Director, Clinical Pharmacology

Posted 22 Days Ago
Be an Early Applicant
Hiring Remotely in Cary, NC, USA
In-Office or Remote
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Lead clinical pharmacology strategy and execution across PK/PD, modeling, and simulation. Design, analyze, and interpret clinical pharmacology studies (SAD/MAD, ADME, DDI, TQT, BE/BA), develop PK/PD and statistical analysis plans, review regulatory documents (INDs, NDAs, IBs), and advise clients on dosing, sampling, and development strategies.
Summary Generated by Built In

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-TCW

Skills Required

  • PharmD or Ph.D. in a relevant area
  • 8+ years of relevant work experience
  • Experience independently leading clinical pharmacology activities and cross-functional client engagement
  • Expertise in noncompartmental analysis, population PK, PBPK, and QSP modeling
  • Proven experience designing, analyzing, and interpreting clinical pharmacology studies (SAD, MAD, ADME, DDI, TQT, BE/BA)
  • Ability to develop and review statistical and PK analysis plans, PK/PD reports, and clinical/regulatory documents (IND, NDA, IB, FDA briefing packages)
  • Strong written and verbal communication skills with good command of English
  • Client-focused mindset
  • Ability to work effectively in a fast-paced environment
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The Company
HQ: Cary, NC
1,436 Employees

What We Do

Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.

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