Remote Director, Clinical Pharmacology

Allucent; Abilene (TX); Hybride; USD 180 000 - 240 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits package per loc

Flexible working hours

Remote/hybrid options depending on loc

Leadership and mentoring opportunities

Internal growth opportunities

Employee referral program

Résumé du poste

Allucent seeks a Director, Clinical Pharmacology to independently lead clinical pharmacology activities within the Clinical Pharmacology, Modeling, and Simulation unit. Office-based or remote, you will provide strategic pharmacology advice to clients and oversee design, analysis, and interpretation of PK/PD studies.

You will review protocols, study reports, INDs, NDAs, and briefing packages, mentoring teams, and ensuring regulatory readiness.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Written communication

Verbal communication

Client focus

Fast-paced environment

Formation

PharmD or Ph.D.

Description du poste

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

• 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.

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 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."