Job Summary

The Research Pharmacist will be responsible for providing input in the development, management and training of investigational products at a program and protocol level (i.e. Investigational Product (IP) manuals/pharmacy manuals/Dose Preparation Instructions (DPI) for utilization by clinical sites). The Research Pharmacist will also contribute to the review and approval of template documents for protocols, pharmacy manuals, and DPI. The Research Pharmacist provides expertise on clinical site/pharmacy operations and best practices as well as aseptic preparation guidelines for injectables.

Job Description

Responsibilities

• Support and management of clinical studies for all sponsored trials, as well as Externally Sponsored Research (ESR) customers. Serve as the Subject Matter Expert (SME) for R&D for all questions related to clinical pharmacy practice at sites and IMP or comparator related questions.
• Provide strategic leadership of oversight of all clinical site and patient focused training materials. Collaborate with other functional areas as necessary (eg, Clinical Supply Planning and Operations (CSP&O), Chemistry Manufacturing & Controls (CMC), Clinical Operations, etc.).
• Has a focus on strategic and operational excellence; Provide input in Patient Focused Initiatives. Ensure a site-friendly and patient-friendly focus for all site/patient facing materials. Provide input on the design of Pharmacy Manuals, Patient Wallet cards, Patient ILD Educational information and other relevant patient or site-facing materials
• Deliver excellence in clinical trials through the use of harmonized tools, processes and systems, to deliver cost-effective, high-quality IP Handling information and training according to agreed timelines
• Proactively ensure quality and compliance through risk identification and mitigation plans, strategic planning and execution, and overall design input.
• Serve as regular reviewer on the Protocol Review Group (PRG).
• Responsible for reviewing all protocol profiles, v1 protocols, and protocol amendments with the perspective of a clinical pharmacist, considering both clinical and logistical concerns at the site level. Work with study teams to resolve feasibility concerns. Ensure consistent guidance is provided to sites between protocol and other related documents (eg, pharmacy manual, DPI). Provide feedback to ensure protocols are written in a site-friendly manner to avoid any feasibility concerns.
• Serve as a regular review for Externally Sponsored Research (ESR) concepts and high-risk protocols.

Qualifications

Education Qualifications

• PharmD, or equivalent, required

Experience Qualifications

• 7 years of Clinical Pharmacy or equivalent pharmaceutical/biotech industry experience. preferred
• Hospital pharmacy experience required.
• Completion of a post-PharmD Industry Fellowship or pharmacy practice residency is preferred

Travel Requirements

• Ability to travel up to 10% of the time.

Competencies

• Proven leader of cross-functional teams
• Open, active and inspiring communicator (written and verbal) with professional communication style and business behavior in interactions within and outside of Daiichi Sankyo.
• Confident and influential approach, ability to provide clear instructions/guidance to teams at the same or higher levels in a global organization
• “Can do”-mentality
• Learning Agility, creativity and ability for development of new concepts
• Make independent choices and take responsibility for own actions
• Quick in the uptake of difficult and complex situations, anticipates potential problems, acts quickly / proactively and resolves them effectively
• Ability to motivate, train and lead teams in a matrix organization, understands the needs of others and creates a positive working environment
• Ability to lead in a global setting and to successfully operate across diverse cultures and geographies