Translational Sciences Lead - Immunology

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Job Description
OBJECTIVES/PURPOSE

• Plasma-derived therapies (PDT) are critical, life-saving medicines, which patients with rare and complex diseases around the world rely on every day. Global demand for these therapies, particularly immunoglobulins, has increased dramatically over the last 15 years, and continues to grow. Takeda is established as second largest provider of producing plasma-derived therapies (PDT) globally. Leveraging on 75+ year pioneering legacy, Takeda believes there is tremendous potential to do more to meet expectations of patients and health care providers with plasma-derived therapies for patients with immunologic, rheumatologic, hematologic and other complex diseases.
• Within PDT R&D, Nonclinical and Translational Sciences (NTS) Team plays a pivotal role in supporting programs from early development to market authorization by being accountable for innovation and early discovery, non-clinical development, translational & biomarker research and bioanalytical assay development and management to support nonclinical- and clinical-stage programs.

SCOPE

• In NTS Team (NTS), the Translational Sciences Lead - Immunology is responsible for driving new, innovative ideas supporting plasma-derived therapies alone or in combination with other modalities, focusing on preclinical proof-of-concept studies, as well as improvement in understanding disease biology and clinical outcomes. The employee works closely with other members of the NTS team and with Pharmaceutical Sciences team to generate preclinical data package for regulatory filings (IND) and translatable biomarker strategies for patient stratification. In addition, the employee also works closely with various key stakeholder functions (eg. Clinical, Clinical Operations, Medical Affairs, Commercial, Medical Writing) and represents Nonclinical and Translational Sciences function in various global program teams and sub-teams.

Geographic Scope:
Global; with primary responsibilities in Cambridge, MA, US
ACCOUNTABILITIES
The successful candidate will be responsible for performing innovative translational research in the area of immunological, rheumatological and inflammatory diseases.

• Together with the NTS team, responsible for conceptualizing, designing, and managing outsourced research and non-clinical studies at CROs to generate Proof-of-Concept for ongoing and new development programs.
• Independent execution and interpretation of experiments in compliance with appropriate global regulatory guidance.
• Effective and independent management of both internal and external work, including interactions with technical and administrative staff at CROs or external vendors to deliver high quality results in a fast-paced environment.
• Manages or leads projects across the PDT R&D portfolio and schedules activities in accordance with line function and program/corporate goals/assignments and priorities supporting discovery, nonclinical and clinical programs.
• Partners with Clinical, Pharmaceutical Sciences, Computational Biology, Medical Affairs, Commercial, Business Development, and others to ensure that functional deliverables are in line with the program needs
• Represents Nonclinical and Translational Sciences Function in cross-functional meetings
• Participates in design of Biomarker Plans and Immunogenicity Risk Assessments.
• Develops new methods and extends technology to drive applied science into new application areas.
• Implements state-of-the-art technologies to drive applied science into new application areas.
• Provides immunology SME input to cross-functional program teams. Acts as a resource and provides guidance to colleagues.
• Authors or contributes to preclinical study reports and regulatory submission documents
• Authors or contributes to abstracts/manuscripts for publications
• Fosters collaborative work culture within the NTS team and Takeda's culture of Diversity, Equity and Inclusiveness

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)

• Advanced academic degree (PhD or MD/PhD)
• 5+ years of experience in clinical or translational research environment in industry
• Profound understanding of molecular mechanisms of immunity and pathomechanisms thereof - spanning immune tolerance, interaction of adaptive and innate immune response and humoral immunity
• Prior track record in academic research in immunology
• Experience in drug discovery and development of large molecules (biologics), experience with plasma-derived therapies and immunoglobulin therapies is of an advantage.
• Experience with assessments of pharmacokinetics, toxicology and biodistribution studies as well as ADA and biomarker studies in various matrices and tissues (brain, spinal cord, liver, kidney, spleen, lymph nodes) to support both nonclinical and clinical studies is of an advantage.
• Experience in discussing and presenting molecular basis of clinical manifestations, therapeutic approaches and current research paradigms in rheumatology, clinical immunology, hematology, gastrointestinal disorders or hepatic diseases is of an advantage.
• Ability to present complex scientific results in simple terms to a broad audience
• Familiarity and experience with global regulatory guidelines, expectations and corresponding industry best practices (e.g., FDA guidelines, Good Laboratory Practices (GLP))
• Experience in managing external work at CROs.
• Track record of leading and developing employees and team members is of an advantage.
• Being comfortable with working in a fast-paced environment, comfortable with decision-making processes under ambiguity
• Ability to work in matrix organization by collaborating with cross-functional global development teams.

DIMENSIONS AND ASPECTS

• The candidate must be creative, courageous, collaborative, and empowering.
• The NTS team is located in Vienna, Austria, and Cambridge, MA, USA, threfore, ability to define a cohesive culture based on Takeda's values is essential.
• Expect travel time: 10%

Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)

• Ability to identify potential challenges and opportunities and make recommendations
• Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company
• Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and modeling these behaviors for the organization
• Invests in helping others learn and succeed
• Able to influence without authority at senior (TET-2/TET-3) level

Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)

• Accountable for acting decisively and exercise sound judgment in making decisions
• Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence
• Ability to seek diverse input by balancing multiple internal and external multiple stakeholders to drive solutions and set priorities
• Ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution
• Develops executable plans and meets budget and deadlines
• Builds a culture of data driven decisions

Interaction (The span and nature of one's engagement with others when performing one's job, internal and external relationships)

• Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions
• Skilled communicator, able to persuasively convey ideas verbally and in writing

Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk-taking)

• Disruptive thinker with the ability to influence and change how PDT uses data to make decisions and sets priorities
• Ability to identify areas for innovation and implement change that will enhance the overall effectiveness of the team.

Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)

• Recommends key decisions and escalates key issues per agreed governance framework
• Creates clarity of accountabilities in a global and highly matrixed organization
• Ability to provide data that will resolve or simplify complexity
• Resilient and comfortable working through large scale global change management

Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MA
U.S. Base Salary Range:
$153,600.00 - $241,340.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
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.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.