You haven't searched anything yet.
Director/Sr. Director, Regulatory Affairs
About Immuneering
Immuneering (Nasdaq: IMRX) is a clinical-stage oncology company developing medicines for broad populations of cancer patients. Our initial aim is to develop a universal-RAS therapy, an approach designed to include patients with solid tumors driven by any mutation in KRAS, NRAS, or HRAS. Our inclusive approach differentiates us from narrowly targeted precision therapies, which are limited to patients with tumors harboring select mutations. We are currently evaluating our lead product candidate, IMM-1-104, in a Phase 1/2a clinical trial in patients with advanced solid tumors harboring RAS mutations. IMM-1-104 is being developed as a once-daily oral monotherapy that aims to achieve universal-RAS activity through deep cyclic inhibition of the MAPK pathway. Deep cyclic inhibition is a novel mechanism that aims to deprive tumor cells of the sustained proliferative signaling required for rapid growth, while sparing healthy cells through a cadenced, normalized level of signaling. This mechanism was engineered using our proprietary informatics-based discovery platform. The development of our pipeline is translationally guided by our proprietary, human-aligned 3D tumor modeling platform that we combine with bioinformatics-driven patient profiling, which we believe has the potential to increase the probability of success in clinical development versus traditional drug development approaches. Our second product candidate, IMM-6-415, aims to achieve universal-MAPK activity with an accelerated twice-daily oral dosing cadence, also through deep cyclic inhibition of the MAPK pathway. IMM-6-415 is currently in IND-enabling studies. Our pipeline also includes Trifecta MEK, RAS modulators, and other small molecule drug discovery programs.
Immuneering’s R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge, MA. Immuneering has grown to more than 75 employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering’s team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development.
General Summary of Duties:
Be an integral part of Immunering by spearheading, growing and developing robust regulatory processes and procedures. Join a diverse and collaborative group and make a deep impact of moving science forward in a fun, hybrid work environment which celebrates innovative thinking and where your input will be respected and sought out as an expert in your field.
The position involves providing the content for our regulatory strategy within an oncology focused company. Provide significant input into comprehensive regulatory strategy documents. Develop and execute company-wide regulatory priorities and be part of working on the quality systems. Engage and manage external relationships including interaction with FDA representatives regarding product and project issues. Promote and develop initiatives to continually improve working relationships within and across departments.
Be an active and highly participatory member of cross functional teams. Act as an advisor t6 internal colleagues and leaders to meet schedules and resolve situations proactively when working with regulatory bodies, such as the FDA. Provides input into development of regulatory strategies. Works with other colleagues within Immuneering’s labs, discovery and translational teams, clinical, legal and business development.
A successful incumbent will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player who embraces our mission, vision and values.
Specific Duties, may include but not be limited to the following:
Desired Skills and Qualifications
Physical Demands/ Working Conditions
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role.
Full Time
Scientific Services
$148k-195k (estimate)
03/26/2023
07/22/2023
immuneering.com
KENDALL SQUARE, MA
25 - 50
2008
BENJAMIN ZESKIND
<$5M
Scientific Services
The job skills required for Director, Regulatory Affairs include Regulatory Affairs, Initiative, Product Development, Clinical Trial, Project Management, Drug Development, etc. Having related job skills and expertise will give you an advantage when applying to be a Director, Regulatory Affairs. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Director, Regulatory Affairs. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Director, Regulatory Affairs positions, which can be used as a reference in future career path planning. As a Director, Regulatory Affairs, it can be promoted into senior positions as a Top Regulatory Affairs Executive that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Director, Regulatory Affairs. You can explore the career advancement for a Director, Regulatory Affairs below and select your interested title to get hiring information.