New

Senior Director, Legal & Compliance

South San Francisco

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. 

About the Role:

We are seeking an exceptionally motivated attorney to further evolve Alumis’ global healthcare compliance strategy and to provide day-to-day legal support for our medical affairs and commercial teams. This is a key position on our legal and compliance team. In this role you will work cross-functionally to set policies and be primarily responsible for ensuring compliance across several business units. You will be a crucial contributor to Alumis’ strategic vision to continue our development efforts and ultimately obtain regulatory approval in several global markets. You will report to our Senior Vice President, Legal.

 

Key Duties & Responsibilities

· Develop and implement compliance program goals, policies, trainings and strategy in alignment with applicable laws, industry standards and the Company’s ethics and compliance program

· Serve as key legal partner to Commercial (Sales, Marketing, Market Access), Medical Affairs, Quality and Regulatory business units

· Deliver meaningful and effective counseling in order to facilitate the progress of our development programs and the buildout of our commercial function, with expert understanding of:

  • Anti-bribery/anti-corruption laws (e.g., Foreign Corrupt Practices Act (FCPA))
  • Federal Food, Drug and Cosmetic Act (FD&C) and FDA regulations
  • False Claims Act (FCA), Anti-Kickback Statute (AKS)
  • Federal Sunshine Act and relevant state transparency/aggregate spend laws
  • OIG and other guidance and laws relating to compliance programs and interactions with Health Care Professionals (HCPs);
  • GDPR, CCPA/CPRA and other state privacy laws; and
  • Other relevant federal and state laws governing compliance.

· Support legal needs of Clinical Development

· Manage our non-clinical development contracting function, including effectively leading a small but mighty legal team drafting and negotiating contracts, templates and playbooks to support multiple business units

· Conduct regular risk assessments; identify new and emerging risks and respond with a solution-oriented risk posture, calibrated to business needs and growth imperatives

· Advise on appropriate compliance interactions and policy guidelines, including on topics such as advisory board participation, speaker programs, fair market value, and grants and corporate contributions

· Support the Company’s privacy program, including developing and implementing phase-appropriate policies and procedures

· Serve as principal legal lead for material reviews and conference preparation

· Support Quality audits and oversee/investigate compliance-related incidents and breaches

· As applicable, oversee and manage the process and capture of timely, accurate and consistent data for incorporation into filings and reports related to required HCP payment disclosure, including U.S. Sunshine Act, state law reporting and comparable international pay transparency laws.

· Serve as legal lead for managing, maintaining, documenting, and dispatching of all Legal & Compliance-training materials, policies, or content (including new hire Legal & Compliance trainings) and other Learning Management System (LMS) project management areas

· Monitor changes in relevant law, regulations and industry standards, and engage in continuous improvement to review and update compliance program accordingly.

 

Required Skills/Experience

· Law degree from an accredited U.S. law school

· Admission to practice law in one or more U.S. states. If not admitted in California, valid RIHC.

· Minimum of 8-10 years of relevant legal & compliance experience in pharmaceutical/biotech space, with demonstrated and progressive experience and leadership

· Expert knowledge of applicable laws, regulations and industry practices relevant to role

· Experienced in developing and implementing healthcare compliance policies and trainings; driving such initiatives with a sense of urgency

· Exceptional relationship-building skills; must be a team-player and maintain collaborative working relationships across multiple functions and levels of management

· Solution-oriented and excellent analytical skills; demonstrating risk-awareness and sound judgment on matters of compliance and ethics

· Demonstrated experience in drafting and negotiating contracts to support multiple business units, including medical affairs and commercial

· Well-organized and detail-oriented, with the ability to manage numerous projects simultaneously under deadline pressure in a fast-paced, dynamic organization

· Self-motivated and willing to take initiative; with high level of intellectual, professional and interpersonal curiosity, agility and flexibility

· Strong presentation, verbal, and written skills, with advanced proficiency in MS Office Suite and any presentation tools (e.g., PowerPoint).

 

Nice-to-Have Skills/Experience

· Experience supporting other business units within a lean legal infrastructure (e.g., Development, Quality, legal operations)

· Prior law firm experience

· Prior public company experience

 

 

The salary range for this position is $305,000 - $325,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company’s compensation practices.

Hybrid work model, which allows for work to be completed from home and in the office. 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 patients’ lives-- and we aspire to elevate, challenge and nurture one another along the way.

 

 

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