Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Clinical Program Director in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Clinical Program Director working on the Clinical Operations team, you will be empowered to contribute to the Clinical Development Plan and associated operational strategy, in support of the Gastrointestinal asset strategy and a typical day will include:
You will lead and direct the execution of clinical program(s) within our Gastrointestinal (GI) Therapeutic area
Provide Clinical Operations leadership under the direction of the Global TA Clinical Operations Lead:
- Lead and manage multiple clinical programs within the TA through the direct supervision of Clinical Program Managers.
- Accountable for the execution of assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
- Accountable for the oversight of Strategic Partners and other vendors to meet Takeda s obligations described in ICH-GCP and Takeda s business objectives.
The assigned clinical program(s) will be large, complex, high risk and/or of business importance to Takeda, requiring multi-functional leadership experience and skills to achieve program goals. If a single program is assigned, the program will typically be significant in scope (e.g., multiple independent indications with individual Clinical Sub-teams). The Director of Clinical Program Management will also take on functional leadership responsibilities including mentoring and training less experienced Clinical Program Managers, providing expert consult for issue resolution, and assisting the Global TA Clinical Operations Lead.
- Oversee the overall execution of the assigned clinical program(s) with focus on quality, budget and timelines, including making decisions or recommending operational strategies in support of achieving clinical program objectives; Accountable for Early Engagement process with Strategic Partners.
- Oversee Clinical Program Managers assigned to represent Clinical Operations as members of the Global Project Team (GPT) and/or Clinical Subteam(s) (CST), working closely with GPT Leadership to ensure program objectives are met
- Represent Clinical Operations for assigned program in issue escalation/awareness with senior management, e.g. functional or regional executive staff, PRC, alliance governance committees
- Accountable for program budget planning and external spend related to program execution. Works closely with Clinical Program Managers, Project Management, and Finance to ensure budgets, enrollment, and gaiting are accurate; ensures communication of program status, cost and issues to inform timely decision-making by senior management
- Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program(s), including escalation of issues to and participation in governance committees when warranted; accountable for operational risk management strategy in collaboration with Strategic Partners
- Provide TA-level direction to clinical program manager(s) for the development of operational plans including enrollment models and , risk management plans, financial planning and management, communication plans, and monitoring plans in collaboration with CRO/Strategic Partner; accountable for inspection readiness.
- Provide TA-level direction and/or contribute directly to due diligence projects across the therapeutic area.
- Accountable for the review and expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), and updates to IND and NDA documents; Provide expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2 and 3 Meetings, Request for Scientific Advice Meetings, etc.), as appropriate
- Collaborates with and is responsible to the Global TA Clinical Operations Lead to ensure adequate clinical operations resources are assigned to program
- Support functional strategic initiatives and processes managed by Clinical Development Services Group
- Act as a role model for Takeda s values
- Line Manager Clinical Program Managers
- Provides expert counsel for issue resolution, including projects assigned to other staff, when required
- Able to assist in role of Global TA Clinical Operations Lead as required
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
- Supervisory experience
- Demonstrated excellence in project/program management and matrix leadership
- Excellent teamwork, organizational, interpersonal, and problem solving skills
- Fluent business English (oral and written)
- 10+ years experience in pharmaceutical industry and/or clinical research organization, including 7+ years clinical study management.
- Experience must include Phase 2 and 3 studies and global/international programs.
- Experience in more than one therapeutic area is required.
- Demonstrated excellence in leadership and project/program management, including innovative operations approaches to achieving program goals.
- Requires approximately 10-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.
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
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
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