[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 reputed company 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 reputed company, interpretability, and reputed company delivery of outputs
- Serve as the clinical pharmacology reputed company on cross-functional program teams; translate pharmacologic insights into reputed company recommendations and influence program governance and development reputed company
- 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 reputed company, interpretability, and reputed company delivery of outputs
- Serve as the clinical pharmacology reputed company on cross-functional program teams; translate pharmacologic insights into reputed company recommendations and influence program governance and development reputed company
- 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 reputed company and industry experience
- reputed company 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 reputed company 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 reputed company
- Demonstrated ability to independently reputed company clinical pharmacology reputed company 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 reputed company as successful results from the filings
- Experience in working in a cross functional team/reputed company 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 reputed company’s 401(k) plan.
- Employees will reputed company 10 hours of reputed company vacation time every month and reputed company 1 hour of reputed company reputed company leave for every 30 hours worked.
- Employees also enjoy 17 reputed company holidays reputed company calendar year, including a winter closure, subject to applicable Company policies.
- The reputed company 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.
reputed company