Associate Scientific Director/Scientific Director of Quantitative Clinical Pharmacology応募後で応募 求人ID R0029943 掲載日 06/15/2021 Location:Cambridge, Massachusetts
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Scientific Director/Scientific Director of Quantitative Clinical Pharmacology in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Scientific Director/Scientific Director of Quantitative Clinical Pharmacology working on the team, you will be empowered to manage strategic, scientific and operational aspects of multiple drug development programs from the clinical pharmacology perspective, and a typical day will include:
- Leads strategic, scientific and operational aspects of multiple drug development programs with a high level of technical and strategic independence from first in human dosing through life cycle management. Possesses primary responsibility for dosage selection and generation of causality evidence.
- Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives.
- Explores and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines.
- Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data Sciences Institute (DSI) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications.
- Provides scientific and strategic leadership as the Clinical Pharmacology Lead for multiple programs on Global Program Teams and associated scientific and operational sub-teams.
- Charged with integrating pharmacokinetic, pharmacodynamic, efficacy and safety data from multiple sources to optimize dosing for different populations across the development continuum.
- Responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in collaboration with key partner functions (e.g., SQS, QS and DMPK). Ensures that M&S plans are fully integrated with the larger program development plans to enable impactful Model-Informed Drug Development (MIDD) practices.
- Works closely with colleagues in DSI, QS, and with external partners to ensure advanced modeling and simulation approaches (e.g., QSP, MBMA) 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 for regulatory submissions (such as IB, CTA, CTD Module 2 documents, product labeling).
- Oversees and/or independently performs pharmacometric analyses including the interpretation of PK/PD data in close partnership with DSI and external partners.
- Maintains a high standard for good clinical practice, compliance and ethics.
- Mentors junior staff to promote scientific excellence and individual achievement.
- Represents Clinical Pharmacology in meetings with global regulatory agencies for assigned programs.
- Participates as a member of Business Development due diligence, when requested.
- Leads infrastructure initiatives and/ or cross-functional best practice initiatives.
CORE ELEMENTS RELATED TO THIS ROLE
- This role will be the primary point of accountability in QCP at the asset level for programs that encompass multiple modalities. A high level of technical and strategic independence will be required on the respective Global Program Teams and associated scientific and operational sub-teams.
- Innovative, creative strategies to characterize new modalities through use of emerging technologies related to data generation, alternative study design and analysis will be essential. The QCP team member will be aware of these technologies and use them appropriately.
- Integration of pharmacokinetic, pharmacodynamic, efficacy and safety data from multiple sources to optimize dosing for different populations across the development continuum will be essential. This effort includes integration of physiological and pharmacological knowledge with engineering or mathematical principles to create drug and disease frameworks that will be used for model-informed decision making.
- The individual will be expected to become an acknowledged technical expert, regulatory expert, and thought leader within Takeda who provides strategic scientific leadership, project planning, and decision making from a clinical pharmacology perspective employing a strong enterprise mindset.
- The individual will be on a trajectory as an externally-recognized scientific leader and will build a tangible record of scientific productivity in the field of clinical pharmacology.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Demonstrated hands-on expertise/knowledge 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.
- Able to draft the design and support execution of global clinical pharmacology programs and associated regulatory activities.
- Effective at building alliances across functions.
- Effective interpersonal communication and influence skills, able to drive global collaborations and decisions in a cross-functional, multi-cultural organization.
- Strong oral and written communication skills, including writing, reviewing and editing scientific documents.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Associate Scientific Director Level: Ph.D or Pharm D. w/ 10+ years or M.S. w/ +12 years or B.S. w/ +15 years of pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience.
- Scientific Director Level: Ph.D w/ or Pharm D. w/ 12+ years or M.S. w/ 14+ years or B.S. w/ 16+ years of experience in pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience.
Location and Salary Information:
- This job posting excludes CO applicants.
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
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.