Job Description

Join to apply for the Sr. Director Clinical Pharmacology role at Apex Systems

Job Description:

Senior Director, Clinical Pharmacology (Job #: 2063994)

Location:

Northeast (Remote)

Focus:

Oncology

Job Overview:

This role will lead strategies for innovative oncology therapies, ensuring regulatory progress and offering growth opportunities in a dynamic, small-team environment focused on significant unmet needs.

Primary Job Responsibilities:

1. Design pharmacokinetic (PK) and pharmacodynamic (PD) studies to transition drugs from research stages to market readiness.
2. Collaborate with Drug Metabolism and Pharmacokinetics (DMPK) teams to prepare and submit New Drug Applications (NDAs), focusing on precision in drug labeling.
3. Develop clinical pharmacology strategies for Phase 3 clinical trials, ensuring alignment with regulatory standards and expectations.
4. Provide expert clinical pharmacology insights to cross-functional teams, ensuring compliance in trial documentation and strategic regulatory interactions.

Primary Job Requirements:

1. PhD, MD, or PharmD with 8-10 years of experience in clinical pharmacology and oncology drug development.
2. Expert in IND to NDA drug development phases, with skills in clinical trial design, execution, and analysis.
3. Proficient in population PK/PD modeling, data analysis, and regulatory compliance, with familiarity in NDA processes.
4. Strong communicator with expertise in scientific writing and presentation, knowledgeable in ICH/GCP standards, prioritizing patient-centered approaches and quality.

About Stratacuity:

We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon inquiry, you may be contacted by a Stratacuity team member to discuss your career goals. We will not share your information without your prior consent.

Equal Employment Opportunity:

Stratacuity and Apex Systems are committed to equal opportunity employment and do not discriminate based on race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, veteran status, or any characteristic protected by law. Qualified applicants with criminal histories will be considered in accordance with applicable law.

Benefits and Resources:

We offer comprehensive benefits including health insurance, 401K, stock purchase plans, HSA, employee assistance programs, and professional development resources. Our dedicated support teams and career coaching are available to assist you.

Additional Information:

Join Apex Systems, part of ASGN Incorporated, and be part of a team that values innovation, collaboration, and continuous learning. We have received numerous awards for our workplace excellence.

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