About the role:
The Medical Director will provide near and long term strategic direction as well as development and oversight of the scientific platform in support of the product strategies for assigned compounds within a specific therapeutic area. You will report to the Senior Medical Director/VP of US Medcal
How you will contribute:
Lead and direct relevant medical responsibilities by providing scientific insight and development of strategy for assigned compounds by participating and leading committees to realize Takeda's overall vision.
Committees may include: Functional and Commercial Planning Teams strategic Global Program Teams (GPTs), various development committees, Medical-Regulatory-Legal (MRL) Teams, IISR and Medical Affairs Research committees, phase 4 / life cycle management Committees, Medical Education Committees, Publication teams , etc. and other teams as designated or as the compounds evolve and progress in development.
Interact internally with senior level Takeda management; advise and negotiate, as required, to guide the overall activities of the specific compound(s) and therapeutic area.
Develop and maintain relationships externally through Advisory Boards, Professional Associations, Professional Meetings and Conferences, etc. to achieve Takeda's scientific objectives.
Assist in managing the budget for the specific Cost Center and provide direction and oversight for the overall therapeutic area budget.
Provide medical direction and review for pre and post launch regulatory strategies (which may include label (PI), protocols, 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 the specific therapeutic area(s).
Participate in the publications strategy for assigned compounds by providing scientific and publication planning input.
Provide input to confidential New Business Development opportunities within the respective therapeutic area of expertise, as required.
Provide support for departmental initiatives that further our business, and support other departments within Takeda such as New Product Planning, Government Affairs, and some TAU related projects, etc.
Other medical and scientific support duties as assigned.
CORE ELEMENTS RELATED TO THIS ROLE:
In collaboatation with TA lead and senior directors contribute to development of TA strategy and lead the tactical execution of medical strategy.
DIMENSIONS AND ASPECTS
Subject matter expertise (Immune deficiency or rare autoimmune neuromuscular neuropathies), a thorough understanding of drug development and roles and responsibilities of a medical affairs function.
In collaboration with senior directors provide leadership, vision and strategic direction for medical unit. Provide career development opportunities for direct reports. Create an inclusive environment that maximizes the contribution of individual team members.
Decision-making and Autonomy
Responsible for tactical implementation of medical strategy for designated therapeutic area.
Participates in cross-functional interactions related to therapeutic area and others as may be assigned. Maintains external interactions with HCPs and other key external stakeholders (Professional bodies, Institutions etc.) as agreed with senior management
Understanding of immune deficiencies and/or rare autoimmune diseases and their pharmaceutical management. Innovative approaches to disease management.
The use of immunoglobulin therapy in the management of immune deficiencies and/or rare autoimmune diseases. Knowledge of competitor products and advances in therapeutic area (drugs and devices).
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
MD degree or DO degree preferred with at least 7 years of relevant clinical practice, research, academic and/or pharmaceutical industry experience.
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 clinical research, publication activities, congress presentations, and public speaking.
Board certification in therapeutic area related to the position
Life cycle management experience
Industry Knowledge - understands 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 - Able to understand Takeda's operating structure and methods including a thorough knowledge of the foreign-owned parent company.
Leadership - demonstrable ability to provide ongoing feedback and coaching to employees and to guide other leaders within the department in doing the same.
Leadership - demonstrable ability to use confidence, decisiveness and a willingness to listen to, influence and engage others in the accomplishment of functional goals.
Budget Management - demonstrable 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 articulately communicate ideas and data both orally and in writing. Communications must be in a highly professional, persuasive and appropriate manner.
Analytical Skills - ability to analyze a wide variety of scientific data including financial figures and market research data to make professional 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 translate 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
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Flexible Work Paths
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Absent an approved religious or medical reason, all US field-based employees must be fully vaccinated for COVID-19, as a condition of employment.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.