Careers at LumaBridge
LumaBridge is an oncology-focused clinical research organization (CRO). For us, science and patient well-being are the central mission.
We are looking for talented individuals who share our vision of helping advance the development of new therapeutics in the fight against cancer. If that’s you, please consider our available positions and apply below to join our team.
Current Openings
We are currently seeking a Senior Regulatory Affairs Specialist (RAS) to facilitate and participate in the preparation, writing, and review of regulatory submissions, which may include INDs, IDEs, briefing documents, responses to requests for information, orphan drug applications, breakthrough therapy designations, accelerated pathway submissions, and support of NDAs, BLAs, and PMAs. The Senior RAS will act as point of contact for regulatory submissions to federal agencies and offices, as applicable, and coordinate with cross-functional teams to define contributions to submissions and manage projects.
Qualifications:
- Bachelor’s degree required; life science and/or advanced degree preferred
- Minimum 3+ years of professional regulatory experience in CRO, consulting company, pharmaceutical, biotechnology, or device/diagnostics industry
- Experience with IND, IDE, NDA, BLA submissions
- Knowledge of federal and local regulations and policies pertaining to clinical investigations involving human subjects and ICH-GCP
- Computer proficiency, including in programs such as Microsoft Word, Excel, PowerPoint, and Teams, Adobe, and project management software tools
- Experience in eTMF database platforms
- Leadership, management, and motivational skills
- Demonstrated ability to work well in teams in a cross-functional manner
- Must be able to proactively identify potential challenges and provide solutions
- Excellent written and oral communication skills, including presentation skills
- Excellent analytical and organization skills; able to set priorities and meet deadlines
- Must be detail oriented and able to manage multiple complex, highly regulated projects simultaneously
We are currently seeking an experienced Biostatistician to lead study design and biostatistical strategies, provide input into protocols, develop and review statistical analysis plans, and author/coauthor reports, abstracts, and manuscripts. As the lead statistical support for all LumaBridge clinical trials, this role interacts and consults with clinical and project teams to ascertain their needs and develop appropriate design and statistical solutions. The Biostatistician critiques and improves study designs developed across the organization, has primary ownership for statistical support of all major projects, and actively mentors less experienced colleagues as needed. Excellent communication skills and a desire to be an active team player are a must.
Qualifications:
- MS in Biostatistics
- At least 5 years of experience with biostatistics associated with oncology clinical trials in a CRO or pharmaceutical setting
- Knowledge of FDA guidelines for in vivo therapeutics and diagnostic devices, with a particular focus on the field of oncology, and the required statistical basis for sample size estimation, sensitivity, specificity, agreement rates, and reproducibility testing required for validation and FDA clearance and approval
- Strong ability to collaborate across departments and interact with various levels in the organization
- High attention to detail, with skill in producing organized reports
- Ability to write statistical code and documentation
- Ability to work in a team-focused remote environment
- Ability to prioritize and plan work activities independently and collaboratively
- Knowledge of CDISC Data Standards: SEND, SDTM, and ADaM
- SAS programming skills required, and knowledge of R preferred
We are currently seeking an experienced Clinical Project Manager (CPM). The CPM is responsible for managing projects in adherence to all necessary regulations and guidelines, such as FDA regulations, ICH GCP, study protocols, and LumaBridge SOPs. As the primary point of contact for internal and external communications about managed projects, the CPM is responsible for producing high-quality client deliverables within established time frames and budgets. The CPM position is a home-based position.
Qualifications:
- At least 2 years of experience as a CPM with on-site monitoring experience at a CRO (required)
- Oncology experience (required)
- Bachelor’s degree in a scientific or life sciences discipline, or equivalent job experience
- Strong leadership skills, efficiency at mentoring and training, and ability to motivate and integrate teams
- Excellence in planning and organizational skills to enable effective prioritization of workload
- Solid interpersonal and problem-solving skills to enable working in a remote matrix organization
- Knowledge of relevant regulations (e.g., ICH/GCP, FDA guidelines)
We are currently seeking an experienced Clinical Trial Manager (CTM). The CTM serves as a client advocate and is responsible for all activities involved in the implementation and execution of clinical studies, including working closely with Clinical Project Managers to define project targets and adhere to contracted project scope. The CTM position is a home-based position.
Qualifications:
- At least 2 years of experience as a CTM with on-site monitoring experience at a CRO (required)
- Oncology experience (required)
- Bachelor’s degree in a scientific or life sciences discipline, or equivalent job experience
- Thorough understanding of clinical research processes
- Knowledge of relevant regulations (e.g., ICH/GCP, FDA guidelines)
- Excellence in written and verbal communication, organizational skills, interpersonal skills, and time management
Apply Now
To apply, complete the form below. If you prefer to submit your application via direct email, please identify which position you are interested in and provide your contact information and resume to hr@lumabridge.com.
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LumaBridge is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or veteran status.