Up To 6 months
Raleigh-Durham, North Carolina / Remote
Our client is a specialist life sciences consulting company that provides product development and regulatory consulting to Pharmaceutical, Biotechnology, Generics and Medical Device companies. The company has worked with the world’s leading companies, guiding them through their key product development and regulatory decision milestones, from proof of concept to commercialization and post marketing.
What You'll Do
- Work independently and with the team to develop a cross-functional development plan from current stage through product launch.
- Manage the execution of deliverables, both short and long-term, via clearly defined milestones, and timelines. Minimize timeline deviations by clearly identifying program risks and communication of strategies.
- Build and sustain robust business processes to support cross-functional clinical trial execution.
- Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).
- Facilitate regular project team meetings, issue written minutes, and follow up on action items.
- Maintain overall project dashboard, schedule, budget, project plans, operational plans, and routine reports to sponsors and stakeholders.
- Represent client to external partners groups as required.
- Responsible for working with clients to develop detailed project plans and managing the execution of their projects.
- Use Project Management methodology tools and systems as agreed with the client, to manage and report on the development of their project – maintaining up to date and accurate project plans and budgets and working as a key source of contact and information on processes.
- Ensure that key development milestones are achieved, key deliverables are produced, and that the assigned program proceeds based upon the timeline and budget.
- Assists customer in building cross-functional project teams and lead those teams, as appropriate.
- Develops and plans a project charter, schedule, resourcing plan, budget and risk list with proposed mitigation plans.
- Manages the scope, schedule, budget, resources, team and sponsor meetings, progress and milestones of their assigned project.
- Builds positive working relationships with clients, consultants, internal and external teams and leadership. Assists in maintaining customer relationship and ensuring repeat business.
- Serves as the point person for customer contact on all project-related issues and communications.
- Initiates resolution and escalation process when significant issues arise, especially those that risk deviations in timelines, quality, or resourcing/cost as stipulated in clients vendor contracts.
- Identify risks or changes to the quotes/contracts with client vendors and discuss those with client team members to ensure that changes are appropriately documented and agreed upon with the client prior to implementation.
- Supports business development activities in bringing relevant subject matter expertise and identifying client challenges and opportunities.
- Bachelor’s degree in a relevant scientific discipline (MS/MBA or doctoral degrees preferred).
- Professional knowledge and experience in life sciences R&D processes with understanding of operations and subject matter.
- Minimum of 5-7 years of experience working in program management and operations for pharmaceutical and/or biotechnology companies, and delivering client advisory information.
- Familiarity with biotechnology product development processes, with significant knowledge in one or more functions (e.g. CMC, non-clinical, clinical, regulatory, etc.).
- Strong understanding of ICH, GCP and CFR guidelines.
- Demonstrated leadership capability and experience serving as a daily resource for leading projects and engaging with leadership teams.
- Experience in agile change management with ability to create a change strategy and plan where needed and define change workstreams and resources.
- Excellent communication, negotiation, and interpersonal skills.
- Possesses strong business acumen and is organized, results-oriented, and a strategic thinker.
- Proficient in independent thinking and reasoning ability.
- Knowledge of MS Project or other relevant enterprise project management software systems used for timeline/budget/resource planning and reporting.
- Knowledge of project management principles (PMP Certification preferred).
- Familiarity with LSS principles; Operational Excellence (Black Belt/Green Belt preferred).
- Ability to communicate complex issues in a concise, coherent, and professional manner.
- Ability to negotiate difficult issues in a well thought out and professional manner.
- Ability to work effectively under pressure to meet deadlines.
- Ability to interpret a variety of instructions provided in written, oral, diagram, or schedule form in a short amount of time.
- Willingness to travel approximately 10% of the time depending on project and client needs.
- Advanced science degree, preferably in pharmacy or medicine
- Experience in leading / supporting business development
- Cell and Gene Therapy industry experience