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Clinical Pharmacology Lead - Cell Therapies

Company: Takeda Pharmaceuticals International GmbH
Location: Cambridge
Posted on: February 20, 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. Clinical Pharmacology Lead - Cell Therapies 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. Clinical Pharmacology Lead - Cell Therapies Job ID R0025311 Date posted 12/10/2020 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 Clinical Pharmacology Lead - Cell Therapy 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.

As a Clinical Pharmacology Lead for Cell Therapies, you will support the development of these novel therapeutic modalities from early phase to late phase and regulatory submission. You will also be charged with characterization and integration of knowledge related to the kinetics of human cellular distribution, expansion, persistence, and measures related to efficacy and safety. You will be responsible for supporting dose level and regimen recommendations, identification of genetic and demographic factors that impact efficacy and safety, and other clinical and regulatory support for Takeda's cell therapy programs. You will develop clinical pharmacology strategies, execute clinical pharmacology studies, and perform dose-exposure-response analyses within the context of multi-scale, physiologic systems in the cell therapy context. The position's objectives also include comprehensive understanding and interpretation of preclinical packages, protocol development, data interpretation, study report completion, and communication of results with recommendations on future development decisions.

This position will report to Head of Cell Therapy Clinical Pharmacology & Modeling, with 100% of efforts devoted to cell therapy development. All efforts will be directed toward progression of cell therapies into and through clinical development with the ultimate objective of global regulatory approval. ACCOUNTABILITIES: This role will be expected to be the primary point of accountability at the asset level for assigned programs and will provide scientific, and quantitative input as the Clinical Pharmacology Lead on the Global Program Teams, and associated scientific and operational sub-teams. Responsible for the design and implementation of the Clinical Pharmacology plans using traditional and model informed drug development approaches and will manage the clinical study process from protocol development to final study reporting. L eads dose justification, reinfusion strategy, CKPD based assessments, immunogenicity by integrating cellular kinetics, pharmacodynamics, product and patient characteristics throughout clinical development in close collaboration with key functions. Conduct or oversee non-compartmental analysis (NCA), cellular kinetic (CK)/pharmacodynamic (PD) and dose-exposure-response analyses to support dose selection and trial design at all stages of drug development, internal go/no decision-making, regulatory submission documents, and publications. Responsible for clinical pharmacology contributions to all regulatory documents including Investigator Brochures, protocols, pre IND, EOP1/2 and BLA meetings. Takes a lead role in writing and reviewing responses to pharmacology queries from regulatory agencies. During the pre-clinical stages of product development works with research teams to ensure quantitative mechanistic understanding and preclinical PK-PD knowledge to justify human dose and route of administration. Provide input to optimize in vitro & preclinical CKPD data supporting the dose & advancement of programs into clinical development and the submission of Investigational New Drug applications. Accountable for ensuring that there are valid methods for measuring cellular kinetics and immunogenicity in the clinic. Manage program timelines for clinical pharmacology components and related matters; manage budgets to meet or exceed time, quality, and fiscal objectives. Assure cross-functional alignment for Clinical Pharmacology activities with other functional areas involved in clinical development programs, within Takeda, intercompany interfaces, and partnerships. Initiate and manage external collaborations with leaders in clinical development and Key Opinion Leaders. Mentors and coaches junior staff, promoting Takeda's values and behaviors EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: Education: PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Engineering or other disciplines related to quantitative pharmacology Required: Minimum of 8 years of clinical pharmacology/modeling experience in the pharmaceutical/ biotechnology industry covering early to late phase clinical development Experience with and/or strong interest in Cell Therapy, Oncology or Immunooncology Ability to apply pharmacokinetic and pharmacokinetic-pharmacodynamic concepts, including modeling and simulation to clinical trial design, and address clinical & product related questions. . Demonstrated expertise in the design, analysis and reporting of clinical pharmacology studies. The candidate must be competent in the use of industry-standard computational software for noncompartmental, physiological and multi-scale modeling, and Bayesian analyses and simulation. Track record of publications and contributions to INDs, NDAs/BLAs, with various regulatory agencies & defending clinical pharmacology packages. Strong technical proficiency in pharmacokinetic software (e.g WinNonlin, NONMEM, Monolix, R, etc.) and modeling. Ability in managing multiple programs Knowledge and Skills: Excellent written and verbal communication, organizational and interpersonal skills, be a strong team player and fully at ease in a matrix environment. Ability to advance multiple projects in a fast paced "biotech like" environment; drive initiatives, lessons learned, and best practices Ability to work in a demanding environment with aggressive project timelines Demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. TRAVEL REQUIREMENTS: Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required Requires approximately 10% travel 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.

Keywords: Takeda Pharmaceuticals International GmbH, Cambridge , Clinical Pharmacology Lead - Cell Therapies, Healthcare , Cambridge, Massachusetts

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