Director, Clinical Operations

3 years ago

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

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 Director, Clinical Operations based in our Cambridge/Lexington office or remotely.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director Clinical Operations Program Lead working on the Clinical Operations team, you will be empowered to lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan, and a typical day will include:

OBJECTIVES:

Lead and direct the execution of clinical program(s) within a Therapeutic Area (TA); contribute to the Clinical Development Plan and associated operational strategy, in support of the Asset Strategy.
Provide Clinical Operations leadership under the direction of the Senior Director, Clinical Operations:

Lead and manage multiple clinical programs within the TA through the direct supervision of additional Clinical Operations leaders
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 or potentially a suite of programs, 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 (CSTs)). The Director, Clinical Operations will also take on functional leadership responsibilities including line management, providing expert consult for issue resolution and assisting the Senior Director, Clinical Operations.

ACCOUNTABILITIES:

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.
Oversee COPLs assigned to represent Clinical Operations as members of the Global Program Team (GPT) and/or 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 Global Program 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 COPLs/APLs 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 Senior Director, Clinical Operations 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 for Clinical Operations staff.
Recognized as a clinical operations expert by other functions and ability to represent and lead cross functional initiatives.
Provides expert counsel for issue resolution, including projects assigned to other staff, when required.
Able to assist in role of Senior Director, Clinical Operations as required.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

Bachelor's Degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable.
12+ years' experience in pharmaceutical industry and/or clinical research organization, including 9+ years clinical study management.
Experience must include early phase experience or Phase 2 and 3 studies and global/international programs.
Experience in more than one therapeutic area is advantageous.
Demonstrated excellence in leadership and project/program management, including innovative operations approaches to achieving program goals.
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).
Able to influence without authority.
Excellent teamwork, organizational, interpersonal, conflict resolution and problem solving skills.
Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo.
Pragmatic and willing to drive and support change.
Is comfortable with ambiguity.
Support a culture of continual improvement and innovation; promote knowledge sharing.

TRAVEL REQUIREMENTS:

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

Location and Salary Information:

Location(s): Cambridge, MA, Lexington, MA or remote.
Base Salary Range: $160,000 - $229,000 based on candidate professional experience level.

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
#LI-Remote

posted by