Executive Director, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operation

At Daiichi Sankyo, we are united by a single purpose: to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society," we are shaping a healthier, more hopeful future for patients, their families, and society.

About the role

Lead the Global Clinical Operations Team by providing strategic and tactical guidance and support for clinical staff with a high degree of quality in the execution of all Global Medical Affairs medical activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. Deliver Evidence Generation projects in preparation for launch activities in Oncology Business unit countries as well as in other Regions. Responsible for all primary data generation in GMA studies (i.e., Company Initiated Interventional Studies (CIS), Non-interventional Studies (NIS), Expanded Access Programs (EAP), Investigator Initiated Studies (IIS), and External Collaborative Study Research projects (ECSR)). Ensure successful execution, timelines, and clinical milestones. Accountable for overall Clinical Operation performance against key metrics and all budget-related management.

Responsibilities

• Clinical Operations Study/Program Management
  • Responsible for primary data evidence generation delivery of GMA programs: Company Initiated Studies (CIS), Non-Interventional Studies (NIS), and Expanded Access Programs (EAP) across countries in the Oncology Business Unit and other Regions.
  • Ensure preparation, execution, and reporting of all clinical trial activities, adhering to timelines, budgets, quality plans, and relevant ICH/GCP Guidelines.
  • Provide strategic input into the development of protocols to ensure designs are implementable to efficiently achieve the objectives.
  • Provide strategic input in the development of CRFs, ICFs, Monitoring Plans, final reports, and publications as applicable.
  • Develop, implement, and ensure adherence to timelines, program objectives, and monitoring plans.
  • Accountable for accuracy and timeliness of information in all databases and tracking systems.
  • Contribute to the development of clinical sections of regulatory documents such as Investigators’ Brochures and safety updates/notifications.
  • Ensure all key internal stakeholders are aligned on the approach and conduct of global studies/programs implemented in multi-regions (US, Europe, ASCA, Japan), including Regional Medical, Regional Operations, Safety, Regulatory, Quality, Legal/Compliance, Clinical Supply Operations, Global Program Teams, GMAT Leads, and GMA leadership.
  • Have a robust management plan in place before starting a study/program to ensure optimal control and monitoring, minimize risks, and ensure timely response to treating physicians.
• Investigator Initiated Studies (IIS) and External Collaborative Research Studies (ECSR)
  • Provide oversight of the overall IIS process related to third-party Investigator Initiated Studies and External Collaborative Research Studies (ECSR) as per the Standard Operating Procedure (SOP) (regional review, Global review, tracking of milestones as per contract).
  • Ensure the IIS process is revisited regularly to adhere to the SOP and identify and remediate/correct any gaps in a timely manner to ensure robust preparation and review by the Global IIS committee, as well as proper documentation of decisions and document repository.
  • Oversight of the IIS system for management of IIS review and approvals (IMPACT).
• Oversight of Study Teams (ST) for GMA Medical Programs
  • Develop an overarching project management plan.
  • Lead (or delegate to a team member) and manage the global multidisciplinary team to ensure all trial deliverables are met according to timelines, budget, quality standards, SOPs, and Business Guidance; chair ST meetings, report study progress and issues with their resolution plan; lead trial-level interactions with relevant functions including Drug Supply Management and local medical organizations.
  • Anticipate and efficiently mitigate risks.
  • Collaborate with cross-functional team members (e.g., pre-clinical, manufacturing, data management, safety surveillance, biostatistics, Regulatory Affairs, Quality Assurance, HEOR if applicable).
  • Lead the team to develop a functional center of excellence in clinical trial execution by identifying and implementing best-in-industry practices.
  • Accountable for overall management of the clinical trial team when applicable.
  • Ensure clinical operations teams' regulatory and Good Clinical Practice (GCP) compliance.
  • Comply with applicable regulations, GCP, and corporate policies and procedures.
• Vendor/CRO/Supplier Management
  • Develop clinical outsourcing specifications in collaboration with respective line functions to facilitate bid templates and selection of CROs; provide strong oversight of CROs.
  • Responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at an overall study level.
  • Identify and evaluate potential clinical partners which may include CROs, investigators, and other vendors necessary to execute the medical program.
  • Ensure selection of experienced CROs and internal resources for proper oversight and management.
• Managerial Responsibilities
  • Establish annual objectives for the Clinical Operation group according to GMA priorities and individual development needs.
  • Participate in the hiring, on-boarding, training, and mentoring of new staff.
  • Identify individual training needs to foster high levels of performance, support career development through quality development plans, and proactively manage performance issues.
  • Manage all budgets, contracts, agreements, and vendor payments related to clinical trial programs in an effective and transparent manner.
  • Manage and report on study budgets to include addressing variances, payments, and revisions, as applicable.
• Regional Support
  • Work with the Regional Teams to ensure concepts and protocols are reviewed at the GMAT level with documented minutes and actions.
  • Ensure synopsis and protocols are reviewed at the PRG.
  • Liaise with the Regional Operation manager to ensure alignment on the proper infrastructure to put in place as well as the expertise of the CRO.
  • Ensure regular updates are provided to GMAT on trial metrics and data.
  • Establish a strong partnership with Regional Operational managers to drive operational excellence in regions and countries for medical affairs clinical activities.
• GMA Leadership Team (LT) Responsibility
  • Member of the GMA LT Oncology.
  • Coordinate with the Global Medical Affairs Oncology Leadership team (GMA LT) to ensure efficient and transparent allocation of Clinical Operation resources, assignment of activities in support of program/trial deliverables, and individual development needs.
  • Develop a hiring plan for GMA and oversee the hiring process.
  • Accountable for keeping a resource model adapted to GMA to optimize resource allocation and reallocation according to the growth of the portfolio and change in strategies.
  • Align across franchise to ensure consistency in execution for all activities (CIS, EAP, IIS management).
  • Interface optimally with QA, Legal/Compliance, Clinical Supply Organization, R&D CE, to seek input or feedback or alignment in a timely manner when needed.
• Process/Policies
  • Develop and implement process standards and tools to achieve excellence in trial operations and management.
  • In collaboration with key stakeholders, drive implementation globally in a manner that creates consistency, efficiency, and a high level of compliance within GMA across compounds and projects.
  • Serve as a knowledge source for clinical operations staff on processes related to trial deliverables and coordinate knowledge sharing.
  • Author/reviewer for clinical SOPs.
  • Support the development of clinical operations-related Corrective and Preventative Action (CAPA) plans for issues of non-compliance if applicable.

Requirements

• Education Qualifications
  • Bachelor's Degree required; degree in life science/healthcare preferred.
  • Advanced degree preferred.
• Experience Qualifications
  • 10 or more years of related overall experience required.
  • 4 or more years of pharmaceutical clinical research experience preferred.
  • 4 or more years of people management and development experience, this may include management in a matrix environment. Global people management required.
  • Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and programs preferred.
  • Mindset of putting the patient first, as well as a values-driven leadership style where integrity drives all behaviors, decisions, and actions preferred.
  • Strong management, interpersonal, and problem-solving skills preferred.
  • Extensive knowledge of the clinical development process, regulatory requirements, and GCP preferred.
  • Proven capabilities in clinical operations process improvements preferred.
  • Considerable organizational awareness, including significant experience working cross-functionally and responsibility for internal resource estimation/allocation preferred.
  • Understand the importance of involving and including key stakeholders on a timely basis to ensure transparency, awareness, and to optimize the decision-making process and timelines of implementation preferred.
  • Medical/scientific knowledge of Oncology and/or Hematology preferred.
  • Forward thinker looking to advance the mission and values of the company preferred.
  • Demonstrated vendor and project management experience preferred.
  • Ability to apply analytical and problem-solving skills in the identification of emerging risks and to collaboratively champion solutions preferred.
  • Proven ability to work with minimal supervision in a cross-functional matrix environment preferred.
  • Demonstrate the ability to lead and influence others and work successfully in a matrix environment with internal and external team members preferred.
  • Highly organized and detail-oriented preferred.

Travel Requirements

Ability to travel up to 20% of the time. Standard office-based physical demands, minimal travel.

Pay

Salary Range: USD $271,500.00 - USD $452,500