Our client is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. We're currently looking for an Associate Director for the Research Operations Team at our client's new research and clinical production facility in Gaithersburg, Maryland. The facility is being developed as a Center of Excellence for the advancement of novel TCR mediated T cell therapies targeting tumor mutations and antigens.

In this role, you will support one or more Research Teams (RT) and will be responsible for supporting Research Team activities, including but not limited to:

General Project Management Responsibilities:

• Implement outstanding project management processes and tools/templates such as project timelines, Gantt charts, action/decision logs, risk registers, SharePoint site etc.

• Provide Research Teams with project management leadership and insights in research strategy and process to guide and organize the Research Team

• Define scope, build project plans, goals and achievements

• Prepare agenda, minutes, and action items for meetings

• Manage meetings, ensuring timely, efficient, and operations

• Track & report progress

• Support team members and empower them to complete deliverables efficiently and effectively

• Guide research project team through governance processes and stage gate reviews

• Liaise with cross-functional and functional partners (e.g. Program Manager, CMC Program Manager, Alliance Manager, Legal and Regulatory representatives etc.) to execute on cross-functional deliverables and resolve problems

• Direct research project communications and ensures that all partners (internally and externally) are fully informed and knowledgeable of project activities and their status

• Handle external collaboration project and all associated interactions (e.g. meetings, communications etc.) with the partners when necessary

• Lead and track non-clinical and clinical study report deliverables for IND and BLA filings

• Provide inputs on behalf of the RT for the budgeting process

• Maintain SharePoint site and documents

• Provide training and communication of Research governance process

• Support Research governance meetings if needed

• Prepare routine and/or ad hoc project status/dashboard reports

Specific Responsibilities:

• Build, execute and implement project management deliverables, organization, documentation and processes for the site

  Organizes the formation of Project Teams and with leadership of the functional areas, guides transition of projects from research into development

• Coordinates preparation of, reviews and edits governance documents, periodic project reports, budget forecasts etc.

• Participates in working groups within the site to resolve complex operational issues or improve department processes

• Along with the project lead, represents the Project Team at governance meetings for major strategic decisions

• Liaison between site leadership and Research Strategy & Operations group

Requirements:

• 10+ years of relevant experience and a BS in immunology/cell biology or related fields or; 8+ years of relevant experience and a MS in immunology/cell biology or related fields OR

• A PhD in a scientific field or a PharmD, DVM or MD degree and 4 years of relevant experience

• Must have extensive understanding of discovery research, translational sciences/medicine and pre-clinical development and overall drug development process.

• Must have extensive experience in applying principles, concepts, practices, and standards of pharmaceutical project management in Research and/or Translational Sciences/Medicine.

• Exemplify our core values – integrity, accountability, team work, excellence and inclusion.

• Must possess excellent interpersonal, organizational, written and verbal skills along with ability to work collaboratively in a team environment and effectively communicate progress toward achievements, opportunities, and risks to all partners.

• Must be able to understand and communicate scientific and business data

• Must exhibit high emotional intelligence, with demonstrated ability to successfully negotiate through challenging situations and difficult conversations.

• Possess a strong ability to build trust, along with proven ability to drive, lead and influence colleagues across the organization to achieve team, department and company goals.

• Must be a great teammate, focusing on shared goals, being flexible and applying skills where required, respecting others, listening to others’ views and value others’ contribution, sharing information and good ideas across organizations and celebrating/recognizing accomplishments.

• Must have strong leadership skills and ability to effectively develop teams and coach others.

• Must be comfortable and efficient in a fast-paced, dynamic and growing environment.

• Must be able to work under minimal and at times no supervision, prioritize and determine personal work plan, schedule tasks and activities

Preferences:

• A PhD in a scientific field or a PharmD, DVM or MD degree and 4 years of relevant experience

• Prior experience in cellular therapy, synthetic biology, oncology research

• Work in a scientific field or equivalent experience in association with Research, Translational Sciences/Medicine, R&D project teams and/or in cross-functional project management activities

• Certified Associate in Project Management (CAPM) or Project Management Professional (PMP) certificate

• Scientific writing skills

• Line management or supervisory experience is highly desirable