Director, Clinical Pharmacology
Allucent · Cary, NC · 3 wk ago
RemoteRemoteConsultingFull-time
About the role
As an expert in clinical pharmacology, you will:
- Take independent leadership in providing strategic clinical pharmacology advice to clients within a cross-functional team, covering overall drug development activities.
- Autonomously lead the design, analysis, and interpretation of clinical pharmacology studies (including renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and offer recommendations to enhance pharmacokinetic sampling and dosing strategies.
- Thoroughly assess the technical and scientific components of PK and PK/PD projects and programs for clients, with knowledge of noncompartmental analysis as well as population PK, PBPK, and QSP modeling.
- Oversee the development of statistical and PK analysis plans, standalone PK/PD reports, and PK/PD sections of clinical study reports, and take the lead in reviewing clinical protocols, clinical study reports, clinical pharmacology strategic plans, INDs, clinical pharmacology and safety sections of NDAs, Investigator Brochures, FDA briefing packages, and other clinical and regulatory documents.
Requirements
To be successful you will possess:
- PharmD or Ph.D. in a relevant area
- 8+ years of relevant work experience
- Strong written and verbal communication skills including good command of English language
- Client focused
- Ability to work in a fast-paced environment
Benefits
- Comprehensive benefits package per location
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for remote/hybrid* working depending on location
- Leverage Leadership and mentoring opportunities
- Participation in our Buddy Program as a new or existing employee
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
Pay
Competitive salaries per location
Schedule
Flexible Working hours (within reason)