Over one million people in the world today are fighting blood cancer. While a traditionalallogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.

Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects. The first application of Orca Bio’s platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.

The Program Manager/Director will be responsible for providing program level management support to effectively oversee, direct, and plan all major regulatory submission (BLA/MAA) and quality inspection deliverables. This position will work cross-functionally with CMC, manufacturing operations, quality, clinical development, medical writing, and safety to efficiently track progress against all regulatory timelines and deliverables. The successful candidate will be experienced in program management with core regulatory filing experience, with a proven track record of succeeding in a multidisciplinary, collaborative, and fast paced start-up environment.

Required Qualifications

· Comprehensive understanding of the drug development space within the biopharmaceutical industry with 10+ years of experience

· 5-7+ years’ experience in either project and program management supporting investigational products throughout the commercialization lifecycle, including early and late-stage clinical development

· Bachelor’s degree

· Understanding of cross functional dependencies that can impact marketing authorization and inspection readiness deliverables

· Experience providing project or program management support for IND/CTA

· Skilled at translating cross functional deliverables from regulatory, clinical, quality, CMC and manufacturing operations into effective implementation plans and strategies to meet strategic and corporate goals

· Experience using risk management and mitigation driven tools to track development activities and identify critical path items for key regulatory and quality deliverables while managing and maintaining aggressive regulatory timelines

· Comfortable challenging the status quo and bringing forward innovative solutions

· Ability to see and understand broader, enterprise level perspective for regulatory and quality level milestones

· Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging

· Excellent interpersonal and negotiation skills

· Demonstrates strong ability to collaborate, interact and work effectively with other departments as well as external organizations and vendors

· Ability to apply scientific principles to assess issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions

· Analytical and problem-solving skills with the ability to identify issues and opportunities and provide direction to teams to explore alternatives

· Expert with Microsoft Project (MPP), SmartSheet, Visio, Excel and Powerpoint

Preferred Qualifications

· Project Management certification, e.g. PMP

· Cell or gene therapy experience

· Experience with BLA/MAA, PAI/BIMO inspection readiness activities

Responsibilities

· Partners with the cross functional BLA filing and inspection readiness team(s) to ensure regulatory and inspection readiness timelines are established and maintained in alignment with corporate goals

· Supports regulatory and quality lead(s) in delivering successful submissions/filings, inspections with global regulatory authorities for allogeneic cell therapies using effective program management leadership, implementation of oversight, direction, and planning

· Utilizes project management tools to generate and deliver customized reports, dashboards, and metrics to enable actionable insights assuring successful outcomes for regulatory and quality milestones (BLA, MAA, PAI, BIMO inspections)

· Partners with regulatory operations to ensure that regulatory publishing and submission plans for BLA are aligned.

· Uses project management tools to identify critical path issues, develop risk-based issue resolution and mitigation strategies to enable solutions to support decision-making.

· Coordinate with regulatory and quality teams to ensure applicable outsourced third party vendors meet all program timelines and company standards.

· Drive decision making processes and escalate issues, as needed, ensuring proactive planning is taking place to enable delivery of applicable project-level milestones

· Actively contribute to the development, implementation and continuous improvement of PM tools and processes across Orca Bio.

· Maintain lessons learned log for major regulatory milestones (BLA/MAA) and quality milestones (PAI, BIMO); track project variances and identify root causes; detect, raise awareness, and develop plan to address systemic concerns/issues

· Demonstrate ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all patients who need them.

We strive to do things right, and to embody our core values of passion, courage, and integrity. Excellence in our work means the potential to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate daily on a path that hasn’t been paved. This means we lean heavily on our entrepreneurial spirit and are comfortable taking calculated risks to achieve progress toward our mission. It means we aren’t afraid to ask “why not,” and encourage lively discourse around rethinking the status quo.

We work hard to preserve our start-up culture rooted in camaraderie and leadership by example - by everyone, regardless of title.

We’re proud to be an equal opportunity employer, and have seen how our differences - when celebrated and woven together - create stronger and more lasting solutions that better serve our team, our partners, and most importantly, our patients and the providers who treat them.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent department, and all candidates are presented through this channel only. We do not accept unsolicited resumes.

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