Associate Director, CPP Lead

Scorpion Therapeutics; United States; Remote; USD 130,000 - 180,000; Full time

Job summary

A leading biopharmaceutical company is seeking an experienced clinical pharmacology leader to join their Clinical Pharmacology & Pharmacometric organization. This role involves overseeing clinical pharmacology activities, collaborating with various teams, and advancing drug candidates through development phases. The ideal candidate will have a Ph.D. or MD with extensive experience in clinical development and a strong publication record.

Qualifications

• 7-10 years experience in clinical development teams.
• Hands-on experience with PPK, ER or PBPK analyses.
• Appropriate publication record in peer-reviewed journals.

Responsibilities

• Develop and implement CPP strategies across drug development phases.
• Provide guidance on pharmacometric analyses and dosing paradigms.
• Collaborate with cross-functional teams to support development projects.

Skills

Communication

Collaboration

Influence

Education

Ph.D. or MD

Tools

NONMEM

R

SimCYP

GastroPlus

Job description

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Overview

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary Function)

We are seeking an experienced clinical pharmacology leader to join our Clinical Pharmacology & Pharmacometric organization in Translational Medicine. This individual is a leader in the field of CPP, with integrated and deep understanding of drug development. You will play a crucial role in leading and overseeing the clinical pharmacology & pharmacometric activities on project teams. You will be responsible for providing, scientific leadership in a collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.

Essential Functions Of The Job (Key Responsibilities)

• Develop and implement the CPP strategies across program, indication and study levels, including strategies for Phase I -III drug development.
• Provide guidance in interpreting the data from pharmacometric analyses, including PPK, exposure-response analyses, and other quantitative analyses, to recommend dosing paradigm for different phases of clinical development; provide justification for dose selection for pivotal clinical trials.
• Liaise with biologists and preclinical scientists to come up with structural models for particular mechanisms as applies to clinical development; collaborate with BioStats, Data Management, Clinical Operations & Medical to support development projects.
• Generate reports for NCA PK, population PK and exposure-response analyses, author (s)NDA/(s)BLA summary dossiers, contribute to background document sent to regulatory authorities to support milestone meetings (e.g EOP2).
• Present data and recommendations to global program teams, external collaborators and senior management.
• Stay current with scientific advancements and regulatory trends in clinical pharmacology and Pharmacometrics, and apply the knowledge to advance drug discovery and development for the organization; Publish in peer reviewed journals.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Ph.D. or MD with 7 to 10 years or more of experience in appropriate disciplines that lay the foundation for the job functions detailed above; Prior successful experiences on clinical development teams delivering enabling clinical PK and clin pharm analyses.
• Excellent communication skills and ability to effectively collaborate with cross-functional teams and influence decision-making process; Preferred hands on experience with PPK, ER or PBPK analyses and reporting, and experience using NONMEM, R, SimCYP or GastroPlus, or other programs.
• Strength in delivering results on agreed timelines in advancing pipeline.
• Experience working in a matrix environment.
• Appropriate publication record in top-tier and peer-reviewed journals is required.

Disclaimer

The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

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