Senior Director, Clinical Pharmacology 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:

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

Primary Job Requirements:

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

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.