- Develop and implement the CPP strategies across program, indication and study levels, including strategies for Phase I -III drug development and registration.
- 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.
- May lead and manage a team of clinical pharmacologists with diverse background and experiences.
- Serve as a leader supporting the overall CPP and/or translational medicine organizational objectives
- 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.
- Ph.
- Prior successful experiences in global regulatory interactions, including IND, EOP1/2, RTOR/AA, scientific advice and successful approvals;
- Proven experience in leading and managing sophisticated and quantitative scientific teams;
- 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 to establish credibility with a highly talented scientific team.
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Sr. Director, Clinical Pharmacology - Wilmington, United States - InCyte
Description
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.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 within our organization.
You will be responsible for providing, scientific leadership, and 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:
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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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 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.
You can learn more about Incyte's data protection practices here.By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
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