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Project Management / Clinical Pharmacology Specialist

We seek a self-motivated, detail-oriented individual for a combined project management & scientific position. This position will seek to create efficiencies within our organization by ensuring timely and thorough completion of project milestones and facilitating overall communication between team members and clients across multiple projects. Also, the individual will contribute to pharmacokinetic/pharmacodynamic clinical, regulatory, and nonclinical projects as needed.  This is a “self-starter” position with the direction and responsibilities ultimately determined by the drive and career goals of the individual.  This position will be of interest for an individual looking to make an entry into pharmaceutical drug development.

The ability to work with large and dynamic project teams in a rapid-paced environment is key to the success of this position.

Responsibilities

  • Manage project deliverables and milestones, including personnel and resource allocation
  • Track project scope, budgets, and timelines
  • Maintain high level timelines with input from functional departments and clients
  • Serve as a member of project teams to assure that functional deliverables are supplied on time, on budget and according to quality standards
  • Supervise subcontractor and outside professional service activities
  • Coordinate project team meetings (scheduling, agenda preparation, material preparation, minutes distribution, etc.)
  • Seek timely progress for action items and resolution to issues identified on projects
  • Follow-up on critical action items and alert project team of potential roadblocks or delays
  • Act as a point of contact for clients and Nuventra team members across multiple projects
  • Assist with developing proposals for clients and assist with management of budgets and contracts
  • Maintain current knowledge of PK and PK/PD science, regulatory guidance documents, FDA rulings, internal SOPs, and internal working practices
  • Work with pharmacokineticists and clinical pharmacology consultants at a project assistant level to finalize PK/PD deliverables for clients
  • Assist in development of statistical and PK analysis plans and support production of standalone PK/PD reports that can be appended to clinical study reports
  • Assist with the preparation, review, QC, and formatting of clinical protocols, clinical study reports, clinical pharmacology strategic plans, INDs, clinical pharmacology and safety sections of NDAs, Investigator Brochures, FDA briefing packets, and other clinical and regulatory documents
  • Contribute to clinical pharmacology studies from an operational perspective to assist clients in setting up and executing early phase human trials.  This may include onsite monitoring of clinical trials
  • Function as a flexible resource for clients and internal staff

Qualifications

  • As this position will be client-facing and will interact with cross-functional teams within Nuventra, excellent interpersonal and communication skills are a requirement
  • An advanced scientific degree (MS, PhD, MD) preferred
  • Prior experience in pharmaceutical, healthcare, or scientific-related industry is a plus
  • Proven project leadership and project management skills are important
  • Ability to learn and understand Nuventra’s business of pharmacokinetics and clinical pharmacology services combined with the ability to communicate technical and scientific details of Nuventra’s business to clients as related to clinical pharmacology studies (renal, hepatic, thorough QT, ADME, drug interaction, bioequivalence/bioavailability, single ascending dose, multiple ascending dose, etc.), PKPD analysis, and population PK modeling and simulation
  • Excellent Microsoft Office skills are required
  • Prior experience using project management software (eg Microsoft Project) is a plus
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