Associate Director GMA Oncology Publications-AML

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, Global Medical Affairs Oncology Publications works with Director, GMA Oncology Publications, to independently develop publication plans, drive the execution of publication projects of assigned products, and support other GMA Oncology activities as needed.

Responsibilities:

• Collaborate with Global and Regional Medical Affairs and various cross functional teams to develop publication plans of assigned GMA Oncology products.
  • Leads the planning, execution and delivery of publication projects to ensure high quality and timely delivery of scientific publications.
  • Manage publication activities in Datavision publication management software, including internal and external review and collection of authorship agreements, financial disclosures, and author approvals.
  • Ensure documentation of compliance with authorship and publication guidelines as stipulated by the International Committee of Medical Journal Editors (ICMJE) and Good Publication Practice for Communicating Company-Sponsored Medical Research (GPP).
  • Work with and oversee publication vendors to ensure deliverables are of high quality, delivered in a timely manner, and in budget.
  • Liaise with internal and external stakeholder, including authors, researchers, investigators, GMA medical leads, R&D clinical leads, bio stats and Publications Committee members on publication activities.
  • Lead study publication committee discussions, including monthly, quarterly, and yearly publication update meetings as needed.
    • Manage timelines of publication output
    • Facilitate study Publication Committee discussions
    • Liaise with internal & external authors, academic research organizations, and study investigators
    • Manage vendor budget and activities
    • Oversee the quality and timeline of vendor work
    • Collaborate with study medical lead and biostat to ensure availability of necessary data
    • Coordinate author review/approval & internal review approval
    • Abstract/manuscript submission with vendor support
    • Facilitate response to journal reviewer comments/requests
    • Publication tracking and announcement, in coordination with MI/E
  • Support global medical communication plan development by collaborating with GMA team
• Align with the Director Publications and respective team members to ensure robust publication plans for the Therapeutic Area and respective products.
• Lead and facilitate Publication Review Committee(s) discussion.
• Manage vendor budget and activities and Oversee the quality and timeline of vendor work.

Qualifications

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

Education/Experience:

• PharmD, or PhD in Health Sciences preferred; Bachelor's Degree or Advanced Degree may be considered based on years of experience/qualifications.
• Minimum of 3 - 5 years of pharmaceutical industry, clinical, and/or academic experience or 8 years of medical writing experience for PharmD, or PhD; Minimum of 5 years of pharmaceutical industry experience or 7 years with publication/communication agency for Bachelor's or Master's degree.
• Proven track record of working successfully with cross-functional teams to achieve goals. Experience with publication planning is required.
• Experience with clinical trials and international work experience are preferred.
• Excellent written and oral communication skills, particularly strong formal presentation skills; strong interpersonal skills; possession of strong scientific analytical skills; excellent planning and organizational skills; experience in managing budgets; understanding of good publication practices and guidance; proficient in Datavision. Supervisor provides recommendations as to most appropriate means to achieve department objectives, as needed.
• Basic knowledge of clinical development process and appropriate application of biostatistics; Oncology experience is strongly preferred; proficiency using standard software suites
• Ability to travel up to 20%

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 Publications-AML

City
Basking Ridge

Functional Area
Global Medical Affairs Oncology

State
New Jersey