Back to jobs
New

Assoc. Director, Data Management

Lexington, MA

Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders. At Kiniksa, talented individuals are trusted and empowered to make a real impact—shaping the future of medicine while improving the lives of patients who need it most.

Reporting to the Senior Director, Biostatistics, the Associate Director will serve as a strategic data management leader across clinical studies. This role will provide end-to-end leadership from protocol review and study start-up through database lock, regulatory submission support, long-term follow-up, and archival, while ensuring high-quality, analysis-ready clinical data. The Associate Director, Clinical Data Management ensures optimized data collection, flow and access across EDC and non-EDC data sources. 

This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Responsibilities (including, but not limited to):  

  • Accountable for data management activities for Kiniksa clinical studies and oversee CRO data management activities that support ongoing clinical programs
  • Review protocols and study strategies to ensure feasible, compliant and effective data collection.
  • Lead cross-functional data review and align stakeholders on quality, timelines and risk mitigation.
  • Provides input to improve data processes and organization in alignment with other development functions
  • Develop and maintain SOPs and working practice documents for data management tasks in collaboration with other functions
  • Drive study and program milestones, proactively identifying risks and implementing solutions.
  • Review clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis)
  • Lead EDC database (DB) specification process internally and ensure the database is built to capture the protocol schedule and endpoints
  • Review / Develop DB clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations
  • Review / Develop Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs
  • Oversee the User Acceptance Testing (UAT) by CRO and Coordinating UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report
  • Ensure clinical data within EDC is of high quality to support lock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to data reconciliation and/or coding
  • Accountable for eDairy, PRO, and other electronic data collection on portable devices to make sure the design of data collection meets the scientific objective
  • Assist in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit
  • Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs
  • Coordinate and communicate with DB vendors on consistent basis to address Clinical team’s requests, project plans, and/or eCRF development activities
  • Participates in the preparation and presentation of data, when applicable
  • Ensures data system compliance by following the established guidelines of national and international regulatory authorities
  • Set up and maintain task related to building database on Medidata URL and generate listings in Clinical data studio tool for data cleaning.
  • Support regulatory submissions, health authority responses, inspection readiness, and audits.

Standout Skills for Impact: 

  • Strategic thinking to align data management with long-term organizational objectives
  • Strong communication skills
  • Analytical and problem-solving skills to identify data issues and implement solutions
  • Oversight and leadership to guide teams, manage projects, and ensure adherence to protocols

Qualifications and Experience:  

  • Requires a Bachelor’s degree or higher (MS preferred) in relevant scientific field or discipline with a minimum of 6+ years of clinical data management experience in pharma/biotech
  • Proficient in clinical data collection, cleaning and analysis for Phase I- IV clinical trials in a pharmaceutical industry/clinical research company
  • Experience working in an outsourced data management model
  • Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes
  • Familiarity with GCP, ICH and FDA requirements as applicable for clinical data management
  • Prior experience filing a BLA or NDA preferred
  • Ability to manage multiple initiatives and shifting priorities within a small company environment
  • Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment

Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

Pay Range

$198,000 - $210,000 USD

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. 

Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Kiniksa Pharmaceuticals’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 07/31/2029

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.