Contract Development Program Manager

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.

We are seeking a highly motivated and versatile individual to join our team as a Program Manager for a 3-6 month contract. In this role, you will play a pivotal part in our Development Core Team, facilitating effective communication, driving project deliverables, and contributing to various cross-functional projects in areas such as CMC, Regulatory, Clinical, Medical Affairs, Patient Advocacy, and Non-Clinical. This is a unique opportunity to work at the intersection of genomics and therapeutics, and to participate in the development of a diverse therapeutic pipeline driven by a transformative core technology.

The successful candidate will work closely with both internal groups and select external organizations. This position requires a highly motivated self-starter with a strong program management and technical background who can assimilate new information quickly. This individual will report to the Chief Medical Officer and will help identify and implement tools and processes to facilitate successful delivery of Encoded’s research and development programs.

Requirements

Provide programmatic support that may include but not be limited to the following activities:

• Serve as the primary PM for a clinical development program, including the development and maintenance of strategic plans and timelines.
• Maintain program status tools (e.g. dashboards, timelines, logs, etc.).
• Organize Development Core Team activities that facilitate cross-functional collaboration, foster effective communication and strategic discussions, and ensure all stakeholders are aligned on program objectives and milestones to aid decision-making.
• Support cross-functional teams in planning, development and maintenance of timelines, and execution on the clinical development of gene therapy programs. Partner with specific functions to manage operational aspects of plan implementation and execution.
• Understand product development under GCP, SOPs, and Regulatory requirements, as well as Commercialization considerations.
• Ensure cross-functional teams are properly prepared for internal meetings, communications to management and engagement with external partners.

Program Management:

• Facilitate program planning, including development of integrated project plans, timelines, and assisting functional leads with resource allocation to achieve program goals.
• Drive deliverables resulting from Core Team meetings, ensuring cross-program priorities and timelines are met. Ensure alignment with the Development Steering Committee and Leadership Team.
• Partner with functional leads to coordinate cross-functional projects related to CMC, Regulatory, Clinical, Medical Affairs, Patient Advocacy and Non-Clinical, providing support and guidance to achieve project goals.
• Assist functional leads with implementing risk management strategies, proactively identifying and mitigating program risks and challenges.
• Optimize and improve existing PM tools.

Communication and Reporting:

• Maintain effective communication channels within Development Core Teams, the Medical Office, and across functions.
• Monitor and report program progress, providing regular updates to cross-functional teams, the Development Steering Committee, senior leadership, and other stakeholders, highlighting key achievements, risks, challenges, and mitigation plans.
• Utilize formal communication protocols and tools including dashboards, reports, weekly/monthly updates, and any other specific information as needed for internal use to help achieve company and operational goals.

Ad Hoc Projects:

• Demonstrate flexibility and adaptability to contribute to ad hoc functional projects across various departments.
• Collaborate with team members to address challenges and find innovative solutions for ad-hoc projects, as needed.
• Support Medical Office preparation for quarterly business review (QBR) and board of director (BoD) meetings.
• Support budget reviews as needed.

Qualifications:

• Advanced degree in life sciences, pharmacology, or a related field; an MBA or project management certification is a plus.
• Experience (2+ years) in program management within the biopharmaceutical industry, with a focus on gene therapy, AAV vectors, or rare diseases.
• Proven track record of successfully leading and managing cross-functional teams in the development and execution of complex development programs, preferably in the field of gene therapy.
• Strong understanding of drug development processes, including preclinical, clinical, regulatory, and commercial requirements.

Skills and Attributes:

• Self-starter with the ability to work independently and take initiative.
• Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively at all levels of the organization.
• Strategic thinker with the ability to prioritize and make informed decisions in a fast-paced environment.
• Strong problem-solving abilities and a proactive approach to identifying and resolving issues.
• Willingness to learn and collaborate in a dynamic team environment.
• Excellent written and oral communication skills
• Proficient utilizing MS Office Suite, SmartSheet, and/or other Project Management tools and software.