Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.

 

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.  

Company Differentiators: 

•    Fully integrated clinical-phase company with internal manufacturing
•    Demonstrated ability to move rapidly from idea to IND
•    Five candidate products in the clinic and two declared pre-clinical programs
•    Robust technology and IP foundation, including our TVE and manufacturing platforms
•    Initial product safety and efficacy data substantiates the value of our platforms
•    Opportunities to expand to other indications and modalities within genetic medicine

GENERAL SUMMARY:

The Sr. Director of Data Management will be an experienced, hands-on data manager who heads the Data Management function of the Data Science group within the Clinical Development organization.  Data Management and the other two functions in the Data Science group, Biostatistics and Statistical Programming, provide critical support for the company’s clinical development programs in gene therapies for retina diseases and other therapeutic areas. 

This Sr. Director of Data Management will provide strategic/technical inputs and oversight to Data Management operational activities, be accountable for high-quality data management deliverables, and manage and build the Data Management team.

RESPONSIBILITIES:

Data Management Leadership: 70% of TIME

  • Provide overall leadership and functional mentorship of the Data Management team, managing and optimizing resources to achieve functional goals and business objectives. 
  • Effectively promote innovation in data sciences in cooperation with peers across all company functions.
  • To improve efficiency, provide strategic and technical leadership across multiple drug development phases, including standardization, automation, process improvement, and technical enhancement in clinical data management (CDM).
  • Ensure high quality and effective conduct of Data Management functions.
  • Guided in developing and implementing data management standards, processes, and infrastructure to ensure adherence to regulatory compliance, ICH GCP guidelines, and good clinical data management practices.
  • Co-lead the design of standardization of the data repository in the Data Sciences group.
  • Collaborate with relevant functional areas to reach key R&D milestones.

Clinical Trial Support: 30% of TIME

  • Utilize and assign resources toward cross-functional design and operationalization of clinical trials from a data management standpoint.
  • Utilize/build resources to work with cross-functional teams to ensure high-quality and prompt data management deliverables for milestone data reviews/analyses/releases.  
  • Accountable to ensure regulatory requirements related to the specific therapeutic areas and implications are integrated into data collection in clinical trials.
  • Ensure strategic and compliant integration of CROs regarding data management activities
  • Keep management abreast of issues and progress on projects.
  • Other responsibilities as assigned: nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

QUALIFICATIONS:

Education:

  • Bachelor’s degree or higher (life-science-related fields preferred)

Experience:

  • 15+ years of data management-related experience in the biotech/pharmaceutical industry or clinical data management service providers. 
  • Work with Retina diseases and/or gene therapy 
  • 6+ years of people management experience (Data Management staff preferred)
  • Deep hands-on operational experience as Data Management Lead in all phases of clinical trials, including development/deployment/validation/maintenance/closeout of the clinical database, coordination of data transfers/reconciliations, training on data management systems, etc.
  • Vendor management and performance assessments
  • In-depth knowledge and expertise with CDISC data standards and models.
  • Proficient in using clinical data management systems (e.g., Medidata Rave) and the data flow, including those from external sources (IRT, safety, central/specialty labs, reading centers, PROs, etc.)
  • Demonstrated proficiency in the data management process and expert knowledge of Good Clinical Data Management Practices (GCDMP) in global clinical trials
  • Demonstrated in-depth understanding of ICH GCP and other applicable regulatory rules and guidelines.
  • Experience in identifying/authoring SOPs and Work Instructions in clinical data management processes
  • Knowledge of the clinical development process.

Skills:

  • Skilled at negotiating with business partners or management and influencing senior-level leaders regarding matters of significance to the organization.
  • Proficient with MS Office (Word, Excel, PowerPoint, etc.).
  • Innate collaborative attitude, with demonstrated ability to work effectively in a small company environment that moves at a tremendous pace.
  • Ability to multi-task in a high-volume environment with shifting priorities and/or conflicting deadlines.
  • Excellent interpersonal communication skills (written and verbal)
  • Excellent organizational and project/time management skills

Base salary compensation range $235,000/yr - $300,000/yr

Please note: the base salary compensation range and actual salary offered to the final candidate depends on various factors: relevant work experience, skills, and years of experience

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
 
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Apply for this Job

* Required
resume chosen  
Dropbox
(File types: pdf, doc, docx, txt, rtf)
Cancel
cover_letter chosen  
Dropbox
(File types: pdf, doc, docx, txt, rtf)
Cancel
When autocomplete results are available use up and down arrows to review
+ Add another education

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 4D Molecular Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

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.

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

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

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.

Enter the verification code sent to to confirm you are not a robot, then submit your application.

This application was flagged as potential bot traffic. To resubmit your application, turn off any VPNs, clear the browser's cache and cookies, or try another browser. If you still can't submit it, contact our support team through the help center.