Associate Director, Clinical Operations Program Lead

Takeda Pharmaceutical Company Limited; United States; Remote; USD 165,000 - 180,000; Full time

Job summary

A leading pharmaceutical company seeks a Senior Manager, Clinical Operations Program Lead to drive operational strategies for clinical programs. This remote position offers a competitive salary and the opportunity to contribute to innovative pharmaceutical solutions. Candidates should have substantial experience in clinical project management and regulatory compliance, and be prepared to lead cross-functional teams in a fast-paced environment.

Benefits

Medical, Dental, Vision Insurance

401(k) with Charitable Contribution Match

Paid Volunteer Time Off

Tuition Reimbursement Program

Qualifications

• 8+ years of experience in the pharmaceutical industry or clinical research organization.
• Experience with early phase clinical studies and multiple therapeutic areas.
• Strong理解 of regulatory requirements including US CFR and ICH GCP.

Responsibilities

• Lead the program-level operational strategy and planning for clinical programs.
• Accountable for the operational execution of clinical programs in compliance with quality standards.
• Oversee clinical program budget planning and manage spend related to clinical execution.

Skills

Operational expertise

Strategic planning

Program management

Risk assessment

Matrix leadership

Regulatory compliance

Education

Bachelor's Degree in Life Sciences

Job description

Senior Manager, Clinical Operations Program Lead

Pay 165k - 180k / year

Location Remote

Employment type Full-Time

Job Description

Req#: R0098082

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 to inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Senior Manager, Clinical Operations Program Lead based in our Cambridge/Lexington office or remotely reporting to the Clinical Operations Leadership team.


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 accomplish their potential through life-cha nging work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commi tment to provide Better Health and a Brighter Future to people around the world.

Here, you will be an important contributor to our inspiring, bold mission.

Goals :

• Provide operational expertise and strategic input on the development of Clinical Development Plans (CDP) supporting the clinical strategy for one or more clinical programs.

• Lead the program-level operational strategy and planning on assigned programs in close collaboration with our strategic partners and other vendors.

• Provide program-level sponsor's operational oversight of our strategic partners and other vendors to ensure the development of the clinical studies on time, and within agreed budget.

• Represent Clinical Operations at the Global Program Team (GPT) and partner with Global Clinical Lead to lead the Clinical Sub Team (CST) accountable for completing the CDP.

ACCOUNTABILITIES:

• Accountable to the GPT for translating the CDP into an operational strategy and plan. Ensure assessment of multiple operational scenarios for execution of the CDP.

• Partner with the CST to develop high-quality study synopsis/protocol by providing operational input and by ensuring all relevant partners are involved and contributing.

• Work with early or late phase COPL counterpart to ensure agreement and seamless interac tions with the GPT.

• Communicate with the Global Program Leader to ensure expectations and activities are aligned.

• Lead the early or late phase clinical program operational strategy and planning on assigned clinical programs in close collaboration with the Clinical Operations Managers (COMs), our strategic partners/other CROs, other vendors, and with the CST.

• Perform program-level oversight of our strategic partners and other vendors to ensure the operational execution and delivery of the assigned clinical p rograms in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), and on budget.

• Work with COMs and counterparts to oversee the performance for all activities assigned to our strategic partners/other CROs/other vendors, i ncluding escalation of issues to governance committees and to senior management when warranted.

• Oversee clinical program budget planning and accountable for external spend related to clinical program execution. Work with COMs, Global Program Management (GP M), Outsourcing Management, and Finance to ensure that budgets, enrolment, and gaiting are accurate.

• Communicate program status, cost and issues to senior management.

• Provide program-level direction and guidance to the COM in development of study strategy operational plans including enrolment models and risk management strategy.

• Be the point of escalation for the COMs for issues that can't be resolved at the study level.

• May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence.

• Review and provide expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, Investigational New Drug Applications (INDs) and Investigational Medicinal Product Dossier (IMPDs), study synopsis & protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and Marketing Authorization Application (MAA), updates to IND and NDA documents, DSURs and other safety reports; Provide expert clinical operations input in to preparation for important regulatory meetings (e.g. End-of-Phase 2, Request for Scientific Advice Meetings).

• Work with COMs, Strategic Partners/other CROs/other vendors to ensure inspection readiness.

• Lead Clinical Operations aspects of inspection readi ness activities, and act as an expert during regulatory inspections.

• Contribute to functional strategic projects and process improvement.

• Seek new ways of working to meet the needs of clinical development.

• Be a role model for Takeda´s values.

• For certain t ypes of studies and programs, COPL may have the following responsibilities:

• Is an important contact between the strategic partners/preferred supplies and the GPT/CST.

• Provide program and study-level direction to the strategic partners/preferred suppliers t o develop study strategy operational plans including enrolment models and risk management strategy.

• Perform site feasibility/capability assessments for programs/studies requiring specialized experimental tests and technologies and work with internal expert s and sites to ensure successful operational outcomes

• Work with Procurement, QA & Legal to qualify new clinical vendors and manage vendors for duration of a study (for vendors contracted directly with Takeda)

EDUCATION AND EXPERIENCE:

• Bachelor's Degree (Li fe Sciences) or international equivalent required.

• 8+ years' experience in pharmaceutical industry or clinical research organization, including 5+ years clinical study/project management.

• Experience must include early phase clinical studies/Phase 2 studies or later phase global/international studies or programs.

• Experience in more than one therapeutic area.

• Expertise in global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP.

• Awareness of local country requirements is also required.

• Excellence in program management, including scenario assessment, risk assessment and contingency planning.

• Excellent matrix leadership.

• Embody a culture of improvement and progress; promote knowledge sharing.

TRAVEL REQUIREMENTS:

• Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.

WHAT TAKEDA CAN OFFER YOU:

• Base Salary Range: $165,000 to $180,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

• The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq.

Empowering Our People to Shine

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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

About the company

Hope and empathy. These two words are not often associated with pharmaceutical companies. But here at Takeda, our people are motivated to serve patients with integrity, respect, and empathy. Driven by our mission, we seek to bring hope of better health and a brighter future to those we impact. To do this, we focus on our chosen core therapeutic areas:OncologyGastroenterologyNeuroscienceDevelop life-saving vaccinesNo matter the region, business unit, function, or team, everyone at Takeda matters. Every one of our employees is a vital contributor to our bold, inspiring mission.

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