Manager/Director Program Management Gene Therapy

NO PHONE CALLS OR AGENCIES PLEASE

Background

Selecta Biosciences is seeking a talented and dedicated leader to join our fast paced and growing company! Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing biologic therapies for rare and serious diseases that avoid the immune responses that compromise efficacy and lead to life-threatening complications. Selecta is applying its proprietary Synthetic Vaccine Particles (SVP™) to a range of therapeutic areas in which immunogenicity is a key challenge. Our lead program SEL-212 is in phase 2 clinical development for patients with severe forms of gout. Our two fast advancing gene therapy product candidates for inborn errors of metabolism (MMA and OTC) have the unique potential to enable repeat administration, allowing for dose adjustment in patients and maintenance of therapeutic activity over time.

Summary

The Program Manager Gene Therapy will be responsible for coordinating our internal and high caliber external development teams through the different stages of clinical development and product launch. The successful candidate will be instrumental for developing and implementing the regulatory and clinical development strategy. Interactions with all our functional stakeholders including research, clinical investigators, patient advocates, regulatory agencies, consultants and manufacturing will be key to prioritize tasks, identify and resolve bottlenecks. We are looking for a highly motivated professional with excellent interpersonal skills to ensure quality and timely execution of our programs in the growing gene therapy franchise. S/he will be responsible for managing overall project planning, cross-functional program meetings, coordination with outside parties (e.g. CRO’s), and help prepare for and participate in interactions with regulatory agencies to achieve short and long-term product development goals and ensure alignment between technical plans, commercial objectives and overall corporate objectives.

The position offers a career enhancing opportunity to lead rare disease programs from IND/ CTA filing to launch and participate in all critical steps of drug development. The new member of our team will have exposure to leading industry experts and senior management at Selecta.

Key Responsibilities

• Lead high performing internal and external cross-functional teams, focusing on both strategy and the execution of product plans.
• Broadly contribute to strategic thinking for the assigned programs
• Develop and implement project execution plans to achieve short-term and long-term goals
• Proactively identify potential risks and work with teams to develop risk mitigation plans.
• Complete critical path analyses including the evaluation of potential means to accelerate programs and to mitigate identified risks.  Manage the team to recommend revised strategies as appropriate.
• As needed develop, build and maintain productive alliance management culture addressing  development, commercial and business challenges
• Manage team meetings including the preparation of appropriate agendas and documentation of meeting minutes.
• Generate program status updates and program review communications (TPP, Clinical Development Plan, CMC/Product Development Plan).
• Create and manage an integrated timeline and corresponding budget for the program. Work with team to maintain the timeline as current and manage budgetary spends.
• Help develop a program management systems and best practices to be applied consistently across projects