Sr. Principal/Assoc. Scientific Director, Pharmacometrics
Scorpion Therapeutics, Rancho Santa Fe, California, United States
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Role Summary The Sr. Principal/Assoc. Scientific Director, Pharmacometrics leads pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation (M&S) efforts that drive the clinical development of Neurocrine’s small‑and‑large‑molecule programs. The role provides strategic PK/PD methodology expertise, performs or oversees pharmacometric analyses, and communicates findings to cross‑functional stakeholders. It contributes to the design and execution of the Clinical Pharmacology and Pharmacometrics Development Plan and mentors colleagues to advance excellence within the function.
Responsibilities
Lead pharmacometrics tasks and serve as function lead for assigned clinical development programs; recommend strategic direction for modeling and simulation activities.
Independently conduct and report population PK, PK/PD, and Exposure‑Response analyses to support dose selection, trial design, and regulatory submissions.
Oversee design and reporting of M&S analyses conducted by external CROs.
Contribute to M&S sections for internal decision‑making boards, regulatory documents, interactions, and responses.
Prepare posters, publications, and presentations for internal and external conferences in quantitative pharmacology and pharmacometrics.
Mentor and may direct projects of critical importance; perform other duties as assigned.
Qualifications
PhD, PharmD, or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with 5+ years of drug development experience post PhD/PharmD, OR MS with 8+ years of Pharmaceutical/Biotech industry experience.
Expert knowledge in conduct and/or oversight of early and late‑stage Modeling and Simulation activities.
In‑depth knowledge of all stages of clinical drug development, including preparing components of Clinical Pharmacology sections of regulatory submissions for IND‑ and NDA‑stage projects.
Proficient with PK and PK/PD modeling software tools including NONMEM, R, and WinNonlin.
Significant expertise in preparing NDA/MAA summaries of population modeling analyses would be highly beneficial.
Strong communications, problem‑solving, analytical thinking, and influencing skills.
Ability to work within a matrix, cross‑functional team; discuss changes, progress, and issues as they relate to other areas.
Leadership and mentoring abilities; typically leads lower levels and/or indirect teams.
Ability to meet multiple deadlines across various projects with high accuracy and efficiency; excellent project management and leadership skills.
Education
PhD, PharmD, or equivalent in a related field; or MS with substantial industry experience in pharmacometrics.
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Role Summary The Sr. Principal/Assoc. Scientific Director, Pharmacometrics leads pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation (M&S) efforts that drive the clinical development of Neurocrine’s small‑and‑large‑molecule programs. The role provides strategic PK/PD methodology expertise, performs or oversees pharmacometric analyses, and communicates findings to cross‑functional stakeholders. It contributes to the design and execution of the Clinical Pharmacology and Pharmacometrics Development Plan and mentors colleagues to advance excellence within the function.
Responsibilities
Lead pharmacometrics tasks and serve as function lead for assigned clinical development programs; recommend strategic direction for modeling and simulation activities.
Independently conduct and report population PK, PK/PD, and Exposure‑Response analyses to support dose selection, trial design, and regulatory submissions.
Oversee design and reporting of M&S analyses conducted by external CROs.
Contribute to M&S sections for internal decision‑making boards, regulatory documents, interactions, and responses.
Prepare posters, publications, and presentations for internal and external conferences in quantitative pharmacology and pharmacometrics.
Mentor and may direct projects of critical importance; perform other duties as assigned.
Qualifications
PhD, PharmD, or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with 5+ years of drug development experience post PhD/PharmD, OR MS with 8+ years of Pharmaceutical/Biotech industry experience.
Expert knowledge in conduct and/or oversight of early and late‑stage Modeling and Simulation activities.
In‑depth knowledge of all stages of clinical drug development, including preparing components of Clinical Pharmacology sections of regulatory submissions for IND‑ and NDA‑stage projects.
Proficient with PK and PK/PD modeling software tools including NONMEM, R, and WinNonlin.
Significant expertise in preparing NDA/MAA summaries of population modeling analyses would be highly beneficial.
Strong communications, problem‑solving, analytical thinking, and influencing skills.
Ability to work within a matrix, cross‑functional team; discuss changes, progress, and issues as they relate to other areas.
Leadership and mentoring abilities; typically leads lower levels and/or indirect teams.
Ability to meet multiple deadlines across various projects with high accuracy and efficiency; excellent project management and leadership skills.
Education
PhD, PharmD, or equivalent in a related field; or MS with substantial industry experience in pharmacometrics.
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