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Associate Director/Director, Drug Safety
1 month ago
Location
Greater Boston area
Role Description
Acumen Pharmaceuticals is seeking an Associate Director/Director, Drug Safety & Pharmacovigilance (PV), reporting to the Vice President, Drug Safety & Pharmacovigilance. Job title will be determined based upon prior experience and skills. The Associate Director/Director, Drug Safety & Pharmacovigilance will support a wide range of activities within Drug Safety & Pharmacovigilance (DS&PV). In addition, this role is responsible for safety surveillance, risk management, and risk communication for assigned products, leading and participating in Safety Review Team (SRT) meetings and developing aggregate reports and other safety documents.
Responsibilities
- Perform ongoing review of emerging safety data from various sources including single case reports, aggregate reports, clinical trial data, literature, and other sources.
- Ensure that routine signal detection, assessment, and evaluation is completed and documented in a timely manner.
- Coordinate, plan, and prepare aggregate reports (e.g., DSUR) and other safety related regulatory documents (e.g., RMP).
- Attend product Safety Review Team (SRT) meetings and support SRT related activities (e.g., scheduling, preparing meeting minutes).
- Provide expert safety input to the clinical development program.
- Support operations and compliance activities (e.g., SMP, SDEA) within DS&PV.
- Manages PV vendors on PV and risk management
- Liaise effectively with key stakeholders and business partners.
- Bachelor's degree in biological or health-care discipline required (e.g., RN); advanced degree in a related field is a plus (e.g., RPh, PharmD, etc.).
- At least 5-8 years of experience in pharmaceutical industry within Drug Safety & Pharmacovigilance with both investigational and marketed products.
- At least 3 years of experience with aggregate reporting, safety surveillance, signal management and/or risk management.
- Previous experience in Neurodegenerative therapeutic area preferred.
- Expertise in international regulations governing drug safety (e.g., FDA, EMA).
- Thorough understanding of the drug development process and context applicable to safety surveillance activities.
- Excellent verbal and written communication and interpersonal skills.
- Ability to identify and resolve problems in a timely manner.
- Ability to manage multiple projects simultaneously while adhering to strict deadlines.
- Demonstrated accountability and a sense of urgency for both individual and team-owned projects.
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.
