This position is responsible for developing and driving the early medicine strategy for all therapeutic areas by working with strategic alliance partners and collaborations with our Development, Research and CMCC Divisions. This position Leads the Pharmacogenomics (PGx), Pharmacometrics (PMx) and Biomarkers (BMx) functions and directs the early medicine MDs. This position participates in the executive level Development Review Committee and is asked to participate in other cross functional decision making teams where early clinical development is discussed.
- Establish the vision and strategic objectives for early medicine strategy.
- Collaborate with Drug Development Unit (DDU), Therapeutic Area (TA) Development, Global Medical Office (GMO), and CMCC on early medicine strategies for all TAs.
- Develop critical cross-TA strategic alliances and collaborations that support the overall Early Medicine (EM) mission
- Create opportunities for developing key cross-TA research platforms in areas of cellular energetic, inflammasome, the connectome, and overall imaging efforts.
- Lead PGx, BMx, and PMx staff to incorporate broad projects into the EM strategy.
- Build process and continue to be the key stakeholder with Global Clinical Operations to develop unique, lean, cost-effective development paths to conduct work through Proof of Concept (PoC) in less time and cost than current benchmarks, and develop archetypes for lean development.
- Spearhead initiatives with Research to develop key initiatives for Clinical Target Assessment research to reduce uncertainty in the pre-candidate portfolio.
- Ensure CMCC and Tox (along with Development) incorporate new assumptions for delivery of both CTA work and lean-PoC archetypes.
- Serve as Takeda’s representative on external consortia, trade industry working groups, and academic collaborations to continually evolve the field of EM.
- Play a key role in designing and implementing Takeda’s Personalized Medicine strategy across early development.
- Work directly with GMO to establish processes for review and approval of all early phase clinical programs.
Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Educations and Experience
- MD/PhD or MD
- Minimum of 15 years of pharmaceutical industry experience in early clinical design.
- Experienced in lean clinical development
- Knowledge of basic science including emerging areas of cellular energetics, inflammasome and/or next generation sequencing
- 10 years of people management experience
- Superior communication, strategic, interpersonal and negotiating skills
- Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
- Diplomacy and positive influencing abilities across multinational business cultures
- Strong networking skills with experts in academia and industry.
- Ability to lead/facilitate cross-TA clinical discussions
- Experience directing and managing multi-disciplinary groups, including senior leadership members, to accomplish goals.
- Proven experience managing a broad and diverse team
- Ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner in multi-cultural environment.
- Ability to analyze a wide variety of scientific data, financial figures and market data to make strategic decisions.
- Ability to define, develop and implement business solutions based on trends, opportunities, needs and market direction within pharmaceutical industry and health care environment.
- Ability to develop an operating budget to monitor and control expenditures; manages variances between budgeted and actual expenditures of time, dollars, and personnel
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Willingness to travel to various meetings, including overnight trips. International travel is required.
- Requires approximately 30 % travel.
We are driven to improve people's lives.
We are an equal opportunity employer.
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