About the role:
Join Takeda as an Associate Director, US Medical Clinical Research where you will provide clinical research leadership to ensure successful strategic implementation of all US Medical Clinical Research including, Medical Affairs Company Sponsored Studies (MACS) and collaborative studies. As part of the US Medical team, you will report to the Head, US Medical Clinical Research. This is a hybrid role based in Lexington, MA.
How you will contribute:
• Partner with Head of US Medical and Director of Clinical Research to translate strategy into efficiently executable research plan; predicting and planning solutions to achieve successful strategic implementation to meet study objectives and strategic objectives; driving the team to achieve clarity on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making, monitoring slippage and developing strategies to get back on plan and navigating through the internal governance for projects.
• Responsible for design feasibility, oversight and conduct of MACS, and collaborative studies within assigned TA in accordance with all applicable internal legal and compliance policies as well as external US-specific regulatory guidelines.
• Partner with US Medical TA leadership to determine project prioritization according to TA medical strategy. Propose resource needs according to study complexity. Leads strategic implementation planning activities; reports on program progress; manage individual study budgets and communicates status to appropriate TA project manager, Scientific and Medical Directors; and assists in executing communication and change management plans.
• Represent and support US Medical Clinical Research including synopsis and protocol development with all relevant stakeholders. Oversee reporting of study and/or program progress; ensure appropriate invoicing/budget management. Represent US Medical externally with external collaborators and investigators to develop and ensure execution of research plans, as applicable.
• Identify and drive innovative process improvements with significant organizational impact and takes on, as needed, non-project responsibilities, which can include project management processes and systems.
• Lead and matrix-manage high performing study teams, collaborating across the organization.
Research and Strategic Implementation Excellence
• Define annual Research KPI's in partnership with Head, and Director of Medical Clinical Research and TA Medical Teams.
• Provide ongoing reporting on individual studies program progress to inform budget management/invoicing, publications planning, and general progress on TA medical strategy(ies).
• Ensure that regular reporting (e.g., key product dashboards, financial aspects) are delivered with high quality and partner with TA Project Managers as necessary.
• Manage external CRO partners accountable to support operational execution of IIR work.
• Deliver all aspects of clinical trial execution from study concept to final reporting
• Identify scalable and consistent reporting methods to transparently inform on key TA or medical products.
• Provide direction and obtain buy-in from relevant internal stakeholders and team members to therapeutic, functional, or operational strategy.
• Identify ways to accelerate the project execution where possible while maintaining high quality standards.
• Efficiently manage stakeholders at various levels, across all US Medical functions.
• Addresses and resolves project challenges, keeping leadership informed of critical considerations (e.g., resources, performance concerns). Provides clarity and direction in urgent or unexpected situations.
• Provide clear and targeted messaging to teams, translating corporate priorities into clear and meaningful team goals
• Manage the planning, implementation, and reporting logistics of the Research and/or other teams (including but not limited to; meeting schedule management, meeting facilitation, development of meeting materials with contributors, capture and follow up of action items and deliverables, distribution of minutes, and maintenance of relevant SharePoint site (or equivalent).
• Partner with the Director of US Medical Clinical Research to lead and manage Research Team meeting, or other teams, through the project plan execution and holds to the highest standards for operational excellence and compliance in all US Medical activities.
• Deliver all aspects of clinical study execution from study concept to final reporting, coordinate and ensure team deliverables for project completion for assigned research activities across all functions.
• Build quality relationships with key cross functional stakeholders, that result in valued and trusted partnerships and program support.
• Identify potential issues or obstacles and achieves resolution or plans contingencies and follows issues through to resolution.
• Provide financial oversight for program/study budgets. Includes consolidation, vetting and prioritization of spending risks and opportunities, in partnership with Head of US Medical Clinical Research and Director of Research, in collaboration with US MA Medical and Scientific Leads.
• Leads the project risk management process and generates the cross-functional project risk register for assigned projects. Ensure that the risks identified for US Medical activities are reported up through to the Program Manager and Medical and Scientific Leadership.
• Independently resolve complex issues and competing priorities that may impact achievement of goals, and creates mitigation plans and drives to resolution.
• Work with the US Medical Strategy Team/Medical Unit and/or other cross functional teams, to balance study implementation and execution with Research strategy.
• Manage project status reporting and dashboards for a given program, including scheduled as well as ad-hoc updates.
• Participate in regular project portfolio reviews at the Medical Franchise Unit for a given TA to ensure accurate information, timelines and budgets are completed to support project recommendations to Senior Management.
• Generate collaboration, cooperation and communication across functions ensuring that team goals are achieved.
• Provide direction, mentors junior colleagues, as applicable, looks for opportunities for junior staff to demonstrate their abilities; uses effective coaching techniques; leads by example. May have responsibility for line management of Senior Managers, and contractors or CRO service providers.
• Orchestrate the involvement of appropriate cross-regional or cross-functional stakeholders in relevant communications, decisions and working group.
• Establish best practices and embrace an open, learning, sharing culture.
• Implement novel trial designs, including digital interventions, as applicable.
DIMENSIONS AND ASPECTS
• Comprehensive understanding of the pharmaceutical industry and regulations governing medical functions within industry activities and medical regulatory process, including clinical research, study design, and good clinical practice.
• Strong clinical research and program management experienced in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory, CMC or other drug development related function.
• Experience managing study budgets across multiple Therapeutic Areas
• Applied knowledge of performance management (e.g., metrics, dashboards)
Decision-making and Autonomy
• Predict issues, anticipate risks and solve problems
• Ability to articulate and establish processes to foster cross-functional efficiency or resource scalability
• Flexibility, tolerance and diplomacy to best manage change and differing opinions
• Work in a highly complex, multi-cultural, often stressful environment
• Highly effective communications skills – written and verbal
• Demonstrated ability to concisely communicate/prepare presentations for management
• Excellent organizational skills
• Effective negotiation and positive influencing abilities
• Proven ability to work effectively and diplomatically in conflict situations
• Experience identifying and driving opportunities for process improvements with significant organizational impact and takes on, as needed, non-project responsibilities, which can include project management to implement new processes and systems
Management of multiple tasks of varied complexity to enable successful delivery of multiple and/or complex projects within a single or across therapeutic areas for US Medical
• Bachelor's Degree science, advanced science degree preferred
• Project Management Professional certification with PMI desired
Knowledge & Experience
• Minimum of 8 years of detailed and in-depth pharmaceutical industry experience and drug development in all phases of development with significant experience within related functions (e.g., Medical Affairs, Clinical Operations, Regulatory, CMC, Marketing).
• Minimum of 5 years' experience as a clinical project/program manager or clinical science leading complex pharmaceutical clinical research deliverables in a multi-disciplinary, global or regional environment.
• Experience leading global or regional cross-functional teams spanning drug development life cycle with emphasis on late-phase (i.e., Ph 3-4) and post-marketing development (e.g., thru Patent Exclusivity expiration).
• Thorough understanding of legal, compliance, and regulatory guidelines related to the conduct of a variety of types of research trials in the pharmaceutical industry.
• Knowledge of pertinent external guidelines related to research and publications, and current standards of practice.
• People management experience preferred
Leadership Skills and Behaviors
• Matrix project leadership and proven line management skills are required.
• Proven strategic problem-solving ability and identify appropriate solutions.
• Solid influencing skills and ability to negotiate in a matrix environment to optimize development and address barriers.
• Highly effective written and verbal communication skills, including strong presentation skills.
• Ability to lead business process transformation and implement organizational culture change.
• Simultaneous management of multiple tasks of varied complexity.
• Flexibility, tolerance and diplomacy to best manage change and differing opinions.
• Excellent organizational skills.
• Proven skills in negotiation, influencing without authority, managing through ambiguity, and working diplomatically through conflict.
• Sufficient knowledge of all MS Office tools to effectively capture and communicate project information
• May travel ~10% of time, primarily within US with occasional international travel.
What Takeda can offer you:
• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• 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 and company match of charitable contributions
• Family Planning Support
• Flexible Ways of Working
• Tuition reimbursement
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
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
Lexington, MAWorker Type