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 a highly skilled and experienced Director of Safety Operations to lead and oversee the safety operation activities. This position will be pivotal in managing safety CRO, ensuring seamless and effective safety operation processes, and build safety operation systems to support regulatory filing activities.
Key Responsibilities:
· Lead and manage the drug safety operations team, providing strategic direction and oversight.
· Develop and implement drug safety policies, procedures, and systems to ensure compliance with global regulatory requirements.
· Oversee the collection, assessment, and timely submission of adverse events and safety data to regulatory authorities
· Manage safety vendor including budget, contract and resource allocations, monitor vendor performance and quality KPI
· Lead the development and maintenance of PSMF and PV QMS to support global regulatory submissions
· Lead PV inspection and audit readiness activities, act as the point of contact for regulatory inspections
· Collaborate with cross-functional teams, including clinical development, regulatory affairs, and quality assurance, to support drug safety activities for ongoing studies
Qualifications:
· Education: Advanced degree in life science, pharmacy or related field is preferred.
· Experience: Minimum of 8-10 years of experience in safety operations in the biotech or pharmaceutical industry, with at least 5 years in a leadership role.
Skills & Competencies:
• Extensive knowledge of pharmacovigilance regulations and guidelines, e.g. FDA, EMA, ICH, and other global regulations and guidelines
• Expertise in adverse event reporting, vendor and performance management.
• Proficiency with safety operation systems and tools (e.g., Safety database, MedDRA).
• Experienced in global submission
• Experienced in regulatory inspection
• Excellent communication and interpersonal skills.
• Strong leadership, strategic thinking, and decision-making skills.
• Proven track record of successfully managing drug safety operations in a biotechnology or pharmaceutical company.
• Ability to prioritize and manage multiple tasks in a fast-paced, dynamic environment.
Desired Attributes:
• Strong problem-solving and critical-thinking skills.
• Collaborative mindset with a focus on patient safety and regulatory compliance.
• Ability to work independently while leading a team and collaborating across departments.
• Passion for advancing biotechnological innovations to improve patient outcomes.
The salary range for this position is $240,000 USD to $259,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.
This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday.* At this time we are not considering remote applicants.
Alumis Inc. is an equal opportunity employer.
Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.
Other benefits include:
- Health insurance premiums paid at 90% for employee, 80% for dependents
- Free access to Genentech Bus & Ferry Share program
- $100 monthly cell phone stipend
- Unlimited PTO for Exempt employees
- Free onsite gym and a kitchen stocked with yummy snacks and drinks!
We are a hard-working, collaborative team on a mission to transform patient’s lives-- and we aspire to elevate, challenge and nurture one another along the way.
*Lab personnel are generally onsite 4-5 days/week.
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.
