Sr. Scientist, Pharmacometrics

BioCryst

Posted on: June 20, 2022

Closing: July 20, 2022

Salary: Undisclosed

Position Type: Full Time

Job Description

At BioCryst, we are passionate about advancing novel therapeutics for patients with rare and serious diseases.
Our structure-guided drug design process leads us to the discovery and development of novel small-molecule drugs. We integrate traditional biology and medicinal chemistry along with a wide array of advanced technologies to understand the three-dimensional structures of active sites of target enzymes. Our scientists then design molecular structures to create bespoke drugs for patients. We focus on therapeutic areas with either no available treatments or large unmet patient needs. BioCryst’s US headquarters are located in Durham, North Carolina, our European headquarters in Dublin, Ireland and our Discovery Center of Excellence in Birmingham, Alabama. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit the Company’s website at www.biocryst.com.

JOB SUMMARY:

The Senior Scientist, Pharmacometrics (SSP) provides support for population pharmacokinetic (PK), pharmacokinetic-pharmacodynamic (PK-PD), exposure-response (E-R) analyses and disease state modeling. The SSP will be responsible for appropriately selecting PK, PD and biomarker sampling strategy in Phase 2 and 3 studies (including protocol preparation, analyses and reporting). For early development projects, the SSP may model preclinical data to support Phase 1 first-in-human studies and collaborate with Clinical Pharmacologists to support in silico modelling. With appropriate mentorship, the SSP may also act as a Pharmacometric representative for new development programs initiated by BioCryst. #LI-Remote

 

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Responsible for the pharmacometric strategy to incorporate in Phase 2 and 3 studies: design, implementation, analysis, interpretation, reporting and regulatory submission
• Performs or oversees (CROs) population PK and PKPD analyses of Phase 2 and 3 studies, provide support for clinical study protocols and reports, and site initiation visits/investigator’s meetings
• Collaborates with clinical pharmacologists to select the best appropriate approach for PK and PKPD assessments in Phase 2 and 3 clinical studies
• Integrates clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical, statistics, nonclinical ADME, toxicology to support and impact development decisions
• Contributor to regulatory documents including investigator’s brochures, briefing documents, IND applications/annual reports, responses to regulatory queries, and pharmacometric sections in NDAs/MAAs
• Communicates out key population PK, PKPD and E-R data at scientific meetings and authors/ reviews manuscripts for submission to peer-reviewed journals
• Participates in development of clinical pharmacology group activities including SOPs, department procedures and software acquisition/testing

 

EXPERIENCE & QUALIFICATIONS:

• PharmD or PhD in Pharmacokinetics, Pharmacometrics, Engineering, or other suitable post-graduate qualification
• 3+ years of industry or equivalent experience in population PK/PKPD modeling is preferred
• Ability to use specialized population PK software like NONMEM at an advanced level, experience in in-silico modelling will be a plus
• Experience with population PK/PKPD components of NDA or MAA submission will be preferred
• Scientific rigor in experimental design, study conduct, analysis, interpretation, and communication of results
• Able to manage population PK vendors as needed
• Excellent written and verbal communication skills
• Proficient with standard software packages (e.g., Excel, Word, Power Point)
• Accomplish work in order of priority and adjust to new situations to meet team timelines
• Ability to negotiate conflict and maintain constructive working relationships with people at all levels of the organization
• Strong interpersonal skills and ability to work effectively in team environment
• Capable of maintaining professional skills and learning new ones when necessary
• Able to lead production and authoring of scientific documents with full attention to accuracy and consistency

 

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veteran’s status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state, and local law.

BioCryst

Posted on: June 20, 2022

Closing: July 20, 2022

Salary($): Undisclosed

Position Type: Full Time

Career Focus: Scientist

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