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Associate Director, Clinical Operations Program Lead (COPL), Cell Therapy

Bio-Life Plasma, LLC

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Boston, MA
LOCATION
Third Shift
SHIFT

Job Description

As posted by the hiring company

Job Overview:

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?

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:

  • Provide operational expertise and strategic input to the development of Clinical Development Plans (CDP) supporting the overall clinical strategy for one or more cell therapy clinical programs, which may include highly complex, high-risk, and/or high-priority programs.
  • Develop and lead the program-level operational strategy and planning on assigned programs in close collaboration with our strategic partners and other vendors.
  • Provide program-level sponsor’s operational oversight of our strategic partners and other vendors to ensure the effective execution of the clinical studies on time, with high quality and within agreed budget.
  • Represent Clinical Operations at the Global Program Team (GPT) and partner with Global Clinical Lead to lead the Clinical Sub Team (CST) accountable for the development and execution of the CDP.
  • Take on functional leadership responsibilities, which may include line management, providing expert consult for issue resolution and assisting the Head of Cell Therapy Clinical Operations
  • Responsible for strategic cross-functional initiatives for process and/or business improvements

ACCOUNTABILITIES:

  • Accountable to the GPT for the translation of the CDP into an optimal operational strategy and plan. Ensures assessment of various scenarios operational for optimal execution of the CDP.
  • Partner with the CST to develop high quality study synopsis/protocol by providing operational input and by ensuring all relevant stakeholders (both internal and external) are involved and contributing.
  • Maintain close communication with the Global Program Leader to ensure expectations and activities are aligned.
  • Develop and lead the clinical program operational strategy and planning on assigned clinical programs in close collaboration with the Clinical Operations Managers (COMs), our strategic partners, other CROs, other vendors, and with the CST.
  • Perform program-level oversight of our strategic partners and other vendors to ensure the overall operational execution and delivery of the assigned clinical programs in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
  • Collaborate with COMs and cross-functional counterparts to oversee the performance for all activities assigned to our strategic partners/other CROs/other vendors, including escalation of issues to governance committees and to senior management when warranted.
  • Responsible for clinical program budget planning and accountable for external spend related to clinical program execution. Works closely with COMs, Global Program Management (GPM), Outsourcing Management, and Finance to ensure on a regular basis that budgets, enrolment, and gaiting are accurate.
  • Communicates program status, cost and issues to ensure timely decision-making by senior management.
  • Provide program-level direction, guidance and support to the COM in the development of study strategy operational plans including enrolment models and risk management strategy.
  • Serve as the point of escalation for the COMs for issues that can’t be resolved at the study level.
  • May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence.
  • Review and provide expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis & protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), updates to IND and NDA documents, DSURs and other safety reports; Provide expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2, Request for Scientific Advice Meetings, etc.), as appropriate.
  • Collaborate with COMs, Strategic Partners/other CROs/other vendors to ensure inspection readiness.
  • Leads Clinical Operations aspects of inspection readiness activities and acts as subject matter expert during regulatory inspections
  • Lead cross-functional strategic initiatives and process improvement.
  • Actively seek new ways of working more efficiently to meet the needs of clinical development.
  • Act as a role model for Takeda´s values
  • May become a line manager for Clinical Operations staff
  • Recognized as a clinical operations expert by other functions and stakeholders across R&D
  • Help with onboarding and mentoring of COMs and Senior Manager COPLs
  • May assist the Head of Cell Therapy Clinical Operations function, as required.
  • For certain types of studies and programs, COPL may have the following responsibilities:
    • Is a key point of contact between the strategic partners/preferred supplies and the GPT/CST.
    • Provide program & study-level direction and support to the strategic partners/preferred suppliers for the development of study strategy operational plans including enrolment models and risk management strategy.
    • Performs site feasibility/capability assessments for programs/studies requiring specialized experimental tests and/or technologies and work with internal experts and sites to ensure successful operational outcomes
    • Work with Procurement, QA & Legal to qualify new clinical vendors and, when appropriate, manage vendors for duration of a study (for vendors contracted directly with Takeda)

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

Education:

Bachelor’s degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable.

Skills:

  • Demonstrated excellence in program management, including scenario assessment, risk assessment and contingency planning
  • Demonstrated excellent matrix leadership and communication skills
  • Able to influence without authority
  • Excellent teamwork, communication, organizational, interpersonal, conflict resolution and problem-solving skills
  • Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo
  • Pragmatic and willing to drive and support change
  • Is comfortable with ambiguity
  • Embody a culture of continual improvement and innovation; promote knowledge sharing
  • Fluent business English (oral and written)

Experience

10+ years’ experience in pharmaceutical industry and/or clinical research organization, including 7+ years clinical study/project management. Experience must include cell therapy early phase clinical studies/Phase 2 studies or later phase global/international programs. Experience in more than one therapeutic area is highly desired. Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.

TRAVEL REQUIREMENTS:

  • Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.

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.

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

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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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