Director, Project Lead (Back-of-the-eye)

COMPANY DESCRIPTION

At Santen, we're innovating therapies to improve the quality of life for patients worldwide. Our single focus in ophthalmology enables us to challenge unmet needs in the field-through passionate research, successful collaboration, and clarity of commitment. With over 130 years of investigative insight, Santen remains committed to the discovery, exploration, and development of ophthalmic therapies. As a global company, Santen is expanding to accommodate new and evolving initiatives in ophthalmic research, regulatory management, production, marketing, or distribution. Our clinical development network spans three continents, with centers in Europe, Japan, and the United States.

We are in search of top talent to help us meet our aggressive and important goals.

ABOUT THE POSITION:

The (Global) Director, Project Lead develops and owns the Master Development Plan and ensures that it is fully developed by the Global Project Team, supported by appropriate tools and processes and managed effectively by the Project Manager. This position falls within the Project Management Group and will lead the Back-of-the-eye (BOTE) program. The Project Lead (PL) works through the GPT to get input/buy-in to the Master Plan from corporate and regional functions. Additionally will:

• Coordinate with function heads to secure the participation of the best / optimal talent for the project in collaboration with Project Manager (PM)
• Proactively manages the Target Product Profile(s) for specific projects; recognizes that it is the key underpinning of the product development strategy and the foundation upon which commercial value is assessed

ESSENTIAL DUTIES AND KEY DELIVERABLES:

• Reporting into his/her GM/VP of Project Management Group (PMG), the Project Lead has a highly visible role and is accountable for developing a Master Development Plan and driving a program into the clinic, after proof of concept to regulatory submission/approval
  • Integrates data from both the Scientific Assessment and the Marketability Assessment to create the Target Product Profile
  • Seeks input from Global Project Medical Director and collaborates with other colleagues and executives in Research, Clinical Science, Medical Affairs, Commercial Lead, BD, Portfolio and Program Management etc. as well as Health Economics and Outcomes Research to develop the Master Plan
• Is responsible for creating and leading a Global Project Team for development, delivery and monitoring of the Master Plan:
  • In collaboration with Project Manager, The PL defines the team's structure, roles and accountabilities and is accountable for ensuring that the GPT is an engaged, effective, functioning unit that is focused on driving performance and meeting unmet patient needs in alignment with Santen's strategic goals and objectives
• Accountable for ensuring that the Master Plan, Clinical Development Plans and study protocol designs are interconnected, congruent, consistent and in accordance with the Target Product Profile
  • Ensures that plans and protocols are developed in line with expected ethical, quality, compliance and safety standards and that they maintain scientific integrity
• Leads regular reviews of program progress against specific milestones and leads the decision-making process on whether to recommend advancing, stopping or re-directing the program; based on the analysis and decisions, communicates recommendations to executive management
  • Maintains up to date knowledge and understanding of risk factors and ensures risk mitigation plans are in place
  • Assesses new opportunities for the program that arise as a result of additional scientific research, clinical trial endpoints, data outcomes, competitor or market activity and verifies strength and validity of the TPP
  • Provides regular, scheduled, consistent and accurate reports to executive management
• Ensures active use of Santen's knowledge capture and management process / system to store and share program data appropriately with key stakeholders, colleagues and partners
• Develops relationships with selected external development partners (in agreement with executive management) that have skills, technology and resources not available within Santen and that will advance the program's goals and agenda
• Ensures that self and the GPT initiates, maintains and fosters relevant relationships with external academic and scientific networks in support of advancing the goals and objectives of the program
• Implements appropriate performance metrics and measurement systems for the global program

QUALIFICATIONS:

• Scientific degree, preferably a Ph.D. in a relevant scientific field
• Strong commercial acumen
• Strong Ophthalmology acumen, especially Back of the eye field (retina related disease, etc.)
• 10 - 12 years of Pharmaceutical/ Medical Device industry experience. In addition, Program Leader, Project Leader or Program Leader experience is preferable