PRIMARY PURPOSE OF POSITION:
This position reports directly to the Head of Program Management and is seen as a highly visible role. The primary role of this position is accountable for developing the overall development strategy for the assigned Disease Franchise as well as each individual Program with Master Plan (MaP) based on the Target Product Profile within the Franchise. This position will drive the overall Disease Franchise Strategy from proof of concept through market approval and is responsible for creating and maintaining the value of the overall Disease Franchise. A secondary role of this position is accountable for leading a Program(s) within his/her portfolio, if needed. Within each program, he/she will ensure data is integrated from both the Scientific Assessment and the Marketability Assessment in order to create a Target Product Profile for each indication. This position will seek input from the Head of R&D, Functional Heads, other Division Managers, as well as external stakeholders. This position will work with his/her team to develop and execute their Master Plans.
MAJOR DUTIES OF POSITION:
As a Franchise Leader, this position is accountable and/or responsible for:
• Leading and managing the strategy and the direction of a Disease Franchise (a collection of all the programs for Retina, Glaucoma, or Cornea & External Eye Diseases), collaborating with all related internal and external stakeholders.
• Managing and mentoring the Program Leaders (aka Team) within their respective Disease Franchise which includes providing leadership, supervision, strategic alignment and management of the various programs within the Disease Franchise.
• Ensuring that each program within his/her Disease Franchise develops and executes a Master Plan (MaP) which is aligned with the Target Product Profile.
• Maintaining a close collaboration and alignment with all related groups and team to blend cultural & best practices at the strategic and operational level
• Responsible for advocating, sharing and communicating the Franchise information and its updates with any internal and external stakeholders within the company’s information systems.
• Managing, prioritizing resource capacity & develop expertise to support the program / project needs, including implementation of appropriate performance measures and metrics for each program.
• Ensuring that his/her team is appropriately empowered and able to make decisions for their specific areas of responsibility.
As a Program Leader, this position is accountable and/or responsible for:
• Leading the Core Development Team, creating, maintaining and monitoring the Master Development Plan.
• 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
• Determining priorities and areas of focus for the program and sets direction and expectations for the Core Development Team to deliver on the objectives
• Leading 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; and based on the analysis and decisions he/she will communicate recommendations to executive management
•Maintaining up to date industry knowledge, good understanding of critical program risk factors and ensures risk mitigation plans are in place
•Assessing 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
•Providing regular, scheduled, consistent and accurate reports to executive management
• Developing 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.
• Ensuring that self and the Core Development Team initiates, maintains and fosters relevant relationships with external academic and scientific networks in support of advancing the goals and objectives of the program
• Evaluating effectiveness and sustainability of clinical operations and data management delivery models in relation to the program goals and objectives (in-house, outsourcing etc.)
KNOWLEDGE AND SKILL REQUIREMENTS:
• Medical degree and preferably a Ph.D. in a relevant scientific field.
• MBA preferred; proven strong business and commercial acumen.
• Minimum 10 – 12 years of relevant industry experience.
• Experienced phase 3 development through regulatory submission/approval in Europe and/or United States.
• Eight (8+) or more years’ management experience.
• Mature, skillful approach to project management.
• Excellent oral, written and presentation skills.
• Excellent interpersonal skills and proven ability to work in an international team environment with the ability to function and communicate cross-functionally and work effectively with global teams and groups.
• Ability to multi-task and triage without losing focus.
• Ability to build consensus; skillful at negotiation and alignment in a matrix environment.
• Ability to demonstrate passion for project management and a strong aptitude for interpreting business strategy.
• Creative problem-solving, mature approach and dedication to continuous improvement.
This section requires quantitative data that will help provide some measure of the size or scope of the position. Data should be on an annual basis.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. The individual must be able to:
• Spend considerable time at the computer
• Stand, kneel, and stoop for filing
• Use the telephone and speak with external individuals
• Lift up to 25 lbs.
• Travel domestically and internationally without restriction, up to 50%
WORK ENVIRONMENT and ENVIRONMENTAL CONDITIONS:
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.