Director, Clinical Pharmacology: PK/PD Strategy Lead

BioSpace

Waltham (MA)

On-site

USD 180,000 - 260,000

Full time

9 days ago

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Job summary

AbbVie is seeking a senior leader in Clinical Pharmacology to articulate strategy to senior management, regulatory agencies, and external peers. You will guide drug development activities and translate PK/PD data into actionable plans.

You may lead teams, provide scientific consultations across R&D, Regulatory, and management, and ensure project alignment with strategic objectives while advancing CLINICAL PHARMACOLOGY efforts.

Qualifications

  • PhD with typically 7+ years of experience or PharmD with typically 9+ years of experience in a relevant field, MS or equivalent education with typically 15+ years of experience; BS or equivalent education and typically 17+ years of experience

Responsibilities

  • Leads Clinical Pharmacology/PK/PD activities and multiple major projects.
  • Identifies issues and help with issue resolution; conducts risk assessments.
  • Provides overall timelines to assess portfolio opportunities and negotiates with other functions.
  • Provides scientific and strategic consultation to R&D, Regulatory, and management.
  • Reviews clinical protocols and regulatory documents; leads regulatory submissions.
  • Independently conducts due diligence assessments and represents Clinical Pharmacology on business development teams.
  • Develops process improvements and contributes to departmental goals.
  • Influences PK/PD decisions for the department.

Skills

Interpersonal skills
Therapeutic knowledge
Development phases experience
Drug development knowledge
Leadership in PK/PD
Scientific project leadership
Project management
Cross-functional collaboration

Education

PhD/PharmD with extensive experience

Job description

AbbVie is seeking a senior leader in Clinical Pharmacology to articulate strategy to senior management, regulatory agencies, and external peers. You will guide drug development activities and translate PK/PD data into actionable plans.

You may lead teams, provide scientific consultations across R&D, Regulatory, and management, and ensure project alignment with strategic objectives while advancing CLINICAL PHARMACOLOGY efforts.

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