Associate Director, Clinical Pharmacology (Immunology)

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience—and products and services in our Allergan Aesthetics portfolio.

About the role

Conceives, executes, and effectively manages and communicates multi-disciplinary Clinical Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD study proposals and leads those efforts. Anticipates and critically evaluates Clinical Pharmacology, PK/PD, or regulatory advances, strengths, weaknesses, opportunities, and threats, and responds with appropriate new strategies. Consistently demonstrates an excellent record of accomplishment of Clinical Pharmacology and business objectives. Leads Clinical Pharmacology/PK/PD aspects of multiple projects and is responsible for critically evaluating technical and scientific aspects along with Clinical Pharmacology and Pharmacometrics management.

Responsibilities

• Accountable for Phase 1-4 studies design and clinical pharmacology strategy; acts as the representative for project(s).
• Executes strategy, leads teams, and performs 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 the research question).
• Authors regulatory documents including protocols, study reports, population PK reports, exposure-response analyses reports, CTDs, label sections, relevant sections of investigator brochures, white papers, and other similar documents.
• Leads clinical pharmacology and biopharmaceutics meetings, serves as CLINICAL PHARMACOLOGY representative at Clinical Strategy Team/Asset Development Team, and presents at various departmental and cross-functional teams such as study teams, CLINICAL PHARMACOLOGY leadership team, and 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 presents at national and international conferences, interacting with KOLs/external stakeholders.
• Conducts due diligence assessments, summarizes results, and represents CLINICAL PHARMACOLOGY on business development teams.
• Represents Clinical Pharmacology at regulatory meetings.

Qualifications

• PhD with typically 4+ years of experience or PharmD 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).
• 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

• Delivers business results while also positioning AbbVie for long-term success.
• Persistent and resilient; finds the way to move good ideas forward.
• Acts respectfully yet courageously.
• Connects unrelated concepts, generates original or unique ideas.
• Influences colleagues to achieve cross-functional alignment.
• Gives full accountability when delegating and accepts full accountability when delegated to by others.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) to eligible employees.
• Eligibility to participate in long-term incentive programs.