Director, Data Management
7 days ago
Job Title: Director, Data Management
Job Location: United States
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Director
About Apogee TherapeuticsFounded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.
Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”
We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.
If this sounds like you, keep reading
Role Summary
We are seeking a Director of Data Management. In this position you will be responsible for both management and technical aspects of Data Management elements of clinical trials. You will manage the direction, planning, execution, and interpretation of all the data management activities related to clinical trials/research (Phase I-IV), including participating in defining corporate practices required for handling the data. In this role you will build the DM standards/good practices as well to mentor junior data manager(s).
Key Responsibilities
- Provide operational leadership to the direction, design, planning, execution, collection and handling of all clinical data to the highest quality standards
- Coordinates and participates in the review of clinical data, including support for data review systems, development of processes and guidelines, and production of custom database reports
- Ensure the quality of clinical data within EDC systems at the time of database snapshots and database locks, including definition, documentation and management of all processes related to database snapshots and locks
- Responsible for building effective DM vendor relationships including being involved in RFP development, contract negotiation and selection of DM CROs and/or technology, as needed
- Work closely with CROs to prepare and ensure proper development and execution of data management activities
- Review protocols to ensure database feasibility
- Provide effective oversight of all CRO data management related deliverables
- Ensure that eCRFs, database interfaces, programmed edit checks and external data files, CRF completion guidelines are designed and built in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and regulatory submissions
- Collaborate with Biostatistics and Statistical Programming to develop data review standards and tools, including visualization tools if needed
- Work collaboratively with Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data in timely fashion
- Responsible for documentation and archival standards for Data Management deliverables including systems, databases, programs, and specifications, and ensures DM project documentation is audit-ready
- Ensure that all clinical trials have complete and accurate supporting documentation for regulatory submission including raw datasets and bookmarked, annotated CRFs
- Responsible for development, maintenance and governance of CDM standards (standard eCRFs, CDASH, etc.)
- Ensure that data management activities are conducted in accordance with GCP, GCMP, internal SOPs and all regulatory requirements
- Build and mentor a team of data manager(s) to effectively support clinical trials and pipelines
- Bachelor’s Degree in health-related field
- Minimum of 10 years of clinical data management in pharma/biotech/healthcare industry
- Minimum of 5 years of direct people management experience, including a remote workforce
- Must be able to demonstrate extensive experience in the design, execution, collection, and cleaning of data for clinical studies
- Technology proficiency in Data Management Systems
- Knowledge of clinical research including regulatory requirements GCP/ICH Data Quality
- Extensive experience managing CROs and other data vendors
- Submission experience (NDA, sNDA and BLAs)
- Knowledge of Good Clinical Practice
- EDC and eCOA experience (Medidata, Veeva, etc.)
- Excellent written and oral communication skills
- Ability to keep pace in a fast-moving organization and navigate ambiguity
- Experience working in a remote virtual environment
- Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
- This position requires up to 10% travel to company and team/functional meetings
What We Offer
- A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
- Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
- Flexible PTO
- Two, one-week company-wide shutdowns each year
- Commitment to growing you professionally and providing access to resources to further your development
- Apogee offers regular all team, in-person meetings to build relationships and problem solve
Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
To review our privacy policy, click here
Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
https://lifelancer.com/jobs/view/ca8cc4e47c00a63fe62ed7d9ac8beb53
-
Enterprise Data Management Director
3 weeks ago
New York, New York, United States Citigroup, Inc. Full time**Job Description**We are seeking an experienced Enterprise Data Management Director to join our team at Citigroup, Inc. This role involves developing and implementing a comprehensive data governance strategy that aligns with our business and regulatory requirements.As Enterprise Data Management Director, you will be responsible for managing and leading data...
-
Director, Clinical Data Management
7 days ago
New York, United States EPM Scientific - Phaidon International Full timeJob Title: Director, Clinical Data Management (CDM)Location: New YorkJob Summary: The Director of Clinical Data Management (CDM) will assist with leading the CDM team in the design, implementation, and management of clinical data systems and processes. This role is responsible for ensuring the accuracy, integrity, and security of clinical trial data.Key...
-
Director, Clinical Data Management
4 weeks ago
New York, United States EPM Scientific Full timeJob Title: Director, Clinical Data Management (CDM)Location: New YorkJob Summary: The Director of Clinical Data Management (CDM) will assist with leading the CDM team in the design, implementation, and management of clinical data systems and processes. This role is responsible for ensuring the accuracy, integrity, and security of clinical trial data.Key...
-
Enterprise Data Management Director
3 hours ago
New York, New York, United States PRI Technology Full timePRI Technology is committed to delivering innovative solutions to our clients. We are seeking an experienced professional to lead our Enterprise Data Management efforts as the Enterprise Data Management Director.This role requires a strong understanding of data management principles, as well as excellent leadership and communication skills. If you have a...
-
New York, New York, United States PitchBook Data Full timeAbout the RolePitchBook Data is a leading provider of data and technology solutions for the financial industry. We are seeking a highly skilled Marketing Director to join our team. As a key member of our marketing department, you will be responsible for developing and executing go-to-market strategies for our asset management solutions.Key...
-
Product Manager for Data Solutions
3 weeks ago
New York, New York, United States PitchBook Data Full timeAbout the RolePitchBook Data is looking for an experienced Product Manager to lead the development and execution of our data technology tools. This role requires strong leadership and collaboration skills, with the ability to work closely with cross-functional teams to deliver high-quality products.The successful candidate will have a proven track record of...
-
Director Data
1 month ago
New York, United States Gain Theory Full timeAbout Gain TheoryGain Theory is part of WPP, a creative transformation company that uses the power of creativity to build better futures for its people, planet, clients, and communities.Gain Theory is a global marketing effectiveness consultancy, that uses data and analytics to deliver successful business outcomes for clients. Our vision is to inspire...
-
Director Data
16 hours ago
New York, United States Gain Theory Full timeAbout Gain TheoryGain Theory is part of WPP, a creative transformation company that uses the power of creativity to build better futures for its people, planet, clients, and communities.Gain Theory is a global marketing effectiveness consultancy, that uses data and analytics to deliver successful business outcomes for clients. Our vision is to inspire...
-
Data Technology Product Manager
2 weeks ago
New York, New York, United States PitchBook Data Full timeOverviewAt PitchBook Data, we're on a mission to revolutionize the way our customers access and utilize data. As a Product Manager II, you'll play a critical role in shaping the future of our product roadmap. Our team is passionate about creating innovative solutions that meet the evolving needs of our customers.CompensationThe estimated annual salary for...
-
Product Management Director
3 weeks ago
New York, New York, United States Marsh & McLennan Companies, Inc. Full timeExciting Opportunity for a Product Management Director at Marsh McLennanWe are seeking an experienced product management professional to lead our Data Strategy team. This is a hybrid role that requires working at least three days a week in the office.About the RoleThe Data Strategy team cultivates and builds on data assets across all functions and lines of...
-
Sales Director
3 weeks ago
New York, New York, United States VAST Data Full timeSales Excellence at VAST DataVAST Data is a leading provider of data management solutions, and we are seeking an experienced sales executive to join our team. As a Sales Director, you will be responsible for driving sales growth and expanding our customer base through strategic planning, prospecting, and relationship-building. You will work closely with...
-
Risk Data Management Director
7 days ago
New York, United States SMBC Full timeSMBC Group is a top-tier global financial group. Headquartered in Tokyo and with a 400-year history, SMBC Group offers a diverse range of financial services, including banking, leasing, securities, credit cards, and consumer finance. The Group has more than 130 offices and 80,000 employees worldwide in nearly 40 countries. Sumitomo Mitsui Financial Group,...
-
Data Product Manager
2 days ago
New York, United States People Data Labs Full timeJob DescriptionJob DescriptionAbout UsAt People Data Labs (PDL), we do the heavy lifting of data collection and standardization so our customers can focus on building and scaling innovative, compliant data solutions. Our sole focus is on building the best data available by integrating thousands of compliantly sourced datasets into a single,...
-
Data Product Manager
4 days ago
New York, United States People Data Labs Full timeJob DescriptionJob DescriptionAbout UsAt People Data Labs (PDL), we do the heavy lifting of data collection and standardization so our customers can focus on building and scaling innovative, compliant data solutions. Our sole focus is on building the best data available by integrating thousands of compliantly sourced datasets into a single,...
-
Director Data
6 days ago
New York, United States Gain Theory Full timeAbout Gain TheoryGain Theory is part of WPP, a creative transformation company that uses the power of creativity to build better futures for its people, planet, clients, and communities. Gain Theory is a global marketing effectiveness consultancy, that uses data and analytics to deliver successful business outcomes for clients. Our vision is to inspire...
-
Technical Account Manager
3 weeks ago
New York, New York, United States Simon Data Full timeAbout UsSIMON Data is an enterprise customer data platform empowering marketers to create personalized data-driven experiences for their customers. Founded in 2015 by a team of successful serial entrepreneurs, we're a scrappy problem-solving company that believes in tackling big challenges with disruptive thinking and giving our customers the support they...
-
Risk Data Management Director
6 days ago
New York, United States Sumitomo Mitsui Financial Group, Inc. Full timeSMBC Group is a top-tier global financial group. Headquartered in Tokyo and with a 400-year history, SMBC Group offers a diverse range of financial services, including banking, leasing, securities, credit cards, and consumer finance. The Group has more than 130 offices and 80,000 employees worldwide in nearly 40 countries. Sumitomo Mitsui Financial Group,...
-
Person Data Management Lead
2 weeks ago
New York, New York, United States People Data Labs Full timeAbout UsWe do the heavy lifting of data collection and standardization at People Data Labs, allowing our customers to focus on building innovative data solutions. Our sole focus is on integrating thousands of compliantly sourced datasets into a single developer-friendly source of truth.This is your chance to join us at a pivotal moment as we bring on a new...
-
Financial Data Management Director
3 weeks ago
New York, New York, United States StateJobsNY Full timeJob Summary: We are seeking a highly skilled Director of Health Complaints and External Appeals to join our team at the New York State Department of Financial Services. As a member of the Consumer Assistance Unit (CAU) Management Team, you will provide daily oversight of three Units within CAU: the Health Unit, the Consumer Representative Unit, and the...
-
Managing Director of Data
5 days ago
New York, United States Excellence Community Schools Full timeJob DescriptionJob DescriptionWho We AreExcellence Community Schools (ECS) is a Charter Management Organization (CMO) supporting schools in the Bronx, NY and Stamford, CT. Our programs are based on a proven, nationally recognized model, which originated in our flagship school, the Bronx Charter School for Excellence, a National Blue Ribbon School. Our...