Head of Clinical Pharmacology

Location:  This position may be performed remotely with travel to the Boston area as needed.

The Opportunity

The Head of Clinical Pharmacology will help drive the development of groundbreaking therapies by shaping clinical pharmacology strategies and leading a high-performing team of clinical pharmacologists and pharmacometrics. The candidate is responsible for developing the clinical pharmacology strategy and overseeing all aspects of clinical pharmacology studies, including designing clinical trial protocols, analyzing pharmacokinetic (PK) and pharmacodynamic (PD) data, interpreting results, and guiding drug development strategies based on clinical pharmacology insight. The ideal candidate will have extensive experience in the application of pharmacokinetic (PK) and pharmacodynamic (PD) principles to drug development, with a background in pharmacokinetic modeling.

Primary Responsibilities

• Develop and execute comprehensive clinical pharmacology strategies for drug development programs across Ph1 to Ph3. 
• Collaborate with cross-functional teams (clinical development, regulatory affairs, DMPK, CMC) to integrate clinical pharmacology and PK/PD data into overall drug development plans. 
• Provide clinical pharmacology expertise and input into project teams and proactively identifies opportunities to integrate model-based approaches into development plans
• Design and oversee clinical pharmacology studies, and author clinical study protocols, statistical analysis plans, and clinical study reports
• Develop and apply pharmacokinetic/pharmacodynamic (PK/PD) models and simulation techniques to support drug development, dose optimization, and regulatory submissions
• Interpret and communicate PK/PD modeling and simulation findings to non-specialist stakeholders, including project teams and regulatory agencies
• Lead a team of clinical pharmacologists and pharmacometrics, and provide mentorship and career development opportunities for team members
• Stay updated on the latest advancements in clinical pharmacology, including novel methodologies and technologies. 
• Contribute to the preparation of regulatory submissions, scientific publications, and presentations at scientific conferences

Qualifications and Key Success Factors

• PhD or PharmD in Pharmaceutical Sciences or related field required, with experience in pharmacometrics preferred
• 10+ years of relevant experience, with 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
• proven track record of applying PK/PD modeling and simulation in the pharmaceutical industry and experience in the use of Model Informed Drug Development to advance development programs
• Experience with software tools for pharmacokinetic modeling and simulation (e.g., NONMEM, Phoenix WinNonlin, MATLAB, R)
• Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies
• Effective communication and collaboration skills, with the ability to work as part of a multidisciplinary team and interact with stakeholders
• The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position. Work is performed in a remote, work from home environment. The employee is regularly required to sit; use hands and fingers; reach with hands and arms; and talk and hear. The employee is occasionally required to stand, walk, and climb or balance. Movement through sites and labs may occasionally be required as employee may need to visit these environments. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Visual acuity is required to read and produce accurate materials. Use of keyboards and cellular devices.

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 annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.