Please note that due to the COVID-19 pandemic, this position is currently remote however once we return to the office this position will be based in one of our locations (Durham, NC; Denver, CO; Philadelphia, PA). 

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

Apply for this Job

* Required

  
  
When autocomplete results are available use up and down arrows to review
+ Add Another Education


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at Nuventra Pharma Sciences are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.