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Director, Clinical Pharmacology

8+ years
Not Disclosed
10 Oct. 22, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Director, Clinical Pharmacology

Job Details

  • Job Location: Remote - Boston, MA
  • Remote Type: Fully Remote
  • Position Type: Full Time
  • Education Level: PhD
  • Travel Percentage: Minimum of 2x/year to Boston area
  • Job Category: Biotech

Reports to: Senior Vice President, Head of Clinical Development

Position Summary:

The Director, Clinical Pharmacology is responsible for defining and executing the clinical pharmacology components of drug development programs, from early translational stages through late-stage clinical development. This role involves collaborating with cross-functional team members to design, analyze, and interpret clinical pharmacology studies, applying quantitative approaches to inform dose selection and support product development decisions.

Primary Responsibilities:

  • Plan, design, and interpret results of clinical pharmacology studies (e.g., DDI, BA/BE studies) and related elements in efficacy/safety trials.
  • Provide clinical pharmacology expertise to project teams and proactively identify opportunities for model-based integration into development plans.
  • Contribute to documents including development plans, protocols, analysis plans, and study reports for regulatory authorities.
  • Perform noncompartmental analyses independently and oversee external collaborators.
  • Stay informed on advancements in quantitative pharmacology.
  • Assist in authoring regulatory documents.

Education and Professional Preferred Experience:

  • PhD or PharmD in Pharmaceutical Sciences or a related field; experience in pharmacometrics preferred.
  • 8+ years of relevant experience, with a minimum of 5 years in drug development/pharmaceuticals.
  • Demonstrated success in executing clinical pharmacology programs and applying quantitative methods in small molecule therapeutics.
  • Strong knowledge of PK/PD principles, ADME concepts, and regulatory requirements in clinical pharmacology.
  • Experience using Model Informed Drug Development.
  • Knowledge of health authority perspectives on Clinical Pharmacology.
  • Experience in developing small molecules and/or antisense oligonucleotides.
  • Proficient in Phoenix WinNonlin or similar tools.

Compensation & Benefits:

  • 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans.
  • Quarterly bonus program.
  • 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth).
  • Wellness benefit of $200/month for flexible options (e.g., travel, fitness, student loan repayment).
  • Unlimited PTO, (2) weeklong shutdowns each year, and generous extended family leave.
  • Eligibility for equity awards and Employee Stock Purchase Plan (15% discount).
  • Base salary range: $220,000 to $240,000, commensurate with job level, education, and experience.

Company Overview:

Praxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders characterized by neuronal imbalance. We aim to reshape human conditions by developing impactful medicines for patients and families affected by complex brain disorders. Our core values—Trust, Ownership, Curiosity, and Results—guide our business practices.

Diversity, Equity & Inclusion:

Praxis is committed to promoting diversity, equity, and inclusion, encouraging individuals to bring their authentic selves to work. We are an equal opportunity employer, providing opportunities to all qualified applicants without regard to race, creed, gender identity, age, national origin, sexual orientation, disability, or any other protected characteristic.

Attention: Job Scam Alert:

Beware of fraudulent job postings claiming to represent Praxis. If you suspect any fraudulent activity, please report it to careers@praxismedicines.com.

Recruitment Agency Notice:

Praxis does not accept unsolicited submissions from recruitment agencies. All unsolicited resumes submitted will be deemed the property of Praxis, which reserves the right to hire candidates without financial obligation to the agency.