Senior Manager, Site Budgeting and ContractingRemote
- Job Type: Full Time
- Job Level: Senior
- Travel: Minimal
At Takeda, we exist to create better health for people and a brighter future for the world. While we continually evolve science and technology, our ambition remains steadfast — we move science forward so we can transform more lives. The Global Development Office (GDO) maintains a laser focus on Study Management and Site Engagement, Clinical Trial Innovation, Clinical Supply Chain and Patient Safety to ensure absolute quality and enable the predictable delivery of our innovative pipeline.
Through its collaborative process, the GDO team leverages data, digital and analytics to improve speed, quality, performance and predictability within every area of clinical development. We’re building a platform to visualize operational data and enable predictive analytics, while leveraging digital technologies to support clinical supply chain and patient safety. GDO also partners with external organizations and leading academic institutions, such as MIT, to spark innovation in AI and Machine Learning focused on better patient outcomes.
At the heart of GDO are our people: we are committed to building a more diverse, equitable and inclusive culture not only within our own walls and our communities, but also across our clinical trials. It is our passion for people that transforms our work into meaningful action. Come join a team that has earned trust for more than two centuries and advances transformative therapies with honesty, integrity and fairness.
Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Manager, Site Budgeting and Contracting in Cambridge, MA or remotely reporting to the Director, Site Budgeting and Contracting.
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 work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
Here, you will be a necessary contributor to our inspiring, bold mission.
- Support delivery of global site contracting and budgeting (SB&C) tasks, partnering with Sites, CRO and internal/external Study and Startup team members.
- Manage setup, escalations and review of global site budgets and contracts from CRO partners and internal team members to ensure contract execution and study startup forecasts are achieved.
- Guide negotiation and administration of master clinical trial contracts
- Support the development and mentoring of creative processes, methodologies, data, and technologies that will ensure ongoing improvements in the delivery of SB&C services.
- Manage negotiations, finalization and administration of Master Clinical Trial Agreements.
- Responsible for assigned study level site contracting and budgeting function to develop, negotiate, administrate and execute assigned Clinical Trial Agreements and budgets.
- Partner with Study Start up Managers, CROs, Clinical Operations teams, and TAU partners to improve overall SB&C metrics and implement processes.
- Guide, oversee, and train internal and external partners regarding delivering site budgeting and contracting activities to support Clinical Programs.
- Ensure standards are developed and applied to the site budgeting and contracting process across project portfolios and support continuous improvement activities while developing TA-aligned strategies.
- Partner with Study Startup, CRO and Clinical Operations teams as an escalation point for global budget escalations outside of budget parameters.
- Leverage leading industry tools and data sources to provide budget and contract feedback aligned with Takeda parameters and fair market value guidance.
- Recognize and improve potential delays and escalate non-performance.
- Manage site contracts and budgets negotiation timelines to ensure sites are "Ready To Enroll" to the Startup Project Plan.
- Resolve escalated issues identified by the site activation sub-team in partnership with the Study Manager through the Study Management Operations Sub-team with the CRO.
- Mentor and support development of internal Study Startup team members.
EDUCATION AND EXPERIENCE:
- BS degree or international equivalent
- 6 or more years of experience in clinical research site contracting and budgeting with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor.
- At least 3 years of global site budgeting and contracting oversight or negotiation.
- Experience with the pharmaceutical industry and clinical drug development.
- Experience with Clinical Trial Agreements, budgeting and fair market value principles.
- Knowledge of FDA and ICH-GCP guidelines for conducting clinical research.
- Explain data, facilitate decision-making processes to be data-driven.
- Expertise in principles driving country/site budgeting and contracting strategies.
WHAT TAKEDA OFFERS YOU:
Base Salary Range: $130,200 - $186,000. 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 and 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.
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.
LocationsMassachusetts - Virtual
Time TypeFull time
The heart of our work
Shining a light on new perspectives
Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.
Working at Takeda
InclusionHere, you will feel welcomed, respected, and valued as a vital contributor to our global team.
CollaborationA strong, borderless team, we strive together towards our priorities and inspiring mission.
InnovationBold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top WorkplaceRecognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Work-LifeOur people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
EmpowermentThrough trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
Create an exceptional people experience.
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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