Provides strategic planning, scientific and medical support, and is responsible for overseeing the development and implementation of medical and scientific communication platform, research strategies including post-approval investigator initiated research, phase 4 and contracted research. In addition, provides medical input into the long-term vision and growth strategies for the compounds within the related portfolio of TPUSA.
Serve as the in-house medical and scientific expert for drugs within assigned therapeutic area and represent medical affairs on the following committees: Functional and Commercial Planning Teams, strategic Global Program Strategy Teams (GPTs), Medical-Regulatory-Legal (MRL) Teams, Investigator Initiated Sponsored Research (IISR) and Medical Affairs research Committees, Medical Education Committee, Publication teams, and other teams as designated.
Interact internally with and support colleagues from Alliance Management, Business Development, Government Affairs, Marketing, and Sales.
Develop and maintain relationships with key external experts through Professional Associations, Professional Meetings and Conferences, etc. in support of common scientific objectives.
Seek input and alignment with key internal stakeholders on therapeutic area initiatives (e.g., research gap analysis, communication plans, novel indications, etc.).
Assist in managing the budget for the specific Cost Center and provide direction and oversight for the US MA overall therapeutic area budget.
Provide medical and scientific direction and review for pre- and post-launch regulatory strategies (which may include label (PI), protocols, NDAs and Supplemental NDA s, etc.).
Either directly, or indirectly through supervision, oversee the medical review and sign off of promotional pieces in support of the Medical-Regulatory-Legal committee for products within your therapeutic area(s).
Participate in the publications strategy for assigned compounds by providing scientific and publication planning input, including review and sign off of materials for medical/scientific presentations and publications.
Interact internally with senior level management requiring negotiation to guide the overall activities of the specific compound and therapeutic area.
Develop and maintain relationships externally through Advisory Boards, Professional Associations and Meetings to achieve Takeda s scientific objectives.
Participate in external alliances and partnerships to further Takeda's scientific objectives.
Provide support for departmental initiatives and other duties as assigned.
EDUCATION, EXPERIENCE AND SKILLS:
MD degree or DO degree preferred with at least 7 plus years of experience in pharmaceutical industry and/or academic research, relevant clinical experience, or equivalent combination.
Other advanced degreed professionals (PharmD, Ph. D) considered depending on past relevant pharmaceutical industry experience, and/or clinical work, research, or academic endeavors.
Experience with publication activities, congress presentations and public speaking.
Life cycle management experience.
Prior experience in Medical Affairs.
Board certification in therapeutic are related to position.
Maintain minimum standards of education/certification in individual professional discipline.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to drive to or fly to various meetings/client sites limited overnight. Some international travel may be required.
Manual dexterity required to operate office equipment (i.e. computers, phones, etc.)
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Due to travel, the work environment includes exposure to both inside and outside working conditions. Temperature and length of exposure varies depending upon meeting location and transportation.
Industry Knowledge understands the pharmaceutical industry regulations governing medical functions within industry activities and medical regulatory process.
Product Knowledge understands medical/therapeutic impact of products; understanding of potential product applications.
Takeda Operations understands Takeda s operating structure and methods including a thorough knowledge of the foreign-owned parent company.
Leadership ability to provide ongoing feedback and coaching to employees and guides leaders within the department in doing the same.
Leadership ability to use confidence, decisiveness and a willingness to listen to influence and engage others in the accomplishment of functional goals.
Budget Management - ability to develop an operating budget to monitor and control expenditures; manages variances between budgeted and actual expenditures of time, dollars, and personnel.
Communication ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
Analytical Skills ability to analyze a wide variety of scientific data including financial figures and market research data to make management decisions.
Business Process Acumen - ability to apply the knowledge of Takeda s core business capabilities to help the organization meet its goals and desired outcomes.
Strategic Approach ability to predict broad-based changes in business partner environment and translates them into functional strategies to continually meet business partner needs.
Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables and models for others to use.
Knowledge Management ability to document resolution to issues and or customer concerns in a manner that ensures reusability of that resolution.
Pharmaceutical Industry Acumen -ability to develop and implement business solutions based on trends, opportunities, needs, and market direction within the pharmaceutical industry.