Director, Patient Safe Use in Basking Ridge, NJ at DSI

Date Posted: 7/29/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 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 cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

In close collaboration with Executive Director Patient Safe Use in Global Oncology, this position is responsible for coordinating and supporting all enterprise wise approaches to safe use of DS-8201, U3-1402, 1062 and all other ADCs.

The Director Patient Safe use function complements CSPV efforts with a more comprehensive and all-encompassing approach to coordinate activities across key functions to minimize the risk and establish monitoring and management guidelines for identified risks in patients treated with ADCs throughout the course of clinical development through the commercial setting. The role also covers development of training materials and delivery of trainings to the investigators.

The position is responsible for contributing to safety input of global or regional studies within the Oncology/ADC franchise. Providing medical scientist support to the design, conduct, monitoring, data interpretation and reporting of safety data across Oncology/ADC Clinical space. Support the Clinical ownership of the patient safety risk assessment for the assigned trials/product(s), strategically as well as for emerging safety information. Bring clinical understanding and judgment to the patient safety risk perspective in benefit risk assessments. Ensure awareness of projects’ adherence to Good Clinical and Pharmacovigilance Practice and regulatory requirements. Support development of the functional safety strategy or acting as a medical scientist expert of the functional safety strategy. Contribute to strategy and plans to optimize the safety profile of Oncology/ADC drugs in development.

Responsibilities:

Partners with function medical scientists and cross functional stakeholders including Patient Safety and Global Medical Affairs to provide strategic input into plans to develop optimized implementation of the safety management of relevant compounds. Develops and manages patient/site-facing materials and CRA training materials; Supports training initiatives and safe use awareness activities.

Creates, maintains, and controls a library of Safe Use Educational slides to be used for Investigator Meetings, Site Initiation Visits across assets.

Delivers Project management functionality of Patient Safe Use Task Force to ensure follow up and completion of actions; ensures adherence to project timeline; Leads the set up and management of Advisory Board meetings related to the Patient Safe Use initiatives, including set up of contracts, budget, and meetings.

Independently integrates and analyzes safety data from multiple sources, such as CSPV, QCP and Preclinical Safety group to deliver comprehensive conclusions.

Reviews sections of study protocols related to clinical safety for consistency across the ADC program. Authors specific sections of patient safety related documents including informed consent forms and integrated safety reports (beyond DSUR, IB). Supports development of efficiencies to streamline study level operations related to safety.

Contributes to regulatory communication and preparation of high- level documents.

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

Education/Experience:

Bachelor’s in science or advanced degree (e.g. Pharm D, MS, PhD)

7 years in Clinical Research in pharmaceutical company environment. 5 years of clinical research experience necessary with advanced degree

Proven leader of cross-functional delivery teams. High level of project management competency

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.