Full-Time

Associate Director Clinical Operations Program Lead

Oncology

Takeda

Takeda

10,001+ employees

Global biopharmaceutical firm; R&D-driven NMEs

Compensation Overview

$154.4k - $242.6k/yr

+ Short-term incentives + Long-term incentives + 401(k) match

Massachusetts, USA

Remote

Bachelor's

Category
Biology & Biotech (1)

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Requirements
  • A Bachelor’s Degree or international equivalent is required; Life Sciences is preferred.
  • At least 10 years of experience in the pharmaceutical industry and/or a clinical research organization, including at least 7 years of clinical study or project management experience.
  • Experience with early-phase clinical studies, Phase 2 studies, or later-phase global programs.
  • Expertise in global regulatory and compliance requirements for clinical research, including U.S. Code of Federal Regulations, European Union Clinical Trial Directive, and International Council for Harmonisation Good Clinical Practice.
  • Awareness of local country requirements is required.
  • Demonstrated excellence in program management, including scenario assessment, risk assessment, and contingency planning.
  • Demonstrated matrix leadership and communication skills.
  • Ability to influence without authority.
  • Teamwork, communication, organizational, interpersonal, conflict-resolution, and problem-solving skills.
  • Ability to take measured risks, think innovatively, and challenge the status quo.
  • Pragmatic approach and willingness to drive and support change.
  • Comfort with ambiguity.
  • Commitment to continual improvement, innovation, and knowledge sharing.
  • Fluent business English, oral and written.
Responsibilities
  • Develop and lead the program-level operational strategy and planning for assigned programs in collaboration with strategic partners and vendors.
  • Represent Clinical Operations on the Global Program Team and partner with the Global Clinical Lead to lead the Clinical Sub Team responsible for developing and executing the Clinical Development Plan.
  • Provide program-level sponsor operational oversight of strategic partners and vendors to ensure clinical studies are executed on time, with high quality, and within the agreed budget.
  • Translate the Clinical Development Plan into an optimal operational strategy and plan, assess operational scenarios, and maintain alignment with the Global Program Leader and Global Clinical Lead.
  • Develop and lead the clinical program operational strategy in collaboration with Clinical Operations Managers, strategic partners, contract research organizations, and other vendors.
  • Serve as the escalation point for Clinical Operations Managers and oversee strategic partner, contract research organization, and vendor activities.
  • Plan budgets and remain accountable for external spend related to clinical program execution; coordinate with Clinical Operations Managers, Global Program Managers, and Finance to maintain accurate budgets, enrollment, and gating.
  • Participate in strategic cross-functional initiatives for process and business improvements.
  • Communicate program status and issues to support timely decision-making by senior management.
  • Participate in business development, in-licensing, and alliance evaluations by providing operational due diligence.
  • Review and provide expert clinical operations input into clinical documents related to drug development and preparation for key regulatory meetings.
  • Lead Clinical Operations aspects of inspection-readiness activities and act as a subject-matter expert during regulatory inspections.
  • Lead or participate in cross-functional strategic initiatives and process improvement.
  • Seek more efficient ways of working to meet clinical development needs.
  • Demonstrate advanced leadership behaviors and act as a role model for company values.
Desired Qualifications
  • An advanced degree is highly desirable.
  • Experience in more than one therapeutic area is highly desired.

Takeda is a global biopharmaceutical company focused on discovering and delivering medicines and vaccines to improve patient health. It relies on extensive research and development to create new molecular entities (NMEs) and bring them to market, aiming for up to 15 product launches through FY2024 from a pipeline of 11 NMEs. Revenue comes mainly from selling pharmaceutical products, supported by about 41,000 third-party suppliers worldwide. The company differentiates itself through a deep history (over 240 years), a broad portfolio of global brands, and a patient-centric approach that places patients’ needs at the center of its operations while pursuing environmental sustainability. Takeda’s goal is to advance health globally by turning scientific innovations into accessible therapies, maintaining long-term growth through steady product innovation and responsible operations.

Company Size

10,001+

Company Stage

IPO

Headquarters

Tokyo, Japan

Founded

1781

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Simplify Jobs

Simplify's Take

What believers are saying

  • August 2026 FDA approval for MIMRYLO unlocks near-term U.S. oncology revenue.
  • Takeda expects ORZEYFUL U.S. launch by November 2026, pending DEA scheduling.
  • Q1 FY2026 new launches grew 22.6%, offsetting mature-brand declines and supporting guidance.

What critics are saying

  • May 18, 2026 AMITIZA verdict exposed Takeda to $2.6 billion treble-damage risk.
  • Takeda plans 4,500 FY2026 cuts, signaling launch execution pressure and organizational churn.
  • Patent erosion crushed VYVANSE sales 60.7% at constant currency in Q1 FY2026.

What makes Takeda unique

  • ORZEYFUL became the first orexin agonist approved for narcolepsy type 1 in 2026.
  • MIMRYLO offers first-in-class hepcidin mimetic therapy for polycythemia vera after FDA approval.
  • Takeda pairs global scale with Japanese discovery, including Shonan-led neurology innovation.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Retirement Plan

401(k) Company Match

Paid Vacation

Paid Sick Leave

Wellness Program

Tuition Reimbursement

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
Associated Press
Sep 9th, 2026
Trialbee unveils AI-powered patient screening chatbot at DPHARM 2026

Trialbee, a patient recruitment platform provider, will present at DPHARM 2026 in Boston on 15-16 September. The Swedish-American company will unveil AI-powered patient screening in its Honey Platform, enabling conversational AI chatbots to conduct initial candidate assessments whilst giving patients the option to speak with recruitment specialists. Trialbee will present jointly with pharmaceutical company Takeda on integrating their respective platforms to build research-ready patient communities that extend beyond single trials. The company will also participate in a panel discussing AI applications at clinical trial sites. The Honey Platform has added several AI features this year, including candidate summaries, duplicate detection, and recruitment data analysis. Trialbee supports over 6,000 research sites across 50 countries and reports a 91% repeat business rate with biopharmaceutical companies.

Associated Press
Sep 9th, 2026
Onco360 selected as specialty pharmacy partner for rare blood cancer drug MIMRYLO

Onco360, a US independent speciality pharmacy, has been selected by Takeda Pharmaceuticals as an ultra-narrow limited distribution partner for MIMRYLO (rusfertide). The treatment is indicated for erythrocytosis in adults with polycythemia vera. MIMRYLO is a mimetic of the endogenous hormone hepcidin that blocks the iron transporter ferroportin. This inhibition reduces iron availability for red blood cell production, resulting in lower hematocrit levels. The drug's approval was based on the phase 3 VERIFY study, a global, randomised, open-label clinical trial. The primary endpoint measured the proportion of patients achieving response during weeks 20-32, defined as the absence of phlebotomy eligibility. The most common adverse reactions were injection site reactions at 56% and anaemia at 16%.

Yahoo Finance
Aug 31st, 2026
Takeda wins FDA approval for first-in-class blood cancer drug, triggering $275M payment to Protagonist

The FDA approved Takeda Pharmaceutical's MIMRYLO (rusfertide) for polycythemia vera, a blood cancer causing red blood cell overproduction. The first-in-class drug functions as a hepcidin mimetic, regulating iron distribution to control hematocrit levels and prevent life-threatening complications like strokes and pulmonary embolisms. Approval was based on the Phase 3 VERIFY study involving 293 patients. Those receiving MIMRYLO alongside standard care achieved superior hematocrit control, reduced phlebotomy needs, and improved fatigue compared to placebo. Takeda commercialises MIMRYLO under a 2024 agreement with Protagonist Therapeutics, which discovered the drug. The approval triggers $275 million in payments to Protagonist—a $200 million opt-out fee plus $75 million milestone. Protagonist remains eligible for up to $875 million in additional milestones and tiered royalties of 14% to 29% on worldwide net sales.

Associated Press
Aug 28th, 2026
US FDA approves Takeda's Mimrylo for polycythemia vera treatment

Takeda has received US FDA approval for MIMRYLO (rusfertide), a first-in-class treatment for erythrocytosis in adults with polycythemia vera (PV), a blood cancer. The drug is a hepcidin mimetic that regulates iron distribution and red blood cell overproduction to control hematocrit levels. The approval was supported by the Phase 3 VERIFY study involving 293 PV patients. Results showed MIMRYLO plus standard care demonstrated higher response rates than placebo, including better hematocrit control, reduced phlebotomy needs, and improved fatigue scores. PV affects approximately 90,000 people in the US. An estimated 78% of patients experience uncontrolled hematocrit with current standard care. The most common adverse events were injection site reactions and anaemia. MIMRYLO is administered once weekly via subcutaneous injection. Takeda is working with regulators outside the US for potential global availability.

Associated Press
Aug 24th, 2026
Japan approves Orzeyful as first medicine targeting narcolepsy type 1's underlying cause

Takeda announced Japan's Ministry of Health, Labour and Welfare has approved ORZEYFUL (oveporexton) for treating narcolepsy type 1 in adults. The oral medication is the first to address the underlying orexin deficiency causing the disease, rather than just managing individual symptoms. Narcolepsy type 1 is a chronic neurological condition characterised by excessive daytime sleepiness, cataplexy, disrupted sleep, and other symptoms that significantly impact patients' daily lives. Diagnostic delays average more than 10 years. The approval follows global Phase 3 trials showing statistically significant improvements across the full range of symptoms. Common side effects included insomnia, urinary urgency and frequency, and excessive saliva. ORZEYFUL is also approved in China and the United States. Takeda developed the first-in-class orexin receptor 2 agonist in its Japanese laboratories and plans to launch the treatment quickly.