Head of Global Clinical Science, Marketed Products Group
Found in: Lensa US
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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? Join us as Head of Global Clinical Science, Marketed Products Group 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 Objectives:
Accountable for the global clinical and medical strategic oversight for marketed products within the R&D Marketed Products Group portfolio, a large and diverse global portfolio covering all core and non-core therapeutic areas, global, and established brands Accountable for the scientific and clinical expertise to support marketed product activities for products within the R&D Marketed Products Group portfolio Provides global leadership of the MPG Clinical Science group ensuring medical oversight and robust clinical scientific input at Global Program Teams (GPTs) and Product Support Teams (PSTs) and rapid and effective resolution of strategic or scientific issues to meet company milestones.Oversees benefit risk assessments, clinical development plans, and clinical components of regulatory submissions for the Marketed Products Group portfolio Collaborate with TAU Heads of Clinical Science to plan GPT transition from TAU to MPG ensuring robust transfer of clinical science knowledge and activities Accountabilities:
Accountable for the global clinical and medical strategic oversight for marketed products within the R&D Marketed Products Group portfolio Leads the Global Clinical Science group physician/scientist team ensuring medical oversight and provision of scientific and clinical inputs to GPTs and PSTs collaborating with Global Project Management, Global Patient safety Evaluation (GPSE), Regulatory Affairs, Statistics, Clinical Operations, Medical Affairs, and commercial stakeholders.
Represents Clinical Science on the Marketed Products Group Leadership Team as well as the joint leadership team with the Marketed Brands Unit (GPLS) to providing support, guidance and advice to GPTs Ensure rapid and effective resolution of strategic or scientific issues for marketed products to meet company milestones.
Oversees benefit risk assessments, clinical regulatory submissions and clinical development plans, ensuring continued accessibility of Takeda's on-market medicines to patients Collaborates with GPSE and Quality functions to ensure safety and quality matters are appropriately addressed and resolved in a timely manner through thorough assessments Collaborate with, and provide input to, Medical Affairs activities for LCM, country level strategies and provides input to Medical Affairs Phase IIIb / IV studies and local protocols Accountable for delivery of geographic expansion clinical development strategy which include key aspects of Target Product Profiles (TPPs) required for successful development, continued commercialization, pricing, and reimbursement.
Lead Clinical Science evaluations for post-marketing licensing candidates through nomination and oversight of staff for technical due diligence and coordination for development input and recommendations.
Lead the global MPG Clinical Science organization in terms of process management, resource allocation, efficiency and standards, ensuring equitable regional utilization of resources Hiring, retaining and developing talented physicians and scientists who will be accountable for medical oversight or participation in the designs of clinical drug development plans and for the execution of such plans for their therapeutic area and global prioritization and tradeoffs.
Working with clinical operations and global product teams, ensure excellent execution of integrated drug development programs across multiple therapeutic areas, including ensuring appropriate budget and schedule planning are obtained to meet project needs.Provide ad hoc input and collaboration with (internal and external) and cross-functional strategic teams and task forces.
Represent Clinical Science at the global team level, providing overall clinical development /local regulatory submission experience and leadership where required.Represent the Marketed Products Group in Sr. Level Scientific governance meetings (i.e. Safety Review Board, Global Labeling Oversight Committee (GLOC). Liaises with Therapeutic Area Unit (TAU)
Heads of Clinical Science to facilitate planning and smooth transition of clinical science activities from TAU to MPG CORE ELEMENTS RELATED TO THIS ROLE Develop and maintain sufficient working familiarity with the scientific and medical aspects for oversight of all therapeutic areas in order to provide scientific and strategic guidance, mentoring and leadership across these areas.
Ensure in liaison with Quantitative Science groups as well as clinical modeling teams as to the strategy and the integrity and correctness of analysis, interpretation and appropriate integration of safety and efficacy data from development programs and clinical studies longitudinally and cross-sectionally in support of regulatory submissions across all therapeutic areas, ensuring data quality and adherence to national and international regulations and requirements and ICH.
DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Comprehensive understanding of the pharmaceutical industry and industry and specifically, clinical development and post-marketing commitment and requirements globally Leadership Embraces and demonstrates a diversity, equity and inclusion mindset and role models these behaviors for the organization Engaged and inspiring people manager who invests time in supporting their employees Demonstrated ability to work across functions, regions and cultures Functional level leadership with the ability to inspire, motivate and drive results Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing Proven skills as an effective team player who can engender credibility and confidence within and outside the company Ability to distil complex issues and ideas down to simple comprehensible terms Demonstrates leadership presence and confidence Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives.As a role model leader, Invests time in helping others to enhance their skills and perform at a higher level across the organization Decision-making and Autonomy Decision making responsibilities:
Provide input to highly complex decisions that impact the functional area Accountable for decision making for designated function Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution Accountable for providing input to and implementing vision and strategy for designated scope Interaction Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions Innovation Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation Comfortable challenging the status quo and bringing forward innovative solutions Ability to take risks implementing innovative solutions, accelerating time to market Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.Role models respect and inclusion, creating a culture that fosters innovation Complexity Ability to work in a global ecosystem (internal and external) with a high degree of complexity Deep expertise required Ability to see and understand broader, enterprise level perspective EDUCATION,
BEHAVIOURAL COMPETENCIES AND SKILLS:
MD required; Ph.
D or advanced degree desired Advanced scientific training/experience in the pharmaceutical industry or a related field Direct experience in the pharmaceutical industry or related field required Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams.Strong judge of talent with the ability to make tough talent decisions.
Health care business acumen with a comprehensive understanding of the pharmaceutical industry Effective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda.
As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles.
US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines.
Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.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 Empowering Our People to Shine This job posting excludes CO applicants. Discover more at No Phone Calls or Recruiters Please. LI-CS1 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
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