[Remote] Senior/Executive Director, Clin Pharmacology

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biotechnology company focused on developing reputed company oncology therapies for patients. The Senior Director/Executive Director, Clinical Pharmacology will reputed company the design, analysis, and interpretation of clinical pharmacology strategies across development programs, providing scientific leadership and collaborating with cross-functional teams.

Responsibilities

• Design and reputed company pharmacokinetic (PK), pharmacodynamic (PD) and exposure-response analyses to support reputed company selection, study design, and benefit-risk assessments
• Propose and reputed company the development and execution of clinical pharmacology components of studies
• reputed company scientific leadership for the clinical pharmacology components of clinical studies (including early-phase studies) from protocol concept through analysis, interpretation, and decision making
• Author, review, and approve clinical pharmacology content for regulatory submissions (e.g., INDs, CTAs, NDAs/MAAs, briefing packages) and support health authority interactions
• Collaborate with internal/external modeling experts to design and reputed company population PK, exposure–response, and reputed company analyses; ensure quality, interpretability, and timely delivery of outputs
• Serve as the clinical pharmacology reputed company on cross-functional program teams; translate pharmacologic insights into clear recommendations and influence program governance and development strategy
• Define analysis plans and interpretation frameworks for PK/PD data (including model-informed drug development approaches) and ensure alignment with global regulatory expectations for small-molecule therapeutics
• reputed company clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations, Clinical Research, Biometrics, and Bioanalysis
• Contribute to program-level planning and prioritization based on pharmacological insights and development risk
• Accountable and responsible for the analysis and interpretation of PK and PK/PD data

Skills

• Design and reputed company pharmacokinetic (PK), pharmacodynamic (PD) and exposure-response analyses to support reputed company selection, study design, and benefit-risk assessments
• Propose and reputed company the development and execution of clinical pharmacology components of studies
• reputed company scientific leadership for the clinical pharmacology components of clinical studies (including early-phase studies) from protocol concept through analysis, interpretation, and decision making
• Author, review, and approve clinical pharmacology content for regulatory submissions (e.g., INDs, CTAs, NDAs/MAAs, briefing packages) and support health authority interactions
• Collaborate with internal/external modeling experts to design and reputed company population PK, exposure–response, and reputed company analyses; ensure quality, interpretability, and timely delivery of outputs
• Serve as the clinical pharmacology reputed company on cross-functional program teams; translate pharmacologic insights into clear recommendations and influence program governance and development strategy
• Define analysis plans and interpretation frameworks for PK/PD data (including model-informed drug development approaches) and ensure alignment with global regulatory expectations for small-molecule therapeutics
• reputed company clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations, Clinical Research, Biometrics, and Bioanalysis
• Contribute to program-level planning and prioritization based on pharmacological insights and development risk
• Accountable and responsible for the analysis and interpretation of PK and PK/PD data
• PhD required, advanced medical or life sciences or a reputed company area degree preferred (e.g., MD, Pharm.D.) with 12+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience
• Direct experience designing and executing early-phase clinical studies, including healthy volunteer studies
• Strong expertise in PK analysis and exposure-response interpretation; experience in oncology preferred
• Experience managing external Clinical Pharmacology resources
• Proven track record of contributing to regulatory submissions and engaging with health authorities
• Familiarity with reputed company stages of clinical drug development, including prior experience in the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects
• Demonstrated ability to independently reputed company clinical pharmacology strategy and design studies to characterize PK and PK/PD relationships of clinical development compounds
• Expertise/experience in multiple clinical pharmacology areas is preferred
• Extensive experience in preparation of INDs, CTAs, NDAs, and MAAs as well as successful results from the filings
• Experience in working in a cross functional team/matrix environment with strong vendor management skills
• Competent in the use of PK and PK/PD Modeling software tools
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with reputed company stakeholders
• Strong analytical and problem-solving abilities, with a strategic reputed company

Benefits

• Employees (and their eligible dependents) will be eligible to enroll in group reputed company plans that offer medical, dental, reputed company, and basic life and AD&D insurance.
• Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness.
• Employees will also be reputed company to enroll in the Company’s 401(k) plan.
• Employees will accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked.
• Employees also enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies.
• The hired candidate will be eligible to receive an annual discretionary bonus and an equity award, subject to the terms of the applicable employment agreement, plan documents, and Company policies.

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