Dir. Program Management, R&D cross-functional drug development

Location
Morrisville, NC
Posted
Jun 05, 2022
Ref
1055
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

Company Summary:

Kriya is a next generation gene therapy company focused on expanding the field to new frontiers. We have built a fully integrated, technology enabled platform for rational vector design, analytical characterization, and scalable manufacturing to design and develop gene therapies for diseases with well-understood underlying biology. We believe that rationally engineered gene therapies can transform the treatment of a broad universe of diseases – and we are prepared to lead this revolution in medicine.

Our team is made up of leading scientific experts who are passionate about improving patients’ lives and easing the burden of these life-changing disorders for patients. We are looking for teammates with the ambition, creativity, and energy to help us build a unique organization.

If you are looking to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, Kriya is the company for you.

 

Position Summary:

The Director of Program Management will be responsible for providing cross functional program management support and capacity planning guidance for pharmaceutical development teams.  This individual is responsible for managing activity planning as well as project execution in various areas including nonclinical, manufacturing, clinical, regulatory, and quality.  The Project Manager will play a critical role in planning, coordinating, implementing, executing, and supporting teams for various projects and working with internal and external stakeholders. This position shall adhere to the Company’s quality system including but not limited to the applicable standards, policies and procedures in the areas of responsibility defined in this job description.

Position can be Associate Director or Director level based on experience.

Primary Responsibilities:

  1. Establish, maintain and track integrated project plans, budgets, and resources needed to deliver against company goals.
  2. Effectively partner with internal stakeholders to identify resource and business constraints and avoid scheduling conflicts in the presence of multiple priorities competing for limited resources over the planning horizon.
  3. Conduct scenario planning activities for high level drug development plan strategies & provide strategic decision-making data to senior leadership to drive strategy execution.
  4. Prepare regular project status reports, identify key issues and action plan updates for project meetings.
  5. Identify ways to accelerate project execution where possible while maintaining high quality standards and cost efficiency.
  6. Create and maintain the overall project budget through close collaboration with Finance and external partners.
  7. Monitor performance and recommend scope, schedule, cost or resource adjustments while considering short term demands and long-term implications.
  8. Identify and lead opportunities for business process design and improvements.
  9. Employ excellent interpersonal, communication and negotiation skills with all levels of personnel and management to facilitate information flow between departments and senior management.
  10. Perform duties on site, on time, and within the company operating principles. Facilitate frequent interactions with co-workers and conduct timely problem-solving meetings necessary to address critical and emerging work issues.  Present a positive attitude to create and maintain productive working relationships with fellow employees and vendors.

 

Required Qualifications:

  1. Education
    • Bachelor's Degree in a scientific or technical discipline
    • Master’s degree preferred.
    • PMP Certification preferred.
  2. Experience (level and compensation commensurate with experience)
    • 8+ years project management experience in a pharmaceutical or biotechnology industry.  
    • 8+ years of relevant experience in the pharma/ biotech industry.
    • Exposure to CDMO or CROs strongly preferred.
    • Exposure to Regulatory submissions or major Health Authority requirements and processes preferred including a broad understanding of BLA requirements is important
    • Demonstrated experience with MS Project or Smartsheet, SharePoint, Office Timeline /OnePager or similar software systems/platforms 
    • Project management experience in gene therapy or large molecules preferred. 
    • Familiarity with GxP regulations a plus
  3. Skills
    • This is a dynamic, empowered, collaborative and mission-driven setting. In addition to technical requirements noted above, we seek a smart, insightful, self-directed and competent professional who can gain the respect and cooperation of colleagues and partners in order to achieve shared success. Strong communication skills will be essential.
    • Must have experience with advanced problem-solving and change management methodologies consistent with establishing a culture of continuous improvement.
    • Demonstrated leadership skills and proven ability to work collaboratively between departments.
    • Ability to handle conflict through proactive action and direct and timely communication.
    • Strong interpersonal skills, effective problem solving and decision-making skills.
    • Proven ability to quickly earn the trust of sponsors and key stakeholders and mobilize and motivate teams.
    • Strong analytical, problem solving, critical thinking, and financial planning skills.
    • Hands on experience utilizing project management tools and software solutions.
    • Well-organized professional, with strong verbal and written communication skills.
    • Demonstrated ability to handle multiple competing priorities and work in a fast-paced environment.

 

Kriya is an equal opportunity employer. 

We celebrate diversity and are committed to creating an inclusive environment for all employees.