New · posted Nov 7
Kailera · Biotechnology
Associate Director, Clinical Scientist
- Waltham, MA
- Hybrid
- Full-time
- Director
The role
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
What you need
Required Qualifications
- 5+ years of extensive hands-on experience supporting clinical trials in a clinical development role
- Experience working on study teams representing their technical expertise while working collaboratively with colleagues to achieve milestones and goals
- Demonstrates experience reviewing and interpreting clinical trial data listings
- Strong understanding of clinical trial conduct and cross-functional trial workflows
- Ability to work independently while navigating leadership demands by directing the broader study team in partnership with clinical operations
- Exceptional organizational, prioritization, leadership and execution skills
- Demonstrates strong ability to communicate cross-functionally
- Ability to manage multiple studies and deadlines in a fast-paced environment
- A dynamic individual who acts as the subject matter expert (SME) for the cross-functional study team and contributes to the development strategy as a member of a broader team
- Has a thorough understanding of the drug development process from IND/CTA through BLA/NDA submission
- Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization)
- Ability to understand, interpret, and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms
Education
- RN, MS, PhD or PharmD, or equivalent with clinical research experience. Advanced degree and/or professional certification/credentials highly preferred
What you'll do
The Associate Director, Clinical Scientist is a unique opportunity to play a key role in the research and development organization. This role allows for hands-on scientific responsibility of clinical trial execution and delivery. For this role, we are seeking a resourceful and matrixed individual who excels in operating at both the study team and leadership levels to lead in day-to-day execution, data review, and data analysis of the program in support of a Phase 3 pivotal study slated for NDA submission.
This opportunity requires a creative thinker who takes independent initiative to identify and address challenges, while working cross-functionally to drive the development and refinement of clinical and scientific processes and procedures in support of program deliverables.
This individual will assume increasing strategic and leadership responsibilities with broad external scientific communication from study start-up through reporting in support of a growing development portfolio.
In cooperation with the Clinical Science Asset Lead and key R&D stakeholders this individual will contribute to clinical strategy with the following expectations:
- Support the Medical Directors for one or more Phase I–III clinical studies
- Lead studies across the full trial lifecycle, from start-up through database lock and reporting
- Provide scientific input to the efficacy and safety endpoint objectives of clinical trials
- Identify and provide solutions to data trends, inconsistencies, and potential issues; partnering with Data Management, Biostatistics, and Safety
- Collaborate effectively with cross-functional teams including Clinical Operations, Data Management, Biostatistics, Programming, Safety, and Regulatory
- Provide clinical oversight of study execution in collaboration with cross-functional teams and ensure alignment with overall clinical strategy in partnership with the Clinical Science Lead for the program
- Author, review, and contribute to trial documents, such as protocols, amendments, Investigator’s Brochures, and Clinical Study Reports
- Develop and deliver clear, well-structured presentations to study teams
- Understand and communicate the disease and treatment landscape to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy
- Contribute to the development and standardization of templates, processes, infrastructure, and procedures to support clinical development
- Be flexible with travel and attend site related clinical development activities; form and maintain relationships with KOL’s
Pay and benefits
$159,000 – $195,000 a year
Employer provided$159,000—$195,000 USD
For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.
Comprehensive health coverage
Flexible time off and paid holidays
Monthly wellness stipend
401(k) match
Tuition reimbursement
Annual bonus and equity grants
Where you'll work
Waltham, MAHybridOpen in Maps (opens in a new tab)
More jobs in Waltham, MAEqual opportunity, accessibility and legal noticesKailera's statements, word for word
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
E-Verify
Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
Job intelligence
The context around this role
Live data · November 7, 2026
Salary intelligence
How the pay compares
This role's midpoint is 41% below the US median for Clinical Development roles at this level.
This roleEmployer provided
Director roles in Massachusetts64 roles publishing pay
Director roles in the US219 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $159,000 | — | $195,000 |
| Massachusetts (middle half) | $254,500 | $298,500 | $320,875 |
| All US (middle half) | $255,250 | $299,500 | $333,000 |
This role: Kailera's own published range. Comparisons: the base pay employers published on open Clinical Development roles at the same level on Regulatory Jobs, November 7, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Development
The general path across 283 open Clinical Development roles on Regulatory Jobs, with the titles they carry most. Not Kailera's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership17
- Clinical trial conduct12
- Documentation and SOPs4
- Data and digital systems3
- Regulatory submissions2
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Development work in biotechnology, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- FDA21 CFR Part 601(official source, opens in a new tab)Licensing of biological products and changes to an approved BLANamed in the posting
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)Named in the posting
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical 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 E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- 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
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- 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
Company hiring pulse
Kailera on Regulatory Jobs
- 12
- Open roles
- 12
- Distinct roles
- 3
- Locations
By discipline
- Regulatory6 50%
- Clinical5 42%
- Quality1 8%
By level
- Director9 75%
- VP & Executive2 17%
- Senior & Principal1 8%
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Associate Director, Clinical Scientist at Kailera
Open until filled. $159K–$195K a year, employer provided.