Senior Project Manager, CMC Project Management

About TrialSpark

TrialSpark is a technology-driven drug development company that runs end-to-end clinical trials, focused on bringing new treatments to patients faster and more efficiently.

The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $1B+. To combat this industry problem, TrialSpark is building a technology platform that optimizes all aspects of a clinical trial, enabling more efficient trial design, faster trial completion, and higher trial data quality.

TrialSpark recently raised their Series C, and is putting the capital to work by in-licensing and co-developing drug programs through in-house development, joint ventures, and NewCos. Together with doctors, patients, and communities, TrialSpark is working to develop the treatments of tomorrow.

About The Role

Reporting to the Vice President, Program Management, TrialSpark is seeking a highly motivated Sr  Manager / Associate Director, CMC Project Management to drive the delivery of pipeline assets and technical projects. The candidate will work collaboratively with the CMC team and functional leads to guide the preparation and implementation of strategic and tactical plans that support the advancement of development and manufacturing from product acquisition, through development and into registration and commercialization, in alignment with the overall project plan and milestone deliverables. This includes, but is not limited to, process development, analytical development, technical transfer, cGMP documentation, regulatory documentation and project strategy. 

Responsibilities

• Co-leads CMC team meetings alongside technical CMC Lead applying project management expertise and facilitating productive team discussions across multiple CMC program(s).
• Partner with project and work stream leads providing leadership to successfully achieve project objectives inclusive of program assets as well as strategic initiatives.
• Regularly interacts with functional areas beyond CMC, such as Regulatory, Quality, Supply Chain, Technical Operations and Clinical Development
• Regularly meets with CMC management and SMEs to review recent results, set next plans, and ensure appropriate progress is being made on assigned programs.
• Documents project progress by capturing key discussions, communications and decisions in meeting notes that are distributed and reviewed by the team on a regular basis. Establishes, maintains and is accountable for project timelines and associated CMC plans
• Ensures effective coordination of activities and deliverables across CMC functions ensuring integration with overall program plan
• Manages partner and CDMO relationships ensuring clear communication and accountability
• Estimates and manages material needs (DS, DP, etc.), quantity and timing for all development activities
• Proactively anticipates obstacles or risks to CMC deliverables and coordinates the development and implementation of appropriate mitigation strategies. Identifies and escalates issues when programs or projects timelines and deliverables are at risk
• Conducts scenario planning to proactively provide analysis and recommendations on alternative development plans, along with the associated assumptions and risks

About You 

• Accredited bachelor’s degree or equivalent with 7+ years’ experience in bio tech/pharma CMC project management
• Strong knowledge of biopharma industry and technical knowledge with end-to-end CMC biologics and/or small molecule development.
• Communicates clearly and precisely in both written and verbal communications with internal and external partners at all levels of the organization
• Strong leadership skills with the ability to lead difficult discussions and positively influence outcomes.
• Ability to work both independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members; maintaining strong business partner relationships
• Proficiency with related software tools such as: MS Project, SmartSheet, MS PPT, MS Excel, etc.
• Results oriented, has a bias for action. Strong initiative, accountability and willingness to take ownership and drive projects to completion.
• Accustomed “roll up their sleeves” and execute the tasks needed in a small company environment.
• Remote work location with occasional office presence required.
• Up to 20% travel to contract organizations within the US and to UK/Europe required.

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.