Associate Director, Clinical Research

Description

The Associate Director, Clinical Research provides clinical project management and leadership to ensure successful operational execution of all US Medical Clinical Research including, Medical Affairs Company Sponsored Studies (MACS) collaborative studies and Investigator Initiated Research (IIR).

Specific objectives include :

Partners with Head of US Medical Clinical Research to translate strategy into efficiently executable research plan; predicting and planning solutions to achieve successful operational execution 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 the design and conduct of MACS, collaborative studies and IIR within assigned TA in accordance with all applicable internal legal and compliance policies as well as external US-specific regulatory guidelines.
• Partners with US Medical TA leadership to determine project prioritization according to TA medical strategy. Proposes resource needs according to study complexity.
• Leads operational planning activities; reports on program progress; manage individual study budgets and communicates status to appropriate TA project manager;

and execute communication and change management plans.

Represents and supports 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. Represents US Medical externally with external collaborators and investigators to develop and ensure execution of research plans, as applicable.

• Identifies and drives 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.

Accountabilities :

Investigator Initiated Research (IIR) Delivery

Defines annual IIR key objectives and KPI’s in partnership with Head, Medical Clinical Research and TA Medical Teams. Provides ongoing reporting on individual studies program progress to inform budget management / invoicing, publications planning, and general progress on TA medical strategy(ies).

Ensures that regular reporting (e.g., key product dashboards, financial aspects) are delivered with high quality and partner with TA Project Managers as necessary.

Oversees & manages external CRO partners accountable to support operational execution of IIR work.

Collaborative Research

Defines annual Collaborative Research key objectives and KPI’s in partnership with Head, US Medical Clinical Research and TA Medical Teams.

Drive and deliver all aspects of clinical trial execution from study concept to final reporting

Research and Operational Excellence

Identifies scalable and consistent reporting methods to transparently inform on key TA or medical products. Provides direction and obtains buy-in from relevant internal stakeholders and team members to therapeutic, functional, or operational strategy.

Identifies ways to accelerate the project execution where possible while maintaining high quality standards. Continuously and efficiently manages 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. Provides clear and targeted messaging to teams, translating corporate priorities into clear and meaningful team goals Identifies ways to accelerate the project execution where possible while maintaining high quality standards.

Manage the planning, operational 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).

Partners with the Head 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.

Drive and 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.

Responsible for building quality relationships with key cross functional stakeholders, that result in valued and trusted partnerships and program support.

Proactively identifies potential issues or obstacles and achieves resolution or plans contingencies and follows issues through to resolution.

Provides 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 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.

Independently resolves complex issues and competing priorities that may impact achievement of goals, and creates mitigation plans and drives to resolution.

Works closely with the US Medical Strategy Team / Medical Unit and / or other cross functional teams, to balance operational execution with Research strategy.

Manages project status reporting and dashboards for a given program, including scheduled as well as ad-hoc updates. Participates 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.

Generates collaboration, cooperation and communication across functions ensuring that team goals are achieved. Provides 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, as well as contractors or CRO service providers.

Orchestrates 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 :

Technical / Functional Expertise

• 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

• Ability to predict issues, anticipate risks and solve problems
• Ability to articulate & establish processes to foster cross-functional efficiency or resource scalability

Interaction

• Flexibility, tolerance and diplomacy to best manage change and differing opinions
• Ability to 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

Innovation

Experience in 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

Complexity

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

Educational, Behavioral Competencies and Skills :

Education

• Bachelor’s Degree science, advanced science degree preferred
• Project Management Professional certification with PMI desired

Knowledge & Experience

Minimum of 8 years of detailed & 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 leading complex pharmaceutical clinical research deliverables in a multi-disciplinary, global or regional environment.
• Experience in 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.
• Minimum of 3 years people management experience.

Leadership Skills & 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
• Fluent in English.

Additional Information :

• Must be able to work at computer for several hours at a time.
• May travel 10% of time, primarily within US with occasional international travel.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location : Lexington, MA

Lexington, MA

U.S. Base Salary Range :

$149,100.00 - $234,300.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and / or from which they will be performing the job.

The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and / or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time