Associate Director, Clinical Pharmacology/Senior Clinical Pharmacologist

About the role

This position can be hired as either an Associate Director, Clinical Pharmacology or Senior Clinical Pharmacologist. Both roles involve leading Clinical Pharmacology and Pharmacometrics aspects of multiple projects, authoring regulatory documents, and presenting at various meetings.

Responsibilities

• Accountable for Phase 1-4 studies design and clinical pharmacology strategy; acts as the representative for project(s).
• Executes strategy, lead teams and various data analyses and interpretation by providing necessary context (including explaining MoA and disease specifics, available relevant internal and external data, analysis plans, interpretation and discussion of model results in the context of research question).
• Author regulatory documents including protocols, study reports, population PK reports, exposure-response analyses reports, CTDs, label sections, relevant section of investigator brochures, white papers, and other similar documents.
• Leads clinical pharmacology and biopharmaceutics meetings, serve as CLINICAL PHARMACOLOGY representative at Clinical Strategy Team/Asset Development Team and present at various departmental and cross functional teams such as study teams, CLINICAL PHARMACOLOGY leadership team, Journal club.
• Drives small teams with members from CLINICAL PHARMACOLOGY functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams.
• Authors scientific publications and present at national and international conferences and interact with KOLs/external stakeholders.
• Conducts due diligence assessments, summarizes results and represents CLINICAL PHARMACOLOGY on business development teams.
• Represents Clinical Pharmacology at regulatory meetings.

Requirements

• Associate Director, Clinical Pharmacology: PhD with typically 4+ years of experience or Pharm D with typically 6+ years of experience in a relevant field, Master’s Degree or equivalent education and typically 12+ years of experience, Bachelor’s Degree or equivalent education and typically 14+ years of experience; (*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)
• Senior Clinical Pharmacologist: PhD with 0 years of experience, or Pharm D with 2+ years of experience in a relevant field, Master’s Degree or equivalent education and typically 8+ years of experience, Bachelor’s Degree or equivalent education and typically 10+ years of experience; (*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)

Qualifications

• Excellent interpersonal skills
• Ability to interact with functional representatives and KOLs externally and internally and lead team(s)
• Strategic thinking and enterprise view
• Proven scientific track record and technical skills to perform the role

Skills

• Strategic thinking and enterprise view
• Excellent interpersonal skills
• Ability to interact with functional representatives and KOLs externally and internally and perform in a team setting
• Proven scientific track record and technical skills to perform the role

Benefits

• Covered medical/dental/vision insurance
• Comprehensive package of benefits including paid time off (vacation, holidays, sick), and 401(k)
• Participation in long-term incentive programs

Pay

$141,500 - $268,500 USD

Schedule

Primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.