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Lead Program Manager

2 months ago

New Bedford, Massachusetts, United States Ocular Therapeutix Full time

Ocular Therapeutix is in search of a dedicated and experienced Senior Program Manager/Associate Director to enhance its Program Management team, concentrating on clinical and strategic alliance initiatives. This role is pivotal in steering core and sub-team projects, ensuring they align with the overarching corporate goals.

The Senior Program Manager/Associate Director will oversee intricate, cross-functional projects, ensuring timely and scope-compliant delivery. This position demands strategic insight and robust leadership to harmonize efforts across R&D, technical operations, regulatory affairs, clinical operations & development, medical collaborations, and commercial teams. A profound comprehension of the pharmaceutical development lifecycle, from initial discovery to market launch, alongside the ability to navigate regulatory frameworks and industry standards, is crucial.

The ideal candidate will exhibit exceptional team-building capabilities, effective communication, receptiveness to diverse viewpoints, and a talent for fostering collaboration and alignment.

Key Responsibilities:

Project Leadership: Direct core and/or sub-teams composed of seasoned subject matter experts to formulate and document integrated program strategies, including both long-term and short-term timelines that align with the organization’s strategic objectives. Facilitate and lead meetings, ensuring comprehensive documentation of minutes, action items, and decisions. Collaborate with team members to develop and deliver engaging, audience-focused presentations for the program/core team and other stakeholders, including the Senior Leadership Team.Strategic Planning: Create and sustain detailed project plans encompassing timelines, budgets, resource distribution, and risk management strategies.Stakeholder Management: Serve as the primary liaison for project stakeholders.Risk Management: Identify potential project risks and devise mitigation strategies. Ensure contingency plans are established and adjust project plans as necessary to address emerging challenges.Regulatory Compliance: Partner with the regulatory affairs department to guarantee that all project activities adhere to relevant regulatory standards, including FDA, EMA, and ICH guidelines. Coordinate the preparation and submission of regulatory documentation.Performance Monitoring: Monitor project advancement against milestones and objectives. Provide regular updates to program/core teams and modify plans as needed to ensure project success.Team Leadership: Cultivate a collaborative and results-oriented atmosphere within the core and sub-teams. Address conflicts and offer guidance to ensure team cohesion. Consistently exemplify and promote psychological safety through your actions.Vendor Management: Supervise the management of external vendors in collaboration with stakeholders as necessary, ensuring that services are delivered punctually, within budget, and to the required quality standards.Continuous Improvement: Propel process enhancements within the project management function, identifying opportunities to boost efficiency, reduce costs, and improve outcomes.

Qualifications:

Education: Bachelor’s degree in a relevant discipline (e.g., life sciences, pharmacy, engineering). A master’s degree or MBA is advantageous but not mandatory.Experience: A minimum of 7-10 years of experience in the pharmaceutical or biotech sector, with a proven history of successfully managing complex projects.Certifications: PMP (Project Management Professional) or equivalent certification is optional.Technical Skills: Strong grasp of pharmaceutical development processes, including clinical trials, regulatory submissions, and commercialization. Proficiency in project management tools (e.g., MS Project, Smartsheet).Leadership Skills: Demonstrated ability to lead cross-functional teams, manage stakeholder relationships, and drive project success in a matrixed environment.Communication Skills: Excellent written and verbal communication skills, with the ability to present complex information clearly and concisely to diverse audiences.Problem-Solving: Strong analytical and problem-solving skills, focused on delivering solutions that meet project objectives and stakeholder needs.Time Management: Capability to manage multiple priorities and projects concurrently, ensuring deadlines are met without compromising quality.This role may involve occasional travel to attend conferences or oversee project-related activities. The position may also require extended hours to meet critical project deadlines.This is a hybrid-based role.