Hybrid Senior Project Manager bei GEMMABio

GEMMABio is a therapeutics company focused on speeding the research of and global access to life-changing advanced therapies for those living with rare diseases. The company will provide research and product development functions to bring gene therapy discoveries from the bench to the bedside faster and affordably.

GEMMABio is led by gene therapy industry pioneer Jim Wilson and his team of experts, who previously conducted their work in academia. Wilson is also the Chairperson of Franklin Biolabs, a Contract Research Organization. The collective goal of the two affiliated companies is to translate innovative scientific work into clinical trials, to then commercialize and distribute the new therapies around the world to patients who need them most.

Job Summary

Gemma Biotherapeutics is seeking a Senior Project Manager to serve us on a 3 month contract. The position reports to the COO with responsibility for leading clinical programs with a critical role in delivering high-quality clinical results across multiple indications in the field of Gene Therapy. The candidate will manage a Project Management team to guide project team activities to meet GEMMABio’s Portfolio objectives for preclinical and clinical stage assets focused on gene therapies for rare diseases.

Duties:

• Collaborate with Executive & Management team to enable strategy and execution of Gemma’s lead assets; ensure working group meetings are agenda-focused to enable efficient decision-making.
• Collaborate with R&D (Preclinical, Clinical, Regulatory, QA, and CMC) Teams to define and manage deliverables and timelines, facilitate decision making, and define risk mitigation strategies/contingencies for the Asset Development Plan.
• Build, maintain and control the cross functional timeline for the execution of the Development Plan to BLA/MAA filing; highlighting dependencies, milestones, deliverables, and critical path and ensure cross-functional teams are tracking to timeline milestones.
• Play a cross functional leadership role in identifying, designing and implementing strategic initiatives that impact the program(s).
• Leads and facilitates meetings at all levels of the organization to ensure cross alignment to corporate strategy and to manage execution of plans to meet objectives while adhering to timelines and budget.
• May lead one or more external preclinical stage sponsored research project.
• Portfolio management: manage program and project prioritization with the ED-Portfolio Management and the leadership team.
• Works with R&D and CMC Leadership to align processes for effective meeting management and driving team member accountability across teams.
• Works with Contracts and Alliance Management team to ensure agreements are completed on time and meet the Sponsor and/or R&D Teams’ specifications.
• Collaborate with PM team leadership in the development and tracking of Key Performance Indicators (KPIs).

Qualifications:

• Bachelor's Degree in a life sciences or molecular biology. (Master's degree desired)
• PMP or PMI certification beneficial but not required
• 5-7 years of applicable experience in program management is required.
• Must have experience in clinical trails (Phase 1 preferred)
• Experience focused on clinical assets for rare diseases with hands on experience in filing a BLA with the FDA is beneficial
• Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies is beneficial.
• Ability to perform well under pressure and embrace dynamic environment.
• Strong analytical and critical thinking skills required