Regulatory Jobs
Hero Gradient Background
A white Takeda plant building with the red Takeda logo in Narita, Japan, under a clear blue sky
Takeda logo

New · posted Oct 31

Takeda · Pharmaceuticals

Associate Medical Director, Clinical Science, GI2 TAU

  • Cambridge, MA
  • Hybrid
  • Full-time
  • Director
Save
EmploymentFull-time
DeadlineOpen until filled

The role

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Medical Director, Clinical Science, GI2 TAU in our Cambridge, MA office.

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 realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

Trial Medical Monitoring

  • Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety.
  • Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance.
  • Oversees non-medical clinical scientists with respect to assessment of these issues.
  • Makes final decisions regarding study conduct related to scientific integrity

External Interactions

  • Directs interactions with key opinion leaders relevant to assigned compounds and therapeutic area.
  • Provides leadership in meetings and negotiations with key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders
  • Leads incorporation of advice/recommendations received into the design of clinical studies and programs as appropriate.

Due Diligence, Business Development and Alliance Projects

  • Responsible for evaluation of potential business development opportunities, conducts due diligence evaluations assessing scientific, medical, and development feasibility, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans.
  • For ongoing alliance projects, will interface with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner.

What you need

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

  • MD or internationally recognized equivalent plus 3 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
  • Subspecialty in Immunology preferred.
  • Phase 3 Clinical Trial experience preferred
  • Previous experience successfully leading matrix teams preferred.
  • Management experience preferred

ACCOUNTABILITIES

  • Represents Clinical Science on Project or Clinical Teams and may serve as the Clinical Science leader on these teams
  • Supports the Global Project Team to ensure that the clinical team activities are aligned with the global strategy
  • Contributes to the overall Asset Strategy by supporting the development of the Clinical Development Plan, leads the development of Clinical Protocols and other documents needed for CDP and study execution and regulatory submissions. Recommends scope, complexity and size, and influences the budget of all aspects of a study
  • Ongoing work output will involve continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
  • Recommends high impact global decisions.
  • Responsible for monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. A significant error in judgment may result in loss of approvability and/or commercial viability of a product.

·    Synopsis / Protocol Development, Study Execution, & Study Interpretation

  • Oversees Clinical Science department activities relating to the preparation/ approval of Synopses, Protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists involved in these activities and is accountable for the successful design and interpretation of clinical studies
  • Presents study conclusions to Management and determines how individual study results impact the overall compound strategy
  • Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
  • Superior communication, strategic, interpersonal and negotiating skills
  • Ability to proactively predict issues and solve problems
  • Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
  • Diplomacy and positive influencing abilities

Knowledge

  • Regional/global Regulatory requirements
  • GCP/ICH
  • Emerging research in designated therapeutic area

Travel requirements

  • Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
  • Requires approximately 15 - 25% travel

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

What you'll do

Leadership, Task Force Participation, Upper Management Accountability

  • Interacts directly with research division based on pertinent clinical and development expertise.
  • Represents clinical science on high impact/priority task forces across the organization or external to the company.
  • Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities.

Pay

$198,500 – $311,850 a year

Employer provided
How this compares

U.S. Base Salary Range

$198,500.00 - $311,850.00


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

Cambridge, MAHybridOpen in Maps (opens in a new tab)

More jobs in Cambridge, MA

Working conditions

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

About twenty smiling Takeda interns with name badges posed on a deck with the Boston skyline behind

From the posting

About Takeda

For Location

USA - MA - Cambridge - Binney St

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.

Takeda company page · 64 open roles
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 · October 31, 2026

Salary intelligence

How the pay compares

This role's midpoint is 14% below the US median for Clinical Development roles at this level.

This roleEmployer provided

$198,500 to $311,850 a year

Director roles in Massachusetts40 roles publishing pay

Middle half $255,000 to $308,250, median $298,000

Director roles in the US93 roles publishing pay

Middle half $258,000 to $318,500, median $298,000
Annual base pay
Annual base payLowMedianHigh
This role$198,500—$311,850
Massachusetts$255,000$298,000$308,250
All US$258,000$298,000$318,500

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, October 31, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Clinical Development

The general path across 116 open Clinical Development roles on Regulatory Jobs, with the titles they carry most. Not Takeda's own promotion track.

  1. Earlier

    Associate & Specialist

    Often: Summer Intern

  2. Earlier

    Senior & Principal

    Often: Clinical Scientist · Clinical Scientist/Sr. Clinical Scientist, Oncology

  3. One step back

    Manager

    Often: Manager, Aesthetics Clinical Development · Senior Manager, Clinical Scientist

  4. This role

    Director

    Often: Senior Director, Clinical Development · Executive Medical Director, Oncology Clinical Development

    $298K median96 open
  5. Next step

    VP & Executive

    Often: Vice President, Clinical Development · Associate Vice President

    $360K median11 open

Skills DNA

What this role leans on

How many of the posting's 42 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 1 lineDocumentation and SOPs: 2 linesRegulatory submissions: 2 linesClinical trial conduct: 8 linesCollaboration and leadership: 11 linesGMPDocumentationSubmissionsClinical trialsTeamwork
  • Collaboration and leadership11
  • Clinical trial conduct8
  • Documentation and SOPs2
  • Regulatory submissions2
  • GMP and compliance1

Company hiring pulse

Takeda on Regulatory Jobs

64
Open roles
61
Distinct roles
16
Locations

By discipline

  • Regulatory24 38%
  • Clinical21 33%
  • Quality18 28%

By level

  • Director37 58%
  • Senior & Principal12 19%
  • Manager9 14%
See all 64 Takeda roles

More roles at Takeda

All 64 Takeda roles

Similar Clinical Development roles elsewhere

Associate Medical Director, Clinical Science, GI2 TAU at Takeda

Open until filled. $199K–$312K a year, employer provided.

Job alerts