Vice President, Regulatory Affairs (Remote)

Position will be based remotely but have access to to NY, Cambridge or San Diego offices as needed. 

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 managing the regulatory function and processes and providing the content for our regulatory strategy within an oncology focused company. Provide significant leadership for a comprehensive regulatory strategy. 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 leader and be a highly participatory member of multiple cross functional teams.  Act as an advisor to internal colleagues and leaders to meet schedules and resolve situations proactively when working  with regulatory bodies, such as the FDA.  Provides leadership and direction in the 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:

• Manage and engage in building strong working relationships within the FDA and other, global, regulatory agencies. 
• Champion Immuneering projects and products; proactively present programs, discuss and resolve issues, and support obtaining prompt approvals. 
• Proactively make recommendations on overall strategy and timelines, make required changes to company strategy related to filings and approvals.  Manage all the activities involved with running a successful regulatory function.
• Be a hands on and strategic leader, be eager to roll up your sleeves and perform work at all levels as expected in a biotech environment.
• Serve as regulatory leader on critical company issues with FDA and other bodies.
• Direct negotiations and facilitate interactions with regulatory agencies and corporate groups regarding regulatory responsibilities.
• FDA liaison for all project issues 
• FDA liaison on critical company issues.
• Lead FDA and other external regulatory meetings.
• Lead major label negotiations.
• Product Development and Support, including Target Product Profile development
• Provide for training and dissemination of information as necessary for Regulatory Affairs or other departments .
• Responsible for creation and oversight of regulatory submissions.
• Approve specified regulatory submissions.
• Perform or supervise regulatory review of all documents for submissions; e.g., clinical protocols and study reports; preclinical reports; chemistry, manufacturing and control reports, investigator brochures, application summary documents.
• Plan regulatory submission strategies to best utilize resources.
• Provide training to the regulatory staff, as needed.
• Implement new FDA or global regulations and guidelines for assigned products/projects.
• Responsible for development of regulatory submission strategies.

Desired Skills and Qualifications

• A Bachelor’s degree is required/ an advanced degree (PhD, PharmD or other advanced degree) highly preferred; Life Science degree preferred.
• Minimum of 8-10 + years total pharmaceutical/FDA/regulatory related industry experience leadership required/ International regulatory experience is preferred.
• Regulatory project management experience required inclusive of regulatory filings and approvals (IND, NDA, BLA, etc.)
• Proven ability to develop robust regulatory strategies required.
• International CTA filing experience is helpful and experience working on the CRO side of the business is a plus.
• Experience and knowledge of the current requirements of FDA and major international regulatory bodies.
• The ability to establish congenial and productive working relationships.
• Exceptional communication skills, both written and verbal, regulatory writing skills are paramount.
• Capability to manage multiple workflows within a single day.
• Ability to effectively work within cross-disciplinary teams.
• Must be a self-starter, proactive, motivated, ambitious, scientifically curious, and collaborative.

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.