Senior Director, Early Development Team Lead _Immunology
Otsuka Pharmaceutical Co., Princeton, New Jersey, us, 08540
Key Role Accountabilities:
Strategy & Execution
Leads Early Development teams to deliver early phase assets through clinical PoC, that supports go/no-go decisions for further development.
- Engages EDT members and cross company stakeholders to devise and implement an agreed development strategy for early phase portfolio assets through clinical PoC, aligned with late phase Development and Commercial.
- Effectively engages with and utilizes governance and advisory bodies to agree, revise and progress asset development plans proposed by the EDTs.
- Continually analyzes, progresses, and engages EDT members and stakeholders to solve problems and deliver data-driven decisions.
-Ensures that the EDT delivers to Full Development assets that meet robust Target Reimbursable Product Profiles that can achieve pricing, reimbursement, access and puts forward recommendations when these criteria cannot be met.
- Ensures the process and output of the team meets set milestones, within timelines & budget while remaining cognizant of opportunities to streamline development without compromising quality.
- Engages senior leaders and functional area stakeholders to ensure alignment of program strategy and operational plans with functional area capabilities.
Leadership & Matrix Alignment Works with EDT to set goals and objectives for asset development; ensures aligned functional and individual objectives (for self and team members) across the matrix to accomplish the asset development plan. - Oversees relevant sub-teams and ensures clear goals and objectives are in place, provides feedback and coaching, and holds sub-team leaders accountable for key deliverables. - Facilitates objective and effective decision making among team members. - Builds productive relationships with functional heads of all groups that interact with the EDT, and partners with them to advance the EDT goals and secure resources. - Communicates key program information, risks, and milestones, and ensures information flow across key stakeholders, governance teams, functional leaders, team members, etc.
Experiences and expertise required: MD, PhD, DVM, PharmD, MBA, or equivalent advanced biology degree - Experienced drug developer with 10+ years experience in the drug development process, preferably with experience in early phase development covering both biologics and small molecule - Experience in managing and leading high performance, cross-functional teams (Matrix) or complex organizations. - Objective matrix team leader with demonstrated ability to frame issues, ask the right clarifying questions, and rationalize decisions in a cost disciplined manner, with an enterprise view - Strong understanding of relevant regulatory health authority expectations and regulations for drug development - Working knowledge of all functional areas of exploratory development, including, CMC (small molecules and biologics), biology, toxicology, clinical pharmacology, ADME/DMPK, early clinical development, etc. - Ability to create a clear purpose, global vision, strategies and key priorities for competing successfully in the evolving pharmaceutical and health care industry - Ability to multitask across multiple exploratory development assets. - Demonstrated ability to successfully and effectively cooperate, collaborate and work across functional boundaries - Ability to review and interpret scientific data and incorporate emerging information, feedback and scientific progress (internal and external) into development actions.
Leadership & Matrix Alignment Works with EDT to set goals and objectives for asset development; ensures aligned functional and individual objectives (for self and team members) across the matrix to accomplish the asset development plan. - Oversees relevant sub-teams and ensures clear goals and objectives are in place, provides feedback and coaching, and holds sub-team leaders accountable for key deliverables. - Facilitates objective and effective decision making among team members. - Builds productive relationships with functional heads of all groups that interact with the EDT, and partners with them to advance the EDT goals and secure resources. - Communicates key program information, risks, and milestones, and ensures information flow across key stakeholders, governance teams, functional leaders, team members, etc.
Experiences and expertise required: MD, PhD, DVM, PharmD, MBA, or equivalent advanced biology degree - Experienced drug developer with 10+ years experience in the drug development process, preferably with experience in early phase development covering both biologics and small molecule - Experience in managing and leading high performance, cross-functional teams (Matrix) or complex organizations. - Objective matrix team leader with demonstrated ability to frame issues, ask the right clarifying questions, and rationalize decisions in a cost disciplined manner, with an enterprise view - Strong understanding of relevant regulatory health authority expectations and regulations for drug development - Working knowledge of all functional areas of exploratory development, including, CMC (small molecules and biologics), biology, toxicology, clinical pharmacology, ADME/DMPK, early clinical development, etc. - Ability to create a clear purpose, global vision, strategies and key priorities for competing successfully in the evolving pharmaceutical and health care industry - Ability to multitask across multiple exploratory development assets. - Demonstrated ability to successfully and effectively cooperate, collaborate and work across functional boundaries - Ability to review and interpret scientific data and incorporate emerging information, feedback and scientific progress (internal and external) into development actions.