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Director, Clinical Pharmacology

Posted about 2 months ago

RemoteCary, North Carolina, United StatesEX

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Director, Clinical Pharmacology to join our A-team (office-based*/remote). As a Director, Clinical Pharmacology at Allucent, you are responsible for independently leading Clinical Pharmacology activities within the Clinical Pharmacology, Modeling, and Simulation unit of Allucent.

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

Benefits of working at Allucent include:

  • 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
  • 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

Disclaimers:

*Our office-based work policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

#LI-Remote #LI-Hybrid #LI-TCW

Job details
Workplace
Remote
Location
Cary, North Carolina, United States
Experience
EX

Allucent is a global, full-service CRO specializing in biotech & small-to-mid-size pharma. Get expert clinical research solutions & accelerate your development.

Employees
1363
Industry
Pharmaceutical Manufacturing
Headquarters
Cary, North Carolina
Company location
2000 Centregreen Way, Suite 300, Cary, North Carolina 27513, US
Specialties
Drug Development, Regulatory Affairs and Submissions, Clinical Strategy, Cell & Gene Therapy, Rare Diseases & Orphan Indications, Oncology & Hematology, Study startup & Feasibility, Regulatory Strategy, Small and midsized biotech companies, Biostatistics, Pharmacokinetics (PK) / Pharmacodynamics (PD), Clinical Pharmacology, Medical/Scientific Writing, Protocol and study design, Medical monitoring, Patient recruitment, Pharmacovigilance, Data management, NDA/BLA/MAA, and Product development

Key team members

Michiel Hartman

Michiel Hartman

Amy Mills

Amy Mills

Marcus Delatte, PhD

Marcus Delatte, PhD

Sukh Lal Singh ( S L S )

Sukh Lal Singh ( S L S )

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