Interius BioTherapeutics Is Seeking a Sr. Manager, Project Management (Clinical)
Can you see yourself as part of a growing team engineering cells inside the human body for the treatment of devastating diseases? That’s what Interians are doing, right now. We are developing new methods for in vivo cell engineering at the forefront of advanced genetic therapies and medical innovation. We are a rapidly evolving organization, where those who enjoy the challenges and rewards of company-building, will thrive. As an experienced Clinical Project Manager (CPM), you will bring your 5+ years of work experience to a growing organization with increasing complexity of clinical project management needs.
As a CPM, you will work cross functionally with the Clinical Development, Regulatory, Pharmacovigilance, Quality, CMC, Legal & Finance leads to execute clinical trials on time and on budget in compliance with applicable GCP/ICH guidelines and country/local regulations. The CPM is responsible for managing the assigned clinical trials by employing effective organizational strategies and ongoing review of study metrics to ensure deliverables are met. As the successful candidate, you will embrace the broader role of a CPM in a small biotech heading towards its first IND submission, where you are not only an essential problem-solver, but also a wonderful collaborator, and a critical thinker.“We not only hire great talent, we hire good people” is how our CEO, Phil Johnson, addressed the company at a recent meeting.
“People who others like to work with.” If you like what you read and can see yourself as an Interian, please apply.
Responsibilities:
- Manage operational and execution aspects of programs of varying complexity, independently, within functional teams across R&D departments (Research, Clinical, Regulatory and Manufacturing).
- Develop, maintain and track high-level and detailed program development integrated timelines, ensuring consistency with input from functional team representatives and overall program leadership.
- Work closely with functional team members to ensure that mid-term and longer-term timelines remain aligned with the integrated program timelines and overall program plans.
- Raise potential problems / conflicts / issues with program timelines, risks, or budget to leadership and participate in the problem-solving and resolution of potential on-going program operational challenges.
- Assist in developing and managing communications (regular reporting of project timeline and spend vs. budget) to team leader, project team members and senior management.
- Prepare and maintain project update/progress reports and timeline revisions, as required.
- Support financial oversight of ongoing programs, including working closely with Finance in budget creation, reviews, accruals and forecasts.
- As part of Program Management, recommend and implement best practices (e.g., monthly dashboards for portfolio review, risk management logs, action item logs, resource planning).
- Help manage critical alliance relationships to ensure successful delivery of objectives and to seek opportunities for improvement.
- Facilitate negotiation of Letter Agreements, Change Orders and SOWs to capture agreement with Alliance Collaborators. Conduct oversight of contract management: including obligations, milestone payments, and negotiations.
- Assist in developing and maintain objectives for each specific strategic alliance to ensure we, and our partners, are fulfilling contractual obligations and exceeding expectations.
- Identify opportunities to improve internal and external collaborative business relationship process and implement solutions that result in a stronger collaboration; ensure timely and effective development and implementation of these solutions.
Qualifications:
- BS / MS Degree in Business, Life Science, engineering or related field
- 5-8 years of Life Science Project Management in Clinical Research
- Experience in small molecules, biologics, and/or vaccines required. Experience with cell and gene therapy preferred.
- Familiarity with a broad spectrum of clinical operations concepts, practices, and procedures with an understanding of the process and regulations that apply globally.
- Proficiency with project management tools: MS Project (required), Office Timeline Pro (preferred).
- Experience within clinical operations function including study and project management experience ideally in N. America, EU, and AsiaPac.
- Strong experience in vendor management and oversight of clinical studies and teams across multiple phases of development.
- Demonstrated knowledge of design and operational management of clinical studies.
- Possess a startup mindset of no job too big or too small
- Exceptional analytical and problem-solving skills
- Strong business etiquette and diplomacy
- Ability to operate in a fast paced, deadline sensitive environment
- Ability to work comfortably under pressure and adapt to changing priorities and deadlines
- Ability to think strategically with strong business judgment
- Able to operate independently
- Excellent verbal and written communication skills
Interius BioTherapeutics is a community of individuals, building together an organization celebrating an inclusive culture, guided by excellence, dignity and respect. Interius is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status or any other basis, protected by law.
