Job Description
Director, Clinical Pharmacology Reports to: Senior Vice President, Head of Clinical Development Position Summary The Director, Clinical Pharmacology is responsible for defining and executing clinical pharmacology components of drug developing programs for compounds from the early, translational stage through to late-stage clinical development. Working collaboratively with cross-functional team members, the clinical pharmacologist designs, analyzes and interprets clinical pharmacology studies, and applies quantitative approaches to implement translational PK/PD strategies, inform dose and dosing regimen selection and support product development decisions. Primary Responsibilities This role encompasses a wide range of responsibilities associated with clinical pharmacology, pharmacokinetics (PK), and pharmacodynamics (PD), among other duties. Plan, design, and interpret results of clinical pharmacology studies (e.g., DDI, BA/BE studies, etc.) and clinical pharmacology elements in efficacy/safety trials. Provide clinical pharmacology expertise and input into project teams and proactively identify opportunities to integrate model-based approaches into development plans. Actively contribute to documents including development plans, protocols, analysis plans, study reports and summaries for regulatory authorities. Perform noncompartmental analyses independently and through oversight of external collaborators. Remain informed of emerging advancements in quantitative pharmacology. Assist in the authoring of regulatory documents. Education and Professional Preferred Experience PhD or PharmD in Pharmaceutical Sciences or related field required, with experience in pharmacometrics preferred. 8+ years of relevant experience, with a minimum of 5 years within drug development / pharmaceuticals industry. Demonstrated success in executing clinical pharmacology programs and the application of quantitative drug development in small molecule therapeutics. Strong knowledge of PK/PD principles, ADME concepts and regulatory clinical pharmacology requirements. Experience in the use of Model Informed Drug Development to advance development programs. Knowledge of Health Authority perspectives on Clinical Pharmacology. Experience working on the development of small molecules and/or antisense oligonucleotides. Proficient in the use of Phoenix WinNonlin or other similar tools. 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 $220,000 to $240,000 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. #J-18808-Ljbffr