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Senior Director Clinical Operations, CAR-NK TAK-007

Boston, Massachusetts

Overview

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!

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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

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  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

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Senior Director Clinical Operations, CAR-NK TAK-007

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Job ID R0023270 Date posted 09/22/2020 Location Boston, Massachusetts

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Job Description

The Clinical Operations Leader is fully-dedicated and responsible for the overarching CAR-NK platform and TAK-007 clinical operations strategy, its execution, and management of the clinical programs, supporting the clinical strategy as defined in the Clinical Development Plan (CDP). Key activities include strategy and planning towards milestones, managing the supporting clinical operations team, managing external vendors and critical path activities, proactively identifying issues, resolving conflicts, and communicating project-related challenges / issues to the Global Project Leader. Additionally, the TAK-007 Clinical Operations Leader will be responsible for financial planning / forecasting and budget management for the TAK-007 clinical operations strategy, as well as for administrative budget oversight for direct and indirect reports. The TAK-007 Clinical Operations Leader will represent Global Clinical Development Operations as the primary point of contact across the Global Project Team, the Oncology Therapeutic Area Unit, other internal stakeholders, and vendors. The Leader will work closely with key functions within the Global Project Team (e.g., Clinical, Translational, Biostats, Data Integration) and external vendors to ensure that project deliverables, timelines, and budget are met to maximize value and to realize Takeda’s overall vision. Furthermore, the TAK-007 Clinical Operations Leader will engage with the broader Clinical Development Operations community within Takeda and participate in global initiatives representing Clinical Development Operations in support of Takeda R&D objectives. This role will build and lead a team of clinal development functions initially including clinical trial manages, site engagement catalyst, data management and other roles to build capabilities for exceptional operational execution.

ACCOUNTABILITIES: 

  • Reporting to the Global Project Leader, works collaboratively as a Core Global Team Member to partner with Global Clinical Lead and other key functions within the Global Project Team, including key internal stakeholders to define operational strategy for TAK-007, our first CAR-NK platform therapy.

  • Oversees and directs CRO deliverables as per the Global Development Strategy

  • Maintains responsibility for on-time, on-budget delivery of clinical development plan

  • Ensures clinical operations process and work product is compliant with global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP

  • Oversees clinical budget planning / forecasting and management for TAK-007

  • Directly manages clinical operations staff

  • Works closely with vendors and directly oversees critical path activities to ensure adherence to timelines

  • Proactively identifies project risks before they arise and develops contingency plans; escalates issues related to quality, timelines, and budget and provides recommendations to upper management for resolution

  • Optimizes our cell therapy Clinical Operations organization to impact speed, quality and costs.

  • Builds highly effective external cell therapy network of contributing sites to deliver on plan

  • Contributes to the creation and maintenance of systems / processes for the purpose of reviewing database progress in real time, ensuring timely resolution of outstanding queries and database cleaning, and applying data analytics to large data sets

  • Leads and/or participates in initiatives for process, technology, or other continuous improvement to achieve cost-reduction, time-savings, efficiency, quality and/or other business objectives

  • Maintains current cell therapy landscape knowledge and continually assesses impact of new and evolving information on operational strategies

  • Maintains responsibility for functional leadership in global clinical operations for TAK-007, including both direct line management (hiring, training, staff assignments, coaching, mentoring, and performance management) and indirect management of global clinical operations staff in a matrix environment

  • Acts as a role model for Takeda’s values

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

Required:

  • Bachelors Degree or international equivalent

  • At least 15 years of clinical study / program management experience in the pharmaceutical industry, including at least 6 years of line management experience

  • Proven track record of leadership and project management success at the director level

  • Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP

  • Global / International experience, including ability to manage intercultural regionally-based teams and fluent business English skills (oral and written)

  • Experience in successful change management (strategy, initiation, development and implementation of important, organization wide changes)

  • Previous line management or direct management of team members

Preferred:

  • Bachelors Degree or international equivalent in the Life Sciences; advanced degree highly preferred

  • Experience in cell therapy and/or oncology highly preferred

  • Broad business orientation highly preferred

  • Experience with project leadership and management systems and methodology

  • Multi-faceted background with direct involvement or experience working with functions from multiple divisions

  • Must have an understanding of and experience with worldwide Regulatory submissions and approval processes

  • Expert knowledge in the overall pharmaceutical drug development process

  • Demonstrated ability to build consensus and drive resolution of issues while maintaining positive working relationships across functions; negotiation and strong persuasive abilities

  • Strong written and verbal Communication Skills: ability to express oneself clearly and concisely to external partners, vendors or with others within the team; ability to message key issues appropriately and document issues and/or concerns concisely and comprehensively; ability to adjust language and/or terminology appropriate for the audience; demonstrated ability to clearly and concisely communicate / present key information to senior management

  • Analytical and Problem Solving Skills: ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem

  • Strategic Implementation: ability to develop, implement and monitor the overall clinical operations strategy

  • Leadership Skills: develops and uses knowledge and interpersonal skills to influence and guide others towards the accomplishment of Takeda’s goals and objectives; requires the flexibility and tolerance to best manage change and differing opinions with diplomacy and competence

  • Ability to drive decision-making within a cross-functional, cross-divisional and cross-cultural, global team structure and requires global mindset and cultural awareness in working with senior leadership in other regions and in managing cross-regional projects

  • Knowledgeable in the processes for managing and developing personnel in a cross-functional, matrix-team, global environment with a proven track record

  • Knowledgeable in budget and finance processes appropriate to the pharmaceutical industry

  • Ability to adapt to other personalities in a respectful manner that is conducive to goal achievement

  • Ability to capture knowledge within the cross-functional, cross-divisional global organization; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use

  • Management of multiple tasks of varied complexity simultaneously

  • Ability to work in a demanding environment with aggressive project timelines

TRAVEL REQUIREMENTS:

  • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required

  • Requires approximately 20-25% travel

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0023270

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