Senior Director, TAK-007 Global Regulatory Affairs Development (GRAD) Strategy Leader

Takeda

  • Boston, MA
  • Permanent
  • Full-time
  • 1 month ago
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that I agree with Takeda’s , and .

Job Description

OBJECTIVES:

The TAK-007 GRAD Strategy Leader will lead the global development regulatory strategy and execution for Takeda’s leading cell therapy project, TAK-007. In close collaboration with the TAK-007 Global Project Leader, Clinical, and other key functions, the GRAD Strategy Leader will:
  • Define, develop, and lead global strategies to maximize global regulatory success towards achievement of program objectives
  • Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of TAK-007, while ensuring compliance with applicable regulatory requirements
  • Act as a leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable
  • Provide leadership and development for direct reports
Furthermore, the role will engage with the broader Regulatory community within Takeda and participate in global initiatives representing Regulatory in support of Takeda R&D objectives.

ACCOUNTABILITIES:
  • Lead the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represent GRT at project team meetings
  • Define strategies and provide tactical guidance to the TAK-007 team and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversee direct reports or junior staff responsible
  • Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
  • Demonstrate ability to anticipate risks, be responsible for developing solutions to identified risks, discuss with team and management, and understand probabilities of technical success for the solutions
  • Be accountable for all US FDA submissions and approvals of TAK-007 or oversee direct reports responsible; lead all submission types
  • Serve as the direct point of contact with health authorities, and lead and manage FDA/health authority interactions/meetings
  • Be accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance
  • Oversee vendor responsibility for regulatory activities and submissions for TAK-007
  • Participate in or lead departmental and cross-functional taskforces and initiatives
  • Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product-specific value evidence topics, as applicable
  • Monitor and anticipate trends that impact both the regulatory and access environments to strengthen TAK-007 development plan(s) and adopt regulatory strategies in a timely manner
  • Be responsible for demonstrating Takeda leadership behaviors
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

Education:
  • Bachelor’s Degree or international equivalent required, advanced degree in a relevant scientific/clinical/regulatory field preferred
Required:
  • 12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience. Oncology and/or cell therapy experience preferred
  • Preferred experience in reviewing, authoring, or managing components of regulatory submissions
  • Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus
  • Ability to understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy
  • Ability to understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy
  • Demonstration of acceptable skills with increasing independence in the area of regulatory strategy, such as understanding broad concepts within regulatory affairs and implications across the organization and globally, proactively identifying regulatory issues, and offering creative solutions and strategies
Knowledge and Skills:
  • Multi-faceted background with direct involvement or experience working with functions from multiple divisions
  • 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
  • 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

Takeda