Scientist/ Sr. Scientist/ Sr. Manager, Pharmacometrics

Job Description

Seeking a scientist with good problem-solving skills and strengths in quantitative analysis. Job duties will be to work in a fast-paced, team-based environment to conduct a variety of complex and independent investigations addressing pharmacokinetic analyses, and other research laboratory experiments to obtain and interpret data for client based and internal based research programs. Successful candidates will be optimistic, solutions-oriented, accountable, and open-minded with a positive, can-do attitude.

Xyzagen (Zi*Za*Gen) is a contract research lab supporting pharmacokinetics, ADME and bioanalytical, pharmacology and nonGLP safety assessments in mice and rats. Xyzagen is also a drug development consultancy providing regulatory advice to clients in the nonclinical and clinical pharmacokinetic disciplines. Xyzagen has provided strategic advice to early NIH funded biotechs, small and mid-size pharma and venture capital firms. At Xyzagen, we accelerate medicines to patients by partnering with life science innovators. In the past 6 years, we have worked with over 100 different innovators and have helped in the approval of multiple new therapeutics by the FDA. Xyzagen also conducts its own research on Kv7 channel openers within the therapeutic areas of Neurology and Pain.

Our strong team of scientists and subject matter experts enable our clients to have:

Cost effective and informed decision-making

Faster study start up for in vivo pharmacokinetic and safety assessment studies in rodents

Wide range of contract research services to regulatory advice regarding pharmacokinetics of a client’s molecule and therapeutic program.

Additionally, we are developing novel cutting-edge chemistry on small molecule ion channel openers of Kv7 ion channels with a focus on neuropathic pain, epilepsy and neuroinflammatory and neuropsychiatric indications.

Job Responsibilities:

Our Scientist/Sr. Scientist/Sr. Manager in Pharmacometrics is responsible for supporting and building the pharmacometrics capabilities in population PK, PK/PD, exposure-response and other modeling endeavors.

Candidates will have the ability to work on a variety of therapeutic indications from Ophthalmology through Respiratory, Pain and Neurology/Psychiatry with large and small molecules and must be knowledgeable in applied Compartmental Modeling, Population PK, PK/PD, and/or exposure-response modelling and simulation to support client needs. The candidate will also be involved in clinical pharmacology and clinical PK study design for phase 1, 2 and 3 clinical trials, noncompartmental pharmacokinetic analysis, and writing of the pharmacokinetic reports and sections of the clinical study reports (CSR) for candidates. The candidate will begin by supporting clinical modeling projects and then expanding the modeling capabilities of the company. The candidate will also be involved in regulatory submissions of client projects. We are looking for the right individual that wants to:

Deepen their experience in in vivo rodent pharmacokinetic studies

Hands on in vivo studies on client projects as a Study Director

Expand their pharmaceutical drug development expertise

Expand their experience informing drug development decisions.

Broaden their drug development expertise by working within companies, molecular modalities, and therapeutic areas.

Hone their pharmacometric techniques with fit-for-purpose modelling approaches leveraging e.g. simple compartmental and population model-based simulations.

Develop their consulting career path by recognizing and seeking opportunities that match their ambition and personal interests.

Hands on pharmacometric modeling on client projects as a billable consultant.

May lead/coordinate company initiatives (e.g. IT, methodology, efficiency, automation, quality).

May act as the primary point of contact for clients and collaborate with the principal or senior consultant to grow business to match their interests.

Qualifications:

MS, PhD, MD, PharmD in Pharmaceutical Sciences, Bioengineering, Pharmacology, Statistics, Applied Mathematics, Medicine, or a related field.

Candidate will have 1 to 4 years of industry experience in in vivo research, modeling and simulation/ 0-2 years consulting experience (may be combined with academic research) working in R&D, pre-clinical and clinical environments.

Solid experience in nonclinical pharmacokinetic and clinical pharmacology study design, pharmacometrics, modeling and simulation and noncompartmental pharmacokinetics, or a related discipline in a project team setting is preferred, whether in academia or industry.

Expertise in PK/PD modelling with strong quantitative skills applied to develop models with nonlinear behavior, mechanistic or semi-mechanistic components relating to mechanism of action and tailored to meet specific drug-development questions.

Experience to Proficiency in PK/PD and statistical software (e.g., Phoenix, NLME, NONMEM, R, Prism).

Experience to Proficiency in modeling (e.g., popPK and PK/PD analyses, model-based meta- analysis, dose-response and exposure-response analyses, dataset creation, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling).

Excellent writing and verbal presentation skills to internal and external audiences. Experience with NIH or Department of Defense grants (nice to have).

Exceptional time management and self-motivation.

This position will range from Scientist to Sr. Manager depending on the individual’s qualifications.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is frequently required to sit or stand for extended periods of time; use fine and gross motor hand skills in ensuring analytical equipment is maintained in operation.

Must be able to speak and hear appropriately to communicate effectively with each associate or vendor.

Specific vision abilities required by this job include close, distance and peripheral vision with the ability to adjust and focus.

The employee on occasion will be required to lift and/or move up to 40 pounds.

Working Conditions:

The noise level in the work environment is usually mild to moderate.

What We Offer:

A competitive salary and meaningful equity compensation

The compensation for this position will range from $75,000 to $115,000 depending on individual’s qualifications.

A bright, collegial, highly motivated team working at the intersection of the most exciting area of science and technology

Exceptional opportunities for learning and growth

Company-paid holidays (closed between Christmas and New Year’s)

Paid time off (2 weeks)

Health benefit stipend

401(k) plan + Safe Harbor Match + Profit Sharing + Defined Benefit retirement plan

Flexible time off for personal business is not tracked

Ability to work from home when possible

Flexible schedule

If relocating 50+ miles, potential for relocation stipend for relevant expenses

Xyzagen is a small company such that we are unable to sponsor visas for any candidate who is not eligible to work in the United States. Additionally, we cannot assist with the transfer of an employment visa from another company.

Powered by JazzHR

ZzSocgCygn

Full-time