10 days old

Team Leader, Program Management

PDS Biotechnology
Metro Park, New Jersey 08830

PDS BIOTECHNOLOGY

 

Job Title:       

Team Leader, Program Management

Department:

Operational Excellence

Reports to:

VP, Clinical Operations

Date Created or Revised:

August 7th, 2019

Location:       

Metro Park, NJ

 

PDS Biotechnology, a NASDAQ-listed company, is a clinical stage biotechnology company focused on the utilization of the company’s proprietary Versamune® nanoparticle platform in the development of novel immunotherapies and vaccines for infectious diseases and cancers. Our lead clinical program is entering Phase II human testing in multiple indications in 2020.

  

The Team Leader / Project Leader, Project management position will be primarily responsible for leading all projects for the development of PDS products across the company. This position will collaborate with a group (internal and external) of highly skilled and committed scientists and professionals to execute internal programs to meet timelines while staying on budget.

The Team Leader / Project Leader will report directly to PDS Biotechnology’s Vice President of Clinical Operations, and will work closely with all Department heads across Clinical, Preclinical, Manufacturing and Finance. The Project Leader / Team Leader is accountable to successfully execute the project strategy,drug development, and lifecycle plan. The Project Leader / Team Leader will promote a strong “team” performance culture marked by a commitment to excellence, flawless and timely execution, innovation and results orientation. This requires the ability to lead, interact with all levels of management, influence teams, and make decisions that achieve corporate goals and objectives. This demands excellent communication skills, analytical and problem-solving abilities, as well as process-oriented project management capabilities to build and develop a project management structure and models that facilitate driving results, speed in decision making, accountability to deliverables and timelines.  This will also require a leader that will identify issues, timely raise them with solutions, and ensure that project management is the engine for PDS that moves us forward to success.

This is an exciting opportunity to join a small, nimble and rising organization.  The right candidate will have the opportunity to learn, grow, and make a difference to the lives of the patients we serve. 

This role will heavily influence and impact the direction of the organization. Successful performance in this role will contribute to meeting PDS’s corporate objectives and overall success of our developing product pipeline and the launch of new and innovative products. 

 

 

 

Primary responsibilities include, but are not limited to, the following:

Clinical Project Management

  • Support clinical leadership and team with analytical needs including:
  • Enrollment modeling
  • Project tracking of milestones, tasks, issues and risks
  • Leadership and Support in identifying and raising issues and risks and ensuring timely resolution
  • Clinical analytics as needed, including ad hoc analysis, support of Pre-Clinical studies, and other needs as indicated by the CMO and/or VP of Clinical Operations
  • Attending cross functional meetings with Regulatory, Clinical, Medical and Preclinical to assemble comprehensive holistic timelines of the product development needs from bench to market.
  • Maintains high level timelines, and assures consistent and detailed timelines with input from the functional departments, and assures that the functional timelines are aligned with the project timelines.

Preclinical Project Management

  • Provide project management support for advancement of PDS’ early-stage product pipeline to IND, including internal CMC development and external CMC outsourcing, preclinical animal studies, regulatory preparation and filing(s), and the related project timelines, financial forecasting, and budget-to-actual activities.
  • Maintain a “playbook” which includes all key project tools and documents
  • Responsible for the conduct and deliverables of Project Team Meetings

Budget Management & Vendor selection

  • Build and manage product budgets for Clinical, Regulatory, Pre-Clinical and Manufacturing
  • Facilitates financial risk and mitigations
  • Participates and supports vendor selection process including RFP process and comparative comparison.

Coordinate and Plan

  • Drive results with an entrepreneurial mindset to become an integral part of a dynamic, fast-moving team working to get new medicines to market
  • Able to deal with pressures and timelines inherent in a small company and develop appropriate and right sized project plans, schedules and timelines
  • Ability to review and plan for the growth of the company by supporting resource management.

Integrator and Influencer

  • Decisive and able to take action after considering alternatives, data and risks
  • Demonstrated strong interpersonal skills to ensure positive team relationships combined with the ability to work independently to drive programs through to completion
  • Mature and self-assured person but must be a team player who will work well with all other functional areas and develop a cohesive relationship among the team
  • Hands-on team leader with involvement in all aspects of the research and development organization’s day-to-day operations
  • Excellent written and verbal communication skills and ability to make effective presentations to CEO, CFO and possible Board of Directors.

 

 

 

 

 


Requirements

Primary skills and knowledge required include, but are not limited to the following:

  • Demonstrated expertise in project management with knowledge of clinical trial management, systems and data
  • Excellent organizational skills and use of planning tools
  • Highly proficient in Microsoft Suite products; Word, PowerPoint, Excel, Outlook
  • Effectively utilizes information technology systems and provisional project management tools
  • Competent in planning and managing meetings within a multicultural environment
  • Team oriented, able to build constructive relationships with multiple, diverse team members
  • Attention to detail, accuracy and a tenacity for follow-up
  • Leadership capability: able to drive strategic program plans across the development timeline while also identifying key milestones, interdependencies to ensure deliverables are met and/or exceeded
  • Ability to hold self and others accountable for commitments in a productive, assertive, and positive manner
  • Ability to influence outcomes without direct authority
  • Strong communication skills, both written and verbal
  • Ability to communicate well, both one-on-one and within small groups
  • Able to manage project with limited instructions from project leader on a daily basis
  • Self-sufficient and self-starter able to identify process and innovation opportunities within the company.
  • Knowledgeable across all stages of drug development (early, late and lifecycle)

 

 

 

  

In order to work effectively in PDS’s dynamic, matrix environment, every employee must have a strong mix of key attributes & competencies including, but not limited to, the following:

 Demonstrate the Behaviors that Define PDS Fosters Teamwork – Fosters an environment in which people trust and value each other and recognize the importance of each role in the organization; recognizes the impact of cultural differences on teams; encourages cooperation, coordination, and information sharing. Should start from a place of good intentions and give the benefit of the doubt with regard and respect for others.

 

  • Results driven - Has an entrepreneurial mindset, sense of urgency and commitment to become an integral and hands-on part of a dynamic, fast-moving team working to save patients’ lives.
  • Drives execution – Gets things done by setting clear expectations, monitors progress, and consistently follows up.  Maintains attention to detail and accuracy and the highest degree of integrity.
  • Promotes Open Communication – Creates an environment where communication is expected, supported, clear, candid, transparent and relevant; listens actively and encourages open expression of ideas and opinions, including creative suggestions that will create the most efficient and effective methods for achieving PDS’s business goals.
  • Demonstrates Adaptability – Demonstrates an ability to adapt appropriately to changing conditions, including business situations, people and changing priorities; an ability to work constructively under pressure; an ability to respond resourcefully to change and ambiguity and learn from one’s mistakes.
  • Manage Risk – Demonstrates ability to take and manage appropriate risks and use them to the organization’s advantage. Commits to professional growth and continual improvement in order to fuel PDS’s growth.

 

 

 

 

Level of education required:   

  • B.S. / B.A. 
  • Ph.D. and/or M.B.A. desirable

 

Number of Years of Experience in the Function and in the Industry:

  • Minimum of 5 years pharmaceutical drug development background and exposure to one or more of the following areas highly preferred;: Early development i.e. preclinical to Phase 2, inflammation & immunology disease areas, hematology/oncology 
  • Experience in early phase of drug development preferred
  • Three years project management expreince or equivalent
  • PMP certification desirable
  • Certification in GCP or GMP preferred.
  • Sr. Manager to AD Level experience

 

 

Salary Details

Compensation is based on relevant experience, skills and background commensurate with the position requirements.

Categories

Posted: 2019-08-14 Expires: 2019-09-28

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Team Leader, Program Management

PDS Biotechnology
Metro Park, New Jersey 08830

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