Scientist I/II - Translational Sciences
In this cross functional position the individual will provide support for the nonclinical and clinical development programs with an emphasis on nonclinical toxicology and ADME. In addition the individual will support Clinical Pharmacology-related activities. In this cross functional role the individual will support and/or coordinating all nonclinical activities within Heron. Additionally, support cross-functional activities within the department including pharmacology, and bioanalytical and roles. Coordination with all Pharmacokinetic CROs for outlining analysis plan, modeling and study reports for all programs.
ESSENTIAL DUTIES & RESPONSIBILITIES:
• Assists or leads in the planning, designing, analyzing, interpreting and reporting of data from nonclinical pharmacology, PK and toxicology studies.
• Leads/coordinates activities associated with the PK and PD analysis and interpretation for Phase I/II/III clinical trials with external CRO and internal teams.
• Lead/ assist in the drafting all necessary documentation and report study results for IND/NDA submissions regarding toxicology, PK and Clinical Pharmacology.
• Coordinate activities and provide support across the Translational Sciences group (Toxicology, PK, bioanalytical sciences), and with other groups such as pharmaceutical sciences and the rest of the organization (clinical operations).
• Receive study updates, data and documents, track and maintain study specific milestones. • Ensure proper following of FDA guidelines and internal SOPs for all studies.
• Creation of various data tables, figures, (e.g., CTD) and documents for regulatory submissions (e.g. IND, IB) and perform QC review of regulatory documents.
• Other duties may be assigned as necessary.
• PhD plus 2 yrs. min experience, MS plus 4 yrs, or BS plus 6 years in pharmaceutical research environment.
• Experience using WinNonlin and programs in PK/PD data analysis and modelling/simulations and data interpretation.
• Experience working with GLP regulations is a requirement.
• Experience designing, monitoring, and reporting of nonclinical studies to support both drug discovery and drug development activities.
• Strong written and verbal communication skills are a must.
• Experience working with animals in a scientific setting.
• Team-oriented with excellent communication and interpersonal skills.
• Flexibility to work in a fast-paced environment. Ability to manage multiple and diverse issues.
• Ability to “roll up your sleeves” and individually contribute results in a team-based environment.
• Experience authoring of documents, reports and presentations.
• Basic knowledge of FDA and ICH nonclinical guidelines and the ability to interpret and apply applicable regulations.
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position. EOE