Director, GMA Operational Excellence in Bernards, NJ at DSI

Date Posted: 3/7/2018

Job Snapshot

Job Description

About Daiichi Sankyo Cancer Enterprise
The vision of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science Franchise, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

Job Summary

Drive medical compliance standards for business implementation across all key Oncology Medical Affairs activities, in close collaboration with cross-functional and regional stakeholders. Assess compliance risks and operational gaps, in conjunction with key stakeholders (legal, compliance, QA and GMA subject matter experts), to develop and implement a risk mitigation plan


Establish & maintain Global procedures for GMA activities:

Establish a sustainable process for development and implementation of global policies and procedures for MA activities in collaboration with QA and other stakeholders, including requirement for local implementation

Create a sustainable model for content development and maintenance of Global MA SOPs and AOPs, ensuring appropriate involvement of all key stakeholders across functions and at Global/regional and local level. Serve as lead author, as appropriate

Establish & implement process for assignment and tracking of mandatory trainings for GMA associates, in collaboration with QA

Lead activities to operationalize Medical Affairs SOPs and process changes in alignment with key functions and regions to ensure sustainable implementation, in particular as it relates to roles & responsibilities. Implement strong change management plan to promote sustainable culture of quality and compliance focused mindset

Oversight of GMA activities from a Medical Standard perspective:

Develop strategic plan to establish infrastructure for proactive oversight of MA activities (self-inspection plan, quality checks, audit/inspection readiness). Ensure scalability as MA activities increase to support 2025 cancer enterprise strategy

Develop a Strategic plan for systems/tools that will be needed to have worldwide view of MA activities and appropriate oversight of performance and quality metrics

Establish KPIs, define/develop clear processes and dashboard for tracking & managing them, ensuring effective status updates at Business Reviews

Establish & maintain effective communication channels to raise awareness of compliance related matters across global, regional & country medical associates

Audit & Inspection activities:

Establish a consistent approach to audit, inspection & deviation & CAPA management across Medical Affairs

Ensure strong remediation plans for findings and deviations identified during audits, inspections or process control checks; lead activities and support GMA team during audits 7 inspections


Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.


Qualified candidates will have a Bachelor Degree in Science or Business Administration from an accredited college or university

  • Have strong knowledge on operational aspects of medical affairs activities. Knowledge and/or experience in leading medical affairs oversight & governance activities preferred
  • Awareness of external trends and changes in regulation in order to proactively adjust internal processes
  • ≥ 5 years of experience in pharma at local, regional and/or Global level
  • Ability to facilitate and influence decision making to driver results
  • Proven ability to drive pragmatic solutions to complex problems
  • Strong change management skills to drive and sustain a culture of high ethical standards and compliance
  • Ability to foster an environment of trust which encourages associates to proactively bring forward issues and seek guidance
  • Expertly lead and manage large, cross-functional, global teams to achieve high performance
  • Build strong internal and external relationships with diverse stakeholders that maximize alignment and organizational effectiveness
  • Can effectively manage oversight of different and diverse activities(clinical program, publication, medical education, Advisory boards)
  • Effectively develop, communicate, and drive a long term vision and plan for oversight of medical affairs activities, anticipating and addressing potential issues
  • Display enterprise leadership in all aspects of the role by gaining alignment across functions and regions
  • Integrate subject matter expertise and cross-functional perspectives to ensure that proposed solutions effectively meet the needs of all stakeholders
  • Expertly manage ambiguity and highly complex situations

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.