Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.
We are seeking an exceptionally motivated individual to provide leadership and support to global regulatory activities to achieve Alumis’ strategic vision in obtaining worldwide approvals to market our products. The individual will represent Regulatory Affairs and work closely with cross-functional study teams and technical regulatory service providers in accordance with health authority and ICH requirements. In addition to being a key member of our project teams, she/he will provide organizational support as the company and its product development pipeline grow. This role will be reporting to the Director of Regulatory Strategy.
ESSENTIAL DUTIES & RESPONSIBILITIES
· Serve as the Regulatory Affairs representative for Phase 1 to Phase3 trials, ensuring regulatory activities are evaluated, prioritized and executed to meet global regulatory requirements.
· Serve as the Regulatory Affairs representative on assigned study teams and assure the progress of studies by addressing regulatory related queries in support of regulatory approvals.
· Lead preparation, review and submission of INDs/CTAs, amendments, review and approval of investigator document packages and manage other regulatory activities of the assigned studies as needed.
· Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while planning for Phase 1 to 3 trials.
· Interact with Contract Research Organization (CRO) Regulatory Affairs counterpart.
· Maintain awareness of current regulatory requirements and communicate requirements in support of regulatory approvals.
EDUCATION/EXPERIENCE/SKILLS:
· Bachelor’s or advanced degree in scientific discipline, with a minimum of 5 years of experience working in drug development in the biopharmaceutical industry and at least 3 years of experience in Regulatory Affairs; immunology or rare disease/ orphan drug development experience desirable.
Knowledge/Skills/Abilities:
· Direct experience with pharmaceutical global regulatory submissions and contributing to major regulatory filing(s) such as IND/CTA.
· Working knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices.
· Demonstrated experience in successfully leading assigned activities within cross-functional teams.
· Excellent verbal and written communication skills.
· Collaborative, analytical and interpretative skills that enable review and compilation of reports and other documents used in regulatory planning and submissions.
· Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others, prior management experience a plus.
· Responsibilities may require a work schedule that may include working outside of “normal” work hours, to meet business demands.
The salary range for this position is $165,000 USD to $195,000 USD annually paid hourly per contract. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.
Skills Required
- Bachelor's or advanced degree in scientific discipline
- Minimum 5 years of experience in drug development
- Minimum 3 years of experience in Regulatory Affairs
- Direct experience with global regulatory submissions
- Knowledge of FDA regulations and ICH guidance
- Experience in drug development for immunology or rare diseases is desirable
What We Do
At Alumis, our goal is to significantly improve the lives of patients by replacing broad immunosuppression with targeted therapies. We recognize that patients living with immune-mediated diseases need alternatives to currently available therapies. Despite recent advances and innovations in the treatment of immune-mediated diseases, many patients continue to suffer, cycling through currently approved therapies while looking for a solution that alleviates the debilitating impact of their disease without life-limiting side effects. Addressing the needs of these patients is why we exist. We are pioneering a precision approach that leverages insights we derive from powerful data analytics to select the right target, right molecule, right indication, right patient, and right endpoint resulting in optimized outcomes for patients. We believe that combining our insights with an integrated approach to drug development will produce the next generation of treatments to address immune dysfunction. Incubated by Foresite Labs, Alumis is led by a team of deeply experienced professionals who are devoted to transforming the lives of patients with immune-mediated diseases by developing a pipeline of transformative therapies.
