expectations
• Provide consistent, timely and accurate performance feedback based on observations of key customer interactions as part of an overall performance management process through timely assessment of performance using quantifiable outcomes
• Establishes consistency in leadership/management principles and practices across the region
• Develops strategies and tools to support sales representatives with business challenges
• Plans, forecasts, and oversees regional operating budgets, while actively monitoring expenses
• Monitors and assesses competitive sales activity in the market
• Shares information and makes recommendations to leadership
• Partners with Senior Sales Directors, Marketing, Training and Development, and the Commercial Operations teams to develop, implement, and manage the sales strategy and execution
• Stays well-versed and owns a strong understanding of payer mix, reimbursement environment, and distribution to lead a targeted strategy in assigned region
• Ensures all department personnel are fully informed of, and in compliance with Sumitomo Pharma America commercial compliance policy, all applicable federal and state laws and guidance relating to product promotion and information dissemination including, but not limited to, the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration’s implementing regulations, the Federal Anti-Kickback Statute, the False Claims Act, PhRMA, Corporate Code of Business Conduct and the Office of the Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers
• As a field-based position, this sales director role will require 40%-60% travel throughout a large geographic region, with occasional travel to corporate headquarters

Regional Sales Director – Prostate Cancer

Account Manager

• Deliver results by strategically educating key LTC stakeholders
• Collaborate with the sales team on educating LTC Healthcare Providers on SMPA product clinical attributes
• Ensure customer satisfaction by understanding their needs and promoting products or services
• Manage account strategies effectively and analyze competitive landscape
• Build business relationships with senior executives at key accounts
• Monitor GPO purchases and expense budgets

Regional Account Manager – LTC

Compliance

• manage regional (United States, European and/or ROW) regulatory activities as part of a Global Regulatory Team (GRT)
• leads regulatory activities for assigned project(s) in line with the global registration strategy of the product
• develops regulatory strategy and provides regulatory input as appropriate
• ensures compliance with global regulatory requirements and coordination of regulatory compliance activities at a global level
• provides updates to the Global Regulatory Team, project teams, and governance boards as needed
• maintains professional working relationships with colleagues, fostering collaboration, and idea sharing
• reviews nonclinical, clinical and CMC documentation and contributes to content as needed

Associate Director, Regulatory Affairs – Oncology

Marketing

• Lead the development and execution of the HCP marketing strategy for Orgovyx, aligned to the overall brand vision, lifecycle stage, and competitive landscape.
• Own the HCP messaging platform and ensure alignment across campaigns, peer-to-peer, and field tools.
• Translate clinical data into compelling, compliant, and differentiated messaging that resonates with Urologists, Oncologists, Radiation Oncologists, and APPs.
• Develop branded promotional materials and resources that support field engagement and peer-to-peer education.
• Collaborate cross-functionally with Sales, Sales Training, Medical Affairs, Market Access, Omnichannel, Patient Marketing, Legal, and Regulatory to ensure unified execution and strategic cohesion.
• Lead co-promotional coordination with alliance partner Pfizer, ensuring efficient development and timely deployment of materials.
• Apply market research, field insights, and performance data to refine strategy and optimize impact across HCP touchpoints.
• Manage agency partners and internal processes to deliver materials with speed, quality, and attention to detail.
• Ensure all content passes successfully through the Promotional Review Committee (PRC) process and adheres to compliance standards.

Director, HCP Marketing

Pricing Analyst

• Lead the strategy and execution of data-driven insights to support commercial decision-making on pipeline products.
• Act as the primary advisor to all Commercial Analytics & Field strategy functions as it relates to new approaches to analytics and market research techniques.
• Responsible for pre-launch commercial analytics for products in development.
• Assess commercial marketplace for pipeline products through primary and secondary research.
• Partner closely with Medical, Business Development, Finance and all areas of commercial in the establishment of analytics plans and the delivery of unbiased, insightful data-driven analyses in support of all pre-commercial assets.
• Establish competitive landscape and competitive intelligence for pre-commercial assets.
• Partner cross-functionally with the market research team to connect primary market research and secondary data analytics to tell a compelling and persuasive story and deliver clear and actionable recommendations to leadership.
• Drive innovation in analytics and business execution to positively impact brand performance and efficiency.
• Develop and implement an analytics and market research launch playbook.

Executive Director, Commercial Analytics – New Products/Innovation

• Lead the strategy and execution of data-driven insights to support commercial decision-making on pipeline products
• Act as the primary advisor to all Commercial Analytics & Field strategy functions on new approaches to analytics
• Responsible for pre-launch commercial analytics for products in development
• Responsible for assessing commercial marketplace for pipeline products through research
• Partner closely with Medical, Business Development, Finance and all areas of commercial
• Establish competitive landscape and competitive intelligence for pre-commercial assets
• Collaborate with Commercial Analytics on standardizing analytics services and approaches
• Drive innovation in analytics and business execution to impact brand performance

Executive Director, Commercial Analytics – New Products, Innovation

Director

• Develop and execute a comprehensive Oncology KOL engagement plan focused on prostate cancer management with ORGOVYX
• Partner with Brand Marketing Team to support cross-team initiatives (e.g., budgeting and business planning)
• Collaborate with the Thought Leader Liaison – Urology counterpart, along with field teams to ensure coordinated engagement
• Expand ORGOVYX’s presence and network into oncology centers of excellence and leading academic institutions
• Build relationships with GU oncologists and radiation oncologists shaping the prostate cancer treatment paradigm
• Lead ORGOVYX presence and engagement at major oncology congresses and regional meetings
• Design and execute innovative engagement formats outside of congresses
• Capture and analyze oncology-specific insights using frameworks to guide brand strategy
• Oversee speaker contracting and execution of prostate cancer-focused KOL engagement

Director – Thought Leader Liaison, Oncology

Insurance

• Manage global cash operational activities & forecasting.
• Manage bank and broker relationships.
• Oversee and manage treasury operations including cash management, banking structure, and funding operations.
• Oversee cash forecasting short-term and long-term cash forecasting using both direct and indirect methodologies.
• Support funding needs and excess cash flow understanding.
• Develop (in conjunction with VP) and execute Treasury strategy to reduce working capital globally across group entities to reduce excess cash levels.
• Direct corporate insurance programs in alignment with business risk profile.
• Manage Banker & Broker relationships.
• Oversee & manage cash pooling across SMPA group entities and parent entity in Japan.
• Design, research, recommend, and implement treasury systems to support operations.
• Manage short and long-term debt arrangements.
• Support and utilize inter-company payments & arrangements to optimize cash flow between entities while maintaining compliance and Tax strategy.
• Develop and support two direct reports.

Director, Treasury and Corporate Insurance

Project Manager

• Represents and leads the study team to design, develop and deliver the clinical study to agree upon timelines.
• Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data.
• Serves as primary contact and resource for CRO and vendor personnel in overarching functions as well as team members in parent company.
• Provides oversight and management of CROs, consultants and vendors.
• Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with the agreed study plans through regular CRO and/or investigator site contact.
• Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines.
• Monitors the status of clinical data collection of assigned clinical trials.
• Prepares potential investigator site lists and assists with their evaluation for inclusion in the study.
• Prepares and reviews study-related documents when required.
• Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentations are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
• Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required.
• Participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops and CRO Training.
• Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members.
• Monitors budget for clinical study, and review budgets and contracts with CROs, vendors and investigator sites (as applicable) in collaboration with Finance and Legal team.
• Requests and critically evaluates proposals and change orders from CROs, vendors and investigator sites (as applicable).
• Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
• Ensures assigned studies adhere to all applicable regulations and requirements.
• Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates.
• Evaluate CRO and vendor performance and support the improvement initiatives.
• Participate in the preparation, review, updating and training of SOPs.
• Maintain knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
• May Mentor other team members.
• Perform other duties as requested by the senior management.

Senior Manager, Clinical Project Management

• We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Vice President, Regulatory Affairs, Biopharma R&D. This position leads the Regulatory Affairs for biopharma R&D, report to the Chief Development Officer for biopharma R&D. Responsible for providing leadership regulatory strategies for earliest possible approvals for the assets under Biopharma R&D. Focus of Biopharma R&D is Gemtesa, Myfembree, Rethymic and regenerative medicines and CNS assets.
• Regulatory Strategy Develop and Manage Regulatory Affairs Strategy: Develop and gain approval for regulatory strategy to meet the Company’s objectives. Oversee the execution of the most effective product registration pathways to bring products to market in a cost-effective and highly compliant manner Collaboratively ensure that regulatory strategies are aligned to the SMP group business strategy Collaborate with Head of RA at SMP appropriately Provide oversight on evaluation and analysis of trends pertaining to government regulatory activities on a global basis and anticipate impacts that changing regulations will have on the Company’s product portfolio. Serve as the resident senior expert on all regulatory matters with key external stakeholders, internal steering/review committees, business partners, and government entities on a global basis Recommend and facilitate decision making on all Regulatory matters in close partnership with the Chief Development Officer and other key stakeholders Establish key business metrics with market reference points to gauge RA productivity and efficiency Develop, present and manage RA budget and resource plan in close partnership with regional operating centers, the corporate planning and other appropriate functional groups Responsible for providing global guidance and monitoring of global regulatory line items in the clinical development projects budget process Serve as the senior point of contact for internal communication Ensure that development of launch materials/new claims with Marketing, Medical and Legal are guided by applicable regulatory requirements Establish strong education/awareness of regulatory requirements cross functionally through comprehensive education initiatives Oversees Regulatory operation and medical writhing team as appropriately Perform other duties as directed.
• Manage and Develop Talent Inspire and lead RA staff to ensure attainment of established goals and objectives Ensure global compliance with all relevant internal and external policies and regulations applicable to drug development and regulatory approval Promote a high performance –results oriented collaborative work culture Establish clear expectations, and monitor delivery of excellent performance Establish resource plan to ensure that RA strategy and operational plans are appropriately resourced to support the Company’s business imperatives Promote work environment that includes employee development, accountability, proactive feedback and high performance standards.
• Regulatory Best Practices Promote and integrate industry best practices that fit well with the Company’s operating culture Promote a highly interconnected RA operating culture Establish and oversee compliance to global SOPs and work practices governing all phases of the regulatory process Ensure that regulatory pathways are developed to deliver well planned registration roadmap with full understanding of the risks and opportunities Develop and manage the regulatory affairs budget with a focus on cost-effectiveness, efficiency and maintenance of quality Communications Accurate and timely reporting status regulatory projects; escalate unresolved issues to appropriate executive leadership Steward communications with regulatory agencies to ensure favorable registration outcome Build and Maintain Key Relationships Develop highly collaborative and responsive relationships with key stakeholders Represent R&D decision committees defined as company rules Business Development Support Business Development and New Product Planning and assessment activities specifically related to regulatory analysis and due diligence. Also support regulatory filings and joint committee membership with strategic partners.

VP, Regulatory Affairs – R&D, Biopharma

Procurement

• Drive value by partnering with stakeholders across departments to deliver source-to-contract activities for R&D services
• Negotiate and contract with supply base and ensure alignment with category strategies and business plans
• Deliver strategic sourcing, contract management, supplier market intelligence, financial productivity, supplier performance management, and risk mitigation
• Develop and execute Sourcing Category Plans; negotiate and redline service contracts and statements of work
• Lead end-to-end competitive sourcing activities (RFx), generate sourcing insights using spend analytics and benchmarking
• Maintain sourcing practices in accordance with corporate ethics, financial policy, and internal control requirements
• Pursue ongoing development of relevant skills and lead change management to improve productivity and efficiency

Manager, Strategic Sourcing, R&D

Customer Success Manager

• Define and execute the Veeva CRM roadmap aligned with commercial and medical strategies.
• Establish governance processes to ensure data quality, compliance (e.g. PDRP, GDPR, CCPA), and system integrity.
• Serve as the primary business owner of Veeva CRM, ensuring alignment with commercial goals.
• Lead the configuration design, deployment, and continuous improvement of Veeva CRM modules (e.g., Veeva CRM, CLM, Approved Email, Engage).
• Collaborate with Commercial IT and third-party vendors to manage system enhancements, integrations (e.g., MDM, data warehouses), and issue resolution.
• Ensure seamless integration with other commercial platforms (e.g., Veeva Vault, Salesforce Marketing Cloud, BI tools).
• Partner with Sales, Marketing, and Field Medical teams to translate business needs into CRM functionality.
• Support territory alignment, call planning, and multichannel engagement strategies.
• Monitor and improve field adoption through training, feedback loops, and change management.
• Support development and maintenance of dashboards and KPIs to track field activity, HCP engagement, and CRM utilization.
• Collaborate with Commercial Analytics to generate actionable insights from CRM data, as well as Commercial Reporting to identify metrics for integration in ongoing reporting.
• Drive continuous improvement through data-driven recommendations.
• Direct the Enterprise CRM team by providing guidance and mentorship, while ensuring ample opportunities for learning and that career goals are met
• Act with speed, agility, and accountability, while adapting to evolving business needs
• Cultivate meaningful internal and external partnerships, adding value and insights for the organization
• Key Core Competencies
• Strategic thinking and ability to align CRM capabilities with business goals.
• Keen ability to prioritize competing requests keeping the focus on business priority
• Strong project management and stakeholder engagement skills.
• Excellent communication and cross-functional collaboration.
• Analytical mindset with ability to derive insights from CRM data.
• Deep understanding of pharmaceutical sales models and compliance requirements
• Proven success leading and developing a team