The Development In-Licensing Manager is responsible for management of complex scientific- and development-related analysis to support decision-making and planning for in-licensing opportunities. This position provides guidance, input, and direction into the analysis and clinical development planning for new in-licensing opportunities. This position improves cross-functional collaboration by providing adhesion that enables the creation of more effective work processes by accelerating complex, information-intensive processes, increasing efficiencies, and increasing cross-functional communications. This position has a high level of interaction with PDD functional representatives, the PDD Therapeutic Area Heads, cross-divisional stakeholders, and senior management to ensure that the scientific analysis is clear and the therapeutic area strategy is clearly integrated into the clinical development plan.
Represents PDD In-Licensing Management on a global basis to GLBD and the Takeda organization (CMSO, PRD, CMC, IP, Commercial).
- Provides adhesion across functions to lead the comprehensive technical assessment of in-licensing opportunities and creation of clinical development plans.
- To ensure clarity and mutual understanding regarding individual projects, partners with GLBD members and SPMs on a regular basis to ensure changes in project scope and deliverables, are understood and communicated.
- Provides a strong, cooperative interface with all departments in PDD and inter-divisionally to ensure collaboration and understanding among teams during the evaluation of in-licensing opportunities.
Ensures the global alignment of clinical assessments and strategies to provide comprehensive, reliable pipeline recommendations to global Takeda Senior Management that facilitate successful business decisions and the initiation of clinical development programs.
Continuous improvement of the global PDD IM process
- Ensures quality and consistency of PDD assessments across therapeutic areas by performing and documenting complex scientific- and development-related analysis to support decision-making and planning for in-licensing opportunities. This position provides guidance, input, and direction into the analysis and clinical development planning for new in-licensing opportunities. Creates and reviews clinical development plan Gantts and budgets, as needed.
- Responsible for high-level strategic analysis of complex issues to identify project risks and challenges and mitigation plans to meet them. This analysis will be used to provide decision makers with important information.
- Collaborates with the PDD team and Therapeutic Area Head and cross-divisional stakeholders to identify and resolve scientific, regulatory, commercial, scheduling and budget issues related to the project in a timely manner.
- Prepares presentations for management reviews and updates.
- For new in-licensing projects or changes in project scope:
- Responsible for communicating with GLBD to understand the project background, scope, and timeline of deliverables. Requests PDD functional representative assignments from function heads and regions as needed. Manages changes and communications regarding assignments in a timely manner to manage resources in a dynamic environment.
- Leads continuous improvements of the global PDD IM process.
- Enhances global communication across the PDD functions throughout this process.
Provides training for PDD functional representatives
- Partners with GLBD and PDD functions to create due diligence training.
- Responsible for updating and maintaining PDD report documentation templates.
- Provides training to PDD functional representatives regarding due diligence technical assessments, creation of clinical development plans, and use of report templates and tools.
Responsible for ensuring that PDD deliverables are on track for multiple stakeholders (TAH, GLBD, Commercial, Asia PDD review, Japan PDD review).
- Monitors and reports project progress and status to management. Utilizes project tracking and processes to identify and resolve project progress/issues.
- Partners with the assigned SPM for individual projects on a regular basis to execute the global project according to timelines and ensure consistency among projects.
Scientific and Technical Expertise
Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Knowledge of scientific/technical trends in the Industry that impact Takeda’s current and future business.
Education and Experience
- B.S. degree required; M.S. degree in a scientific discipline preferred
- Minimum of 7 years of cross-functional experience within the pharmaceutical industry.
- Minimum of 4 years of experience participating in or leading a cross-functional development team within the pharmaceutical industry.
- Thorough knowledge of global drug development.
Knowledge and Skills
- Proven superior communication (written and verbal), strategic, interpersonal and negotiating skills.
- Ability to proactively predict issues and solve problems. Ability to come up with creative solutions to complex problems.
- Strategic thinking—ability to approach specific issues/problems with understanding of the larger context.
- Diplomacy and positive influencing abilities.
- Management--Ability to manage multiple tasks of varied complexity simultaneously. Ability to set priorities for a team and meet specific deadlines in a changing environment. Ability to be flexible, accommodating, and to deal with change effectively.
- Excellent organizational skills.
- Ability to articulate and establish processes which impact cross-functionally.
- Ability to exhibit flexibility as cross-functional deliverables of a project are expected in a timely fashion and often change dynamically over time.
- Industry knowledge –understanding of processes and principles unique to the pharmaceutical industry. Expert knowledge in the overall pharmaceutical drug development process, preclinical through post-marketing.
- Scientific knowledge –appreciation of the scientific and clinical impact of a compound within a specific therapeutic area in order to assess global viability.
- Business knowledge –insight into Takeda’s business capabilities and how they affect meeting organizational goals during clinical development.
- Teamwork—ability to foster good working relationships among team members, and work effectively in and contribute to a team environment.
- Microsoft Project Professional, Excel, PowerPoint, Word, and Sharepoint.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires less than 10% travel.
We are driven to improve people's lives.
We are an equal opportunity employer.
No Phone Calls or Recruiters Please.
Takeda Pharmaceuticals - 14 months ago