Vice President, Head of Regulatory Affairs

Indianapolis, IN, United States

Location

Greater Boston or Indianapolis area

Role Description

Acumen Pharmaceuticals is seeking an experienced and dynamic Vice President, Head of Regulatory Affairs to lead our regulatory strategy and ensure the successful development and commercialization of our Alzheimer's disease therapies. Reporting to the Chief Development Officer, the successful candidate will be responsible for shaping the regulatory roadmap, interfacing with regulatory agencies, and driving the regulatory approval process for our pipeline products.

Responsibilities

Develop, lead, and drive comprehensive global regulatory strategies and execution for the company's Alzheimer's disease portfolio, encompassing preclinical, clinical, and commercial phases.

Serve as the primary point of contact for interactions with regulatory authorities, including FDA, EMA, and other agencies worldwide.

Serve as a key member of the Acumen Executive Leadership Team; provide strategic guidance and leadership to cross-functional teams, ensuring alignment of regulatory activities with overall business goals.

Lead the planning, preparation, and submission of regulatory documents, including INDs, NDAs, BLAs, MAAs, DSURs, requests for expedited programs (e.g., Fast Track, Priority Review), responses to regulatory requests, and other relevant filings, while ensuring compliance with regulatory requirements.

Proactively identify potential regulatory risks and implement appropriate regulatory mitigation strategies to support the development plan, submissions, and lifecycle management.

Stay up to date with evolving regulatory guidelines, requirements, and industry trends to proactively address potential challenges and opportunities.

Advise on clinical study design and protocol development based on regulatory precedence and interactions with regulators and thought leaders in Alzheimer’s disease clinical research and drug development.

Lead interactions with regulators (e.g., pre-IND, EOP2, pre-BLA, EU scientific advice), including strategy, document preparation, meeting preparation, negotiations, and interpretation of regulator feedback.

Oversee development and implementation of regulatory policies, procedures, and best practices to ensure consistent and compliant approaches.

Collaborate with internal teams, including Clinical Development, R&D, Quality, and Commercial, to ensure regulatory compliance and alignment with regulatory strategy for product development.

Conduct regulatory due diligence activities.

Review and approve public communications (e.g., press releases, scientific publications, regulatory/clinical portions of SEC filings).

Engage with external partners, consultants, and CROs to enhance regulatory strategy and execution.

Build and lead a team of regulatory professionals, providing mentorship, guidance, and fostering a culture of excellence.

Qualifications

Advanced degree in a relevant scientific discipline (Ph.D., Pharm.D., or equivalent).

A minimum of 10 years of experience in regulatory affairs within the biotech or pharmaceutical industry, with a demonstrated track record of successfully leading regulatory activities for innovative therapies.

Extensive experience with regulatory submissions, interactions, and approvals, including interactions with FDA and other global regulatory agencies.

CNS experience required; preference for Alzheimer’s disease/neurodegenerative disease experience.

Proven ability to provide strategic leadership, manage cross-functional teams, and navigate complex regulatory landscapes.

Strong communication skills, both written and verbal, with the ability to effectively influence internal and external stakeholders.

Regulatory affairs certification (RAC) is desirable but not mandatory.

Ability to travel up to 10%.

Compensation and Benefits

Competitive base salary, eligibility for an annual incentive bonus and eligibility to participate in company stock option plan.  Competitive benefits package including health, dental, vision, life insurance, short and long-term disability, 401(k) and paid time off.

About Acumen Pharmaceuticals

Acumen, headquartered in Newton, MA, with offices in Indianapolis, IN and Charlottesville, VA,  is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AβOs. Acumen is currently conducting the ALTITUDE-AD study, a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial currently enrolling at sites in the United States and Canada, with plans for additional study centers in Europe and the UK, following positive results in INTERCEPT-AD, a Phase 1 clinical trial involving early Alzheimer’s disease patients.

Equal Employment Opportunity

Acumen Pharmaceuticals provides equal employment opportunities to all employees and applicants without regard to race, color, religious creed, sex, national origin, ancestry, citizenship status, pregnancy, childbirth, (or related medical conditions, including, but not limited to lactation), physical disability, mental and/or intellectual disability, age, military status or status as a Vietnam-era or special disabled veteran, marital status, registered domestic partner or civil union status, gender (including sex stereotyping and gender identity or expression), medical condition (including, but not limited to, cancer related or HIV/AIDS related), genetic information, sexual orientation or any other characteristic protected by applicable federal, state and local law.

Accommodation Of Disabilities

Acumen Pharmaceuticals is committed to providing reasonable accommodation for qualified applicants and employees with a disability (including veterans with a disability), unless such accommodation would cause an undue hardship.

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