Software Guidance & Assistance, Inc., (SGA), is searching for a Clinical Services Manager/Clinical Pharmacologist for a Contract assignment with one of our premier Healthcare clients in Boston, MA. (100% Remote EST Hours)
- Responsibilities :Provide clinical pharmacology expertise and strategic leadership in the review, analysis, and interpretation of study results for clinical pharmacology studies (e.g, DDI, BA/BE, organ impairment studies, etc.) and clinical pharmacology elements in efficacy/safety trials.
- Conduct literature reviews as needed for study rationale and interpretation of study data
- Provide technical oversight and work in conjunction with medical writing to support regulatory submission document authoring
- Review PK TFLs and pharmacometrics reports and provide interpretation
- Required Skills: PhD in Pharmaceutical Sciences, Pharmacokinetics, Clinical Pharmacology or related fields
- 8+ years of relevant experience
- Demonstrated success in executing clinical pharmacology programs for small molecule therapeutics
- Strong knowledge of PK/PD principles, ADME concepts and FDA Office of Clinical Pharmacology regulatory guidances
- Prior NDA submission experience (CTD Sections 2.7.2, 2.7.2, 2.5)
- Strong understanding of noncompartmental and model-based PK and PK/PD analyses
- Scientific writing skills are essential
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com/ .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy.
