Daiichi Sankyo Inc. Associate Director, GMA Oncology Operations in Basking Ridge, New Jersey

9493BR

Auto req ID:

9493BR

Job Description:

About Daiichi Sankyo Cancer Enterprise

The mission 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, 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:

The Associate Director, GMA Oncology Operations supports Global Medical Affairs (GMA) Oncology in adhering to compliance standards for business implementation across all key GMA Oncology activities, in close collaboration with cross-functional and regional stakeholders. Assess compliance risks and operational gaps, in conjunction with key stakeholders (Legal, Compliance, Quality Assurance and GMA subject matter experts), to develop and implement a risk mitigation plan. Ensure mandatory Learning Management System (LMS) training is assigned appropriately, new associates are provided onboarding guidance, and that GMA records are tracked according to expectations and internal SharePoint is maintained.

Responsibilities:

  • Governance and Operational Excellence

  • In collaboration with Governance & Operational Excellence team establish framework for oversight of GMA activities to ensure they are being conducted in alignment with established processes

  • Track progress of key initiatives for GMA Governance & Operational Excellence team and prepare updates of leadership, including status of mitigation plans. Prepare agenda, meeting minutes, and follow-up on action items

  • Support activities related to development of policies, procedures and systems

  • Establish and effectively maintain GMA SharePoint sites

  • Establish process for development & maintenance of Non-Regulated GMA Documents (Guidance/reference documents)

  • Support with establishing 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

  • Support with audit-relevant activities

  • Support with establishing KPIs, define/develop clear processes and dashboard for tracking & managing

  • Establish oversight for implementation of onboarding plans for new hires

  • Record Management Coordinator

  • Serve as the responsible person for records management within Global Medical Affairs

  • Facilitate the drafting/maintenance of the GMA Departmental Records Matrix, including document classification

  • Oversight of departmental records lifecycle – tracking documents from creation through archiving

  • Drive “Records Management Event Days” within GMA

  • Support record management training and education activities

  • Act as a point of contact for Legal Affairs with respect to the Record Management Plan and Legal Holds

  • Escalate issues, as appropriate

  • Training Coordinator

  • Establish & implement GMA process for assignment and tracking of trainings in collaboration with the relevant stakeholders (i.e. QA, etc.)

  • Maintenance and oversight of GMA specific curricula

  • Drive the development of new role specific curricula, as needed

  • Support implementation/roll-out of supplemental training, as requested Dir. Medical Capabilities

  • GMA representative on West SOP Committee, as requested

  • GMA functional coordinator for DSAC APP Committee, as requested

Qualifications

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

Education/Experience:

  • Qualified candidates must have a Bachelor’s degree from an accredited college or university in Science or Business Administration

  • Required:

  • Collaborative, team-oriented and results-focused with a strong compliance mindset

  • Good planning and project management skills

  • Experience in the pharmaceutical industry

  • Ability to proactively identify and propose pragmatic solutions to address issues / risks

  • Excellent analytical, interpersonal, and stakeholder management skills

  • Ability to successfully interact with functionally-diverse stakeholders with associates at the global, regional and local level

  • Proactive team player with an ability to act in a forward-thinking manner

  • Other Preferred Experience:

  • Knowledge and/or experience in medical affairs strongly preferred

  • Track record of operational oversight & governance effectiveness in a matrix environment

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.

Job Title:

Associate Director, GMA Oncology Operations

City:

Basking Ridge

Functional Area:

GDSI Global Medical Affairs Oncology

State:

New Jersey