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Director, Medical Affairs, Specialty and Value Products in Bernards, NJ at DSI

Date Posted: 12/7/2018

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

In alignment with leadership, internal teams and brand needs, the Director, US Medical Affairs Specialty and Value Products will be responsible for the development and execution of the US medical affairs plans for a portfolio of products across multiple therapeutic areas including pain, cardiovascular and metabolic. Working through strategic partnerships with the brand teams, HEOR (Health Economics Outcomes Research), R&D (Research and Development), FMA (Field Medical Affairs), MI&E (Medical Information and Education) and global functions, as necessary, the director will create and implement strategies appropriate to the product lifecycle stage, from launch to post-loss of exclusivity. Depending on the product, this role will be responsible for advisory activities to obtain thought leader feedback; identification and management of key external stakeholders including scientific leaders, payers, and societies; scientific engagement planning and coordination; interpretation of clinical data; ensuring consistency of clinical content and scientific statements across materials; training and education of cross-functional internal colleagues; budget and forecast accuracy; and, providing US input into global development strategy, design, and deliverables, including data generation, scientific communications and publications.

Responsibilities:
  • Serve as the medical lead to develop and execute the US medical affairs plans for a portfolio of products across multiple therapeutic areas including pain, cardiovascular and metabolic. Serve as the scientific/medical resource and engage when necessary with the following: Extended Medical Team (Health Outcomes and Economic Research, Field Medical Affairs, Medical Information and Education), Global Medical and Brand Teams, Marketing, Clinical Development, Regulatory, Legal, Managed Markets, Business Development and Sales Training and, if required, Co-Promote or Alliance Partners, and with other functions as needed. Represent US medical position on assigned global teams. Oversee the evaluation of competitive intelligence information for input into current and future strategies for the therapeutic area as assigned.
  • Serve as the medical lead for scientific communication for the portfolio of products. Create or provide input into the preparation of US/Global publication plans for in-line products. Responsible for the execution of the US medical communication plans (publications, medical slides). Provide critical review of all scientific data disclosures as needed. Responsible for strategic input, planning and implementation of advisory board meetings. Responsible for providing input into Thought Leader/Expert Identification and Engagement activities related to the therapeutic area in collaboration with the VP, Medical Affairs
  • Provide input into the lifecycle plan and participate in the appropriate clinical trial planning process that leads to study approval. Lead the design and implementation of Phase 4 clinical studies, ensuring they are aligned with current regulations and ICH/GCP guidelines as well as therapeutic area strategies and goals. Chair/Lead/Participate as a voting member on the IIS committee and oversee/lead the scientific review of IIS study proposals as assigned
  • Ensure the appropriate utilization of financial and other resources required to achieve the medical objectives; and effectively managing project specific and administrative budgets.

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

Education/Experience:
  • Advanced degree in the Health Sciences is strongly preferred such as PharmD, PhD, or MD; training or experience in a relevant therapeutic area is preferred. Master’s Degree in Health Sciences as a minimum may be considered pending years of experience/qualifications.
  • Minimum of 5 years of pharmaceutical industry, clinical, and/or academic experience for PharmD, PhD or MD; Minimum of 7 years of pharmaceutical industry experience for MS or similar degree in health sciences. Proven track record of working successfully with cross-functional teams to achieve goals. Experience with medical strategies and scientific communication plans is required.
  • Excellent written and oral communication skills, particularly strong formal presentation skills; strong interpersonal skills commensurate with the need to work closely with both outside physicians/ scientists and numerous cross-functional teams, strong managerial skills to effectively lead and motivate staff; demonstrated high proficiency in problem solving ability and possession of strong scientific analytical skills; excellent planning and organizational skills; experience in setting and adhering to departmental budgets; knowledge of scientific methods, research design and medical practices and procedures that would be acquired through clinical experience and clinical research studies.
  • Basic knowledge of biostatistics; proficiency using standard software suites

Ability to travel up to 30% with up to 10% international travel.

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.