New · posted Nov 13
Takeda · Pharmaceuticals
Clinical Science Lead
- Boston, MA
- On-site
- Full-time
- Director
The role
In this Director level role, you will help shape the scientific and operational strategy for clinical studies across a diverse evidence generation portfolio. You will play a key role in advancing Phase 3B and Phase 4 interventional and non-interventional studies, real-world evidence initiatives, collaborative research, and investigator-initiated activities. Working across functions, you will help ensure studies are scientifically robust, operationally feasible, and delivered with a strong focus on quality, compliance, and business priorities. You will be part of a team that supports evidence-based decision-making while advancing efficient, scalable, and digitally enabled approaches to clinical research. Your work will contribute to the successful design, implementation, governance, and delivery of studies that generate meaningful evidence and support organizational goals, while promoting the appropriate use of digital and artificial intelligence-enabled tools to strengthen planning, oversight, analytics, and decision-making.
How You Will Contribute
- Provide scientific and operational leadership for the planning, implementation, oversight, execution, and reporting of clinical, real-world evidence, and externally sponsored studies.
- Lead study design and document development through the creation, review, and approval of protocols, amendments, study concepts, and related materials.
- Ensure study quality and feasibility by aligning study designs and execution plans with evidence generation priorities and stakeholder needs.
- Manage study delivery and performance by overseeing timelines, enrollment, budgets, operational metrics, risks, and quality indicators.
- Interpret and communicate clinical findings by translating complex clinical and safety data into recommendations, reports, publications, and decision-support materials.
- Partner across functional teams to support compliant study governance, vendor oversight, contracting, reporting, and archiving activities.
- Lead vendor and external partnership management while maintaining budget stewardship across the assigned portfolio.
- Drive continuous improvement and innovation through the adoption of digital and artificial intelligence-enabled tools that enhance evidence generation and study management.
What you need
- Advanced degree in a scientific, clinical, epidemiologic, quantitative, or health-related discipline.
- 10+ years of experience in clinical development, evidence generation, clinical research, or related disciplines involving interventional and non-interventional studies.
- Significant experience in clinical science, clinical development, study implementation, epidemiology, real-world evidence, or related biopharmaceutical functions.
- Strong experience authoring, reviewing, and approving clinical trial protocols and related study documentation.
- Experience leading global or multi-country clinical studies through implementation and publication.
- Extensive knowledge of interventional and non-interventional study designs, good clinical practice, applicable regulations, ethics, quality standards, and standard operating procedure-driven practices.
- Demonstrated ability to interpret complex clinical and safety data and communicate findings effectively to diverse audiences.
- Strong program leadership, stakeholder management, vendor oversight, decision-making, and team leadership skills, including experience using digital and artificial intelligence-enabled tools in a regulated environment.
Pay
$177,000 – $278,080 a year
Employer providedU.S. Base Salary Range
$177,000.00 - $278,080.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
For information about our benefits, please click here.
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
Where you'll work
Boston, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Boston, MAWorking conditions
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
From the posting
About Takeda
For Location
Boston, MA
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Equal opportunity, accessibility and legal noticesTakeda's statements, word for word
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.
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.
Job intelligence
The context around this role
Live data · November 13, 2026
Salary intelligence
How the pay compares
This role's midpoint is 24% below the US median for Clinical Development roles at this level.
This roleEmployer provided
Director roles in Massachusetts67 roles publishing pay
Director roles in the US216 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $177,000 | — | $278,080 |
| Massachusetts (middle half) | $253,000 | $297,000 | $321,750 |
| All US (middle half) | $254,500 | $300,000 | $335,500 |
This role: Takeda's own published range. Comparisons: the base pay employers published on open Clinical Development roles at the same level on Regulatory Jobs, November 13, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Development
The general path across 288 open Clinical Development roles on Regulatory Jobs, with the titles they carry most. Not Takeda's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Clinical trial conduct6
- Documentation and SOPs3
- GMP and compliance2
- Investigations and CAPA1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Development work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical history
Company hiring pulse
Takeda on Regulatory Jobs
- 68
- Open roles
- 68
- Distinct roles
- 16
- Locations
By discipline
- Clinical26 38%
- Regulatory25 36%
- Quality17 25%
By level
- Director42 61%
- Senior & Principal11 16%
- Manager9 13%
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Clinical Science Lead at Takeda
Open until filled. $177K–$278K a year, employer provided.