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Acumen Pharmaceuticals - Newton, MA

posted 3 days ago

Full-time - Senior
Newton, MA
Chemical Manufacturing

About the position

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

  • 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.
  • Accountable for development and management of program budgets.
  • 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.
  • Lead the integration of preclinical, clinical, and regulatory strategies, ensuring scientific discoveries are translated into clinical advancements.
  • Collaborate with clinical teams on protocol design and execution to align with program strategy and regulatory requirements.
  • Ensure that all program activities are compliant with applicable regulations and ethical standards.
  • 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.
  • Ensure identification of risks in scientific, operational, and regulatory domains and implement mitigation strategies.
  • Utilize data-driven insights to make informed decisions and adjust the program strategy when necessary.
  • Collaborate with marketing resources to assess market needs, competitive positioning, and ensure the drug development program aligns with commercial objectives.
  • 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.

Nice-to-haves

  • Strong leadership skills with a proven ability to inspire and lead cross-functional teams in a matrixed environment.
  • Strategic and critical thinking skills, capable of integrating scientific insights with business and clinical strategies.
  • Excellent written and verbal communication skills, with strong stakeholder management and negotiation capabilities.
  • Highly adaptable with the ability to adjust strategy based on emerging data and changing landscapes.

Benefits

  • Competitive base salary
  • Eligibility for an annual incentive bonus
  • Eligibility to participate in company stock option plan
  • Competitive benefits package including health, dental, vision, life insurance, 401K and paid time off
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