Senior Director, Oncology R&D Functional Excellence Position Available In Somerset, New Jersey

Job Description:

Join a Legacy of Innovation 125 Years and Counting! DaiichiSankyo Group is dedicated to the creation and supply of innovativepharmaceutical therapies to improve standards of care and addressdiversified, unmet medical needs of people globally by leveragingour world-class science and technology. With more than 125 years ofscientific expertise and a presence in more than 20 countries,Daiichi Sankyo and its 18,000 employees around the world draw upona rich legacy of innovation and a robust pipeline of promising newmedicines to help people. In addition to a strong portfolio ofmedicines for cardiovascular diseases, under the Group’s 2025Vision to become a “Global Pharma Innovator with CompetitiveAdvantage in Oncology,” Daiichi Sankyo is primarily focused onproviding novel therapies in oncology, as well as other researchareas centered around rare diseases and immune disorders.

JobSummary:

A cross-Oncology Development Medical Doctor positionreporting to the Head Clinical Development Functional Excellence.

This position complements CSPV and GMA efforts with a comprehensiveand all-encompassing approach to coordinate activities, under theleadership of the Head of Functional Excellence, across keyfunctions to improve the benefit-risk in patients treated withinthe oncology compounds throughout the course of clinicaldevelopment through the commercial setting. In this role, theincumbent will contribute to creation and improvement of ClinicalDevelopment processes.

Job Description:

Execute an overarchingsafety program tailored for AEs from end-to-end: understandingpredisposing non-clinical and clinical factors, diagnosis,effective management during clinical trials and beyond in postapproval setting. Responsible for the execution of key safetyinitiatives aimed at preventing, mitigating, and addressingcritical safety issues including but not limited to protocolamendments, Dear HCP letters and key medical education initiatives.

Develops prospective contingency plans for management of assignedsafety risks across projects; Clearly defines priorities andhigh-level execution plans across and effective alignment within(e.g. with translational research, clinical operations, clinicaldevelopment, medical affairs CSPV and other internal groups) andoutside of Daiichi Sankyo (e.g. clinical trial sites, CROs,collaboration partners); Supports effective direct communicationwith clinical sites in collaboration with clinical developmentstaff. Consults with KEE’s for advice on complex patient safetyissues. Communications lead with HCP’s (PI’s, sub- PI’s, nurses) atthe site level to ensure that patient safety with respect to thesafety risk assigned remains top of mind in the context of patientmanagement in the clinical trial setting and in the real-worldsetting. Contributes to creation and improvement of ClinicalDevelopment processes.

Education:

MD required; prefer Boardcertification in Oncology.

Experience:

At least 7 years ofexperience in pharmaceutical industry. At least 2 years in PatientSafety. At least 2 years of experience in Clinical Development. Atleast 2 years of Oncology experience.

Competencies:

An impeccableoncology clinical and medical expert with proven credibility andexperienced in patient safety and clinical development. Experienceworking in a matrix environment and on cross-functional teams.

Travel:

Local and global travel might be required up to 20% DaiichiSankyo, Inc. is an equal opportunity/affirmative action employer.

Qualified applicants will receive consideration for employmentwithout regard to sex, gender identity, sexual orientation, race,color, religion, national origin, disability, protected veteranstatus, age, or any other characteristic protected by law.