Senior Pharmacokinetic ScientistReports to: Director, Clinical PharmacologyLocation:  This position may be performed remotely with travel to the Boston area as needed.

Position Summary

This scientist is part of our Clinical Pharmacology department, accountable for providing senior level quantitative PK support across Praxis Drug Development teams. This includes, but is not limited to, hands on and/or validation support for pharmacokinetic (PK) non-compartmental (NCA) data analyses and population PK/pharmacodynamic (PD) analyses. This scientist will support clinical trial reporting, compound development plans, and regulatory submissions, and will provide strategic direction and vision to support PK/ PD data analysis and modeling in collaboration with consultants.

Primary Responsibilities

• Conduct or perform validation of PK data analysis using NCA. Perform review of source data for applicability of subject and data inclusions in the analyses.
• Provide appropriate and accurate interpretation of study results related to PK and/or PD endpoints.
• Provide guidance and serve as a liaison for the conduct of modeling and simulation and/or disease modeling with external vendors.
• Generate predictive simulations with nonclinical and/or clinical data.
• Provide input into trial protocol development; write or review clinical trial Statistical Analysis Plans including PK or PK/PD analysis components or write or review separate PK/PD Analysis Plans.
• Author and/or review PK/PD related components of internal and external publications/presentations.
• Author and/or review clinical pharmacology sections of relevant regulatory documents, such as clinical study protocols, clinical study reports, investigator's brochures, briefing documents, and IND/NDA/ANDA/BLA submissions.
• Work closely with regulatory affairs personnel to provide PK/PD data in support of regulatory communications and presentations as needed.
• Provide mentorship, including PK software training, as required.
• Play an active role on cross-functional project teams as a clinical pharmacology representative.

Qualifications and Key Success Factors

• Advanced degree, PhD preferred, or M.Sc. in Clinical Pharmacology (including Pharmacokinetics, Pharmacodynamics), Biopharmaceutics or related fields.
• Minimum of 5 years experience as a PK scientist in pharmaceutical clinical trials.
• Comprehensive knowledge of PK/PD principles, ADME concepts and regulatory requirements related to clinical pharmacology, M&S, and drug development.
• Demonstrated success in executing clinical pharmacology programs and the application of quantitative drug development in small molecule therapeutics.
• Excellent pharmacometrics and computational skills with an integrated understanding of clinical development as well as hands-on experience working at the interface of drug discovery and development.
• Hands-on experience with standard PK and M&S software (e.g., Phoenix WinNonlin/NLME, NONMEM, R, S-Plus, SimCYP) to drive M&S activities (e.g., population PK and PK/PD, exposure-response, PBPK)
• Skilled in scientific writing and data interpretation with excellent communication skills to translate and summarize PK/PD and M&S data and outcomes of analyses as relevant for discovery and development projects
• Ability to prioritize and manage multiple projects with competing and aggressive timelines.
• Demonstrated ability for logical thinking, vision, and creativity necessary to function effectively with a large degree of independence.
• Must have openness to new ways of working and innovative ideas.

Compensation & Benefits

At Praxis, we’re proud to offer an exceptional benefits package that includes:

• 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
• Bonus program structured to pay on a quarterly basis
• 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
• Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
• Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit
• Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)

To round out this world-class total rewards package, we provide base salary compensation in the range of $145,000 to $154,000 annualized. Final salary range may be modified commensurate with job level, education, and experience.

Company Overview 

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. 

Diversity, Equity & Inclusion

Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE™ to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

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