Senior Scientific Director/Scientific Director, Quantitative

Company: Takeda Pharmaceuticals International GmbH
Location: Boston
Posted on: January 15, 2021

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the Coronavirus (COVID-19), we're leveraging our digital capabilities to ensure we can continue to recruit top talent at Takeda. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our colleagues will explain how these tools will be used during the recruitment process. Thank you. *Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers. See below or here for more info. Senior Scientific Director/Scientific Director, Quantitative Clinical Pharmacology Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda's long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole. As one of the world's leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units. We are a passionate team doing important work that impacts patients' lives. If you are driven to create better health and a brighter future, join us! Success What makes a successful member of our team? Check out the traits we're looking for and see if you have the right mix. Life at Takeda A Global Top Employer Recognized for our culture and way of working, we're one of only select companies to receive Top Global Employer -- status for 2020. Senior Scientific Director/Scientific Director, Quantitative Clinical Pharmacology Job ID R0019346 Date posted 05/04/2020 Location Boston, Massachusetts Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Scientific Director/Scientific Director, Quantitative Clinical Pharmacology in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. OBJECTIVES/PURPOSE

• The Senior Scientific Director/Scientific Director manages strategic, scientific and operational aspects of multiple drug development programs from the clinical pharmacology perspective with a high level of technical and strategic independence.
• Serves as the Global Clinical Pharmacology Lead for assets across phases 1-4 of development with a high level of technical and strategic independence. Works closely with functional experts across the R&D organization, such QS, Research, Biostatistics, Regulatory Affairs, DMPK, Pharm Sci, and Clinical Science providing leadership and guidance in clinical pharmacology activities.
• Contributes to departmental management through program reviews and collaborative decision-making, and leads infrastructure / best practice initiatives.
• Supervises and mentors junior staff providing professional and career development. ACCOUNTABILITIES
  • Provides scientific and strategic leadership as the Clinical Pharmacology Lead for multiple programs on Global Program Teams and associated scientific and operational sub-teams.
  • Responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in collaboration with key partner functions (e.g., QS and DMPK). Ensures that M&S plans are fully integrated with the overall clinical pharmacology plans to enable Model-Informed Drug Development (MIDD).
  • Works closely with colleagues in QS to ensure strategic integration of advanced modeling and simulation approaches (e.g., QSP, MBMA) across the development continuum to inform internal decisions and external regulatory interactions.
  • Creates or assists in the preparation of protocol synopses, oversees program execution including protocol conduct, data analysis and reporting.
  • Responsible for clinical pharmacology summary documents (such as IB, CTA, CTD Module 2 documents, product labeling).
  • Oversee and/or independently perform PK/PD analyses including the interpretation of PK/PD data and associated statistical analyses in close partnership with external CRO partners.
  • Maintains a high standard for good clinical practice, compliance and ethics.
  • Mentors junior staff to ensure they value scientific excellence.
  • Represents Clinical Pharmacology in meetings with global regulatory agencies for his/her assigned programs.
  • Participates as a member of Business Development due diligence, when required.
  • Leads infrastructure initiatives and/ or cross-functional best practice initiatives. CORE ELEMENTS RELATED TO THIS ROLE
    • This role will be expected to be the primary point of accountability in QCP at the asset level for high complexity programs across multiple therapeutic modalities with a high level of technical and strategic independence as the Clinical Pharmacology Lead on the respective Global Program Teams and associated scientific and operational sub-teams.
    • Senior Scientific Director, QCP has extensive experience and is an acknowledged technical expert and thought leader within Takeda who provides strategic scientific leadership, project planning, and decision making from a clinical pharmacology perspective with a strong enterprise mindset. S/he will thus be expected to lead infrastructure and/ or best practice initiatives.
    • Externally recognized for scientific leadership in quantitative clinical pharmacology demonstrating a sustained record of scientific productivity in the field of clinical pharmacology, as evidenced by the development and/or implementation of numerous new technical strategies, methods, processes and publications. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise
      • Demonstrated expertise in application of PK/PD, modeling and simulation, and use of clinical biomarkers for decision making.
      • Demonstrated scientific and technical expertise through publications, patents, awards/honors or credibility at professional societies. Strong knowledge of allied fields critical for drug development, such as drug metabolism, pharmacology, toxicology, bioanalytical chemistry, and pharmaceutical science.
      • Demonstrated experience with design and analysis of clinical pharmacology studies. Leadership
        • Demonstrated experience with design and execution of global clinical pharmacology programs and associated regulatory activities.
        • Effective at building alliances across functions.
        • Excellent interpersonal communication skills, able to drive global collaborations in cross-functional, multi-cultural organizations.
        • Excellent oral and written communication skills, including writing, reviewing and editing scientific documents.
        • Ability to effectively influence colleagues and multi-disciplinary project teams. Decision-making and Autonomy
          • High level of technical and strategic independence in driving all clinical pharmacology aspects of program strategy and associated trial designs, analysis plans and regulatory documentation, and interpretation and communication of results.
          • Accountable for planning, budgeting/ resourcing and prioritization decisions related to all QCP deliverables for programs in the assigned section of the portfolio.
          • Serves as the sole representative of QCP both internally at GPT/ CST meetings and externally at worldwide meetings with regulatory agencies and Advisory Board Meetings. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
            • Ph.D or Pharm D. w/ +10-15 years or M.S. w/ +15-20 years or B.S. w/ +20-25 years of pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience. WHAT TAKEDA CAN OFFER YOU:
              • 401(k) with company match and Annual Retirement Contribution Plan
              • Tuition reimbursement Company match of charitable contributions
              • Health & Wellness programs including onsite flu shots and health screenings
              • Generous time off for vacation and the option to purchase additional vacation days Check out where you could be
                working if you apply. Job Seekers: Protect yourself against identity theft Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers. Copyright 1995-2019 Takeda Pharmaceutical Company Limited. All rights reserved.

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