Director, Clinical Science

Daiichi Sankyo; United States; Remote; USD 90,000 - 160,000; Full time

Job summary

An established industry player is seeking a Clinical Trial Manager to oversee complex clinical trials and regulatory submissions. This role involves strategic planning, collaboration with key opinion leaders, and leading project teams to ensure successful trial execution. With a focus on innovative therapies, the position offers a chance to impact healthcare globally. Join a dynamic team dedicated to addressing unmet medical needs and advancing pharmaceutical science. If you have a strong background in clinical development and a passion for innovation, this opportunity is perfect for you.

Qualifications

• Master's Degree or equivalent preferred; PharmD or PhD preferred.
• 7+ years with PharmD, PhD, or relevant clinical experience.

Responsibilities

• Oversee medium to high complexity clinical trials and prepare regulatory documents.
• Lead or contribute to study strategy and execution, managing risks and recruitment.
• Draft responses to regulatory bodies and interpret study results.

Skills

Clinical Trial Management

Regulatory Strategy

Biomarker Strategies

Data Interpretation

Collaboration with KOLs

Education

Master's Degree

PharmD

PhD

Job description

Join a Legacy of Innovation 125 Years and Counting!

Daiichi Sankyo Group is dedicated to creating and supplying innovative pharmaceutical therapies to improve healthcare standards and address unmet medical needs globally, leveraging world-class science and technology. With over 125 years of expertise and a presence in more than 20 countries, Daiichi Sankyo employs 18,000 people worldwide, focusing on oncology, rare diseases, and immune disorders, aligned with its 2025 Vision to become a global pharma innovator.

Job Summary:

The role oversees one or more medium to high complexity clinical trials, including pivotal studies for regulatory submissions. Responsibilities include preparing regulatory documents, managing CROs, participating in regulatory strategy, drafting protocols, and serving as the point of contact with regulatory agencies. The position may also represent Clinical Development in project teams, potentially as a Global Clinical Lead.

Responsibilities:

1. Study Strategy: Lead or contribute scientifically/medically; provide strategic direction for large or complex Phase 2 studies; collaborate on biomarker strategies; prepare for regulatory meetings.
2. Study Planning and Execution: Provide input on trial milestones, manage risks, oversee recruitment and retention, and coordinate with external committees and KOLs.
3. Study Outputs: Draft responses to regulatory bodies, ensure appropriate biomarker and PK/PD measurements, review clinical data, lead dose-escalation meetings, and interpret study results.
4. External Collaboration: Lead advisory panels, interact with KOLs, and foster collaborations with institutions like NCI.
5. Scientific and Program-Related Activities: Represent the study team, develop development and biomarker strategies, interpret preclinical/clinical data, and lead project teams.
6. Additional Activities: Engage with KOLs, contribute to business development, and participate in portfolio decisions.

Qualifications:

• Master's Degree or equivalent preferred; PharmD or PhD preferred; postgraduate training in TA or related specialty is a plus.
• 7+ years with PharmD, PhD, or relevant clinical experience; 10+ years with a Master's degree and relevant experience.

Travel:

Ability to travel up to 30%, including international travel.

Daiichi Sankyo is an equal opportunity employer, considering all qualified applicants without discrimination based on protected characteristics.