Director, Clinical Development - Specialty Medicine at Daiichi Sankyo, Inc. in Basking Ridge, New Jersey

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. 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.



Summary



The primary responsibilities of this position are the plan, design, and conductance of early development clinical studies; the preparation of regulatory documents to file IND and report studies; and the representation of the specialty medicine (SM) clinical development (CD) function on study and project teams. This position requires significant understanding of clinical research for drug development, from hypothesis formulation to subject enrollment, use of statistics, assessment of endpoints, and operational execution. This position effectively works independently, interacting with study and project teams, senior management, and outside advisors and vendors.



Responsibilities




Study Planning: Plans and designs studies consistently with product development and clinical development plans. Studies the literature and consults with internal experts and external advisors and advisory boards, contributing to identifying these experts and assembling these boards. Identifies the desired study population by delineating subject eligibility criteria for study participation and pursues the demonstration of drug activity by selecting clinical and mechanistic endpoints. Act as clinical study leader.



Study Execution: Collaborates with Biostats Data Mgmt. & Data Ops. for statistical support and data capturing; with Clinical Safety and Pharmacovigilance for safety endpoint definition and adverse events reporting; with Translational Medicine and Clinical Pharmacology for biomarker and PK endpoints choice; with Clin. Ops. to select and establish effective communication with external vendors and to contribute to study logistical conductance; with Regulatory Affairs to align study with health authority requirements; with Quality Assurance to guarantee subject safety and privacy and data integrity.



Additional Study-Related Activities: Contributes to the preparation of regulatory documents for IND filing (e.g., IND modules and ICF), collaborating with preclinical research functions (e.g., Pharmacology and Toxicology); prepares and presents material for first-in-human committees; prepares study reports, collaborating with Medical Writing; is responsible for or contributes to (in conjunction with a CRO medical monitor) study medical monitoring (MDs only).



Additional Activities: Represents Clinical Development on study and project teams; presents to senior management; supports business development by evaluating in-licensing opportunities (e.g., conducting due diligence) and preparing assets for out-licensing.


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


Education Qualifications (from an accredited college or university)

• MD or equivalent required


• Postgraduate training in TA or related specialty

Experience Qualifications

• 4 or More Years relevant clinical experience required

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. Apply Now