Location Greater Boston area
Role Description The Senior Director/Vice President, Program Leader will be responsible for overseeing the strategy, execution, and the progression of the Company's drug development programs from preclinical through clinical development, regulatory approval, and product launch. This role requires leadership of cross-functional teams, collaboration with internal and external stakeholders, and ensuring alignment with corporate objectives and timelines. The ideal candidate will possess deep scientific knowledge, strong strategic vision, and demonstrated experience managing complex drug development programs.
Responsibilities Program Management: Drive Program Strategy and Execution: Lead cross-functional teams across various functions (e.g., medical, bioanalytical, clinical operations, regulatory affairs, CMC, and marketing) to ensure effective progression of the drug development program; will also collaborate closely with Project Managers, as needed. Define and execute program goals, timelines, and milestones in alignment with corporate objectives. Accountable for the development plan and ensuring timely and strategic decision-making. Budget and Resource Allocation: Accountable for development and management of program budgets. Stakeholder Communication and Reporting: Communicate clearly with external partners, if applicable, to ensure programs goals and timelines are understood and progress is tracked by both parties. Maintain consistent communication with internal stakeholders, including senior leadership and project teams. Provide clear and concise program updates and performance metrics. Scientific Leadership: Integrate Scientific and Strategic Direction: Lead the integration of preclinical, clinical, and regulatory strategies, ensuring scientific discoveries are translated into clinical advancements. Clinical Trial Oversight: Collaborate with clinical teams on protocol design and execution to align with program strategy and regulatory requirements. Regulatory and Compliance Leadership: Ensure that all program activities are compliant with applicable regulations and ethical standards. Team Leadership and Collaboration: Cross-functional Team Leadership: Build and lead cross-functional core project teams, including medical, bioanalytical, clinical operations, regulatory affairs, CMC, and marketing. Foster collaboration and accountability within the team, ensuring program objectives are met. Risk Management and Mitigation: Identify and Mitigate Program Risks: Ensure identification of risks in scientific, operational, and regulatory domains and implement mitigation strategies. Lead Decision-Making Processes: Utilize data-driven insights to make informed decisions and adjust the program strategy when necessary. Commercial and Strategic Alignment: Market and Competitive Analysis: Collaborate with marketing resources to assess market needs, competitive positioning, and ensure the drug development program aligns with commercial objectives. Support Business Development: Provide expertise/input as needed during partnering discussions, review of partnering documents and filing of IP related to the program. Participate in discussions related to business development opportunities, including licensing and partnerships. Requirements Ph.D., Pharm.D., M.D., or equivalent advanced scientific degree in fields such as biology, chemistry, or related areas. Expertise in neuroscience and/or pharmacology preferred. At least 8 years of extensive drug development experience; proven experience leading drug development programs from preclinical to clinical phases, with an understanding of regulatory and commercial strategies. Demonstrated experience in managing cross-functional teams including clinical, regulatory, and commercial operations. Experience managing external vendors (CROs, CMOs) and partnerships. Experience in managing large-scale program budgets, resource allocation, and financial oversight. Knowledge & Skills Leadership and Team Building: Strong leadership skills with a proven ability to inspire and lead cross-functional teams in a matrixed environment. Strategic Thinking: Strategic and critical thinking skills, capable of integrating scientific insights with business and clinical strategies. Communication and Negotiation: Excellent written and verbal communication skills, with strong stakeholder management and negotiation capabilities. Adaptability and Problem Solving: Highly adaptable with the ability to adjust strategy based on emerging data and changing landscapes. 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, 401K 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 (AßOs) for the treatment of Alzheimer's disease (AD). Acumen's scientific founders pioneered research on AßOs, 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 AßOs. 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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