Associate Director, Clinical Pharmacology

Found in: Resume Library US A2 - 1 week ago


Wilmington Delaware, United States Incyte Corporation Full time
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 on project teams. 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 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.

We Respect Your Privacy

Learn more at:

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 .

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 . 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).

Please contact (url removed) if you have any questions or concerns or would like to exercise your rights.


  • Sr. Director, Clinical Pharmacology

    Found in: Resume Library US A2 - 1 week ago


    Wilmington, Delaware, United States Incyte Corporation Full time

    Aperçu: 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,...

  • Sr. Director, Clinical Pharmacology

    Found in: Jooble US O C2 - 6 days ago


    Wilmington, DE, United States InCyte Full time

    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...

  • Associate Director, Drug Product Process Development

    Found in: Resume Library US A2 - 6 days ago


    Wilmington, Delaware, United States Incyte Corporation Full time

    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...


  • Wilmington, United States CareerBuilder Full time

    UNCW is wrapping up the public phase of a $125 million comprehensive campaign, and the Office of Annual Giving is growing its team to better serve the needs of University Advancement. The Associate Director of Annual Giving will serve as a trusted partner to the Director of Annual Giving and will be responsible for managing many of the day-to-day operations...

  • Associate Director, Fraternity and Sorority Life

    Found in: Talent US C2 - 7 days ago


    Wilmington, United States University of North Carolina Wilmington Full time

    Brief Summary of Work for this Position The Associate Director of Fraternity and Sorority Life serves as part of a team supporting, advising and advocating for a community comprised of four governing councils, 30+ nationally affiliated chapters and colonies made up of approximately 1,500 total students (10% of undergraduates). Reporting to the Director...


  • Wilmington, United States University of North Carolina Wilmington Full time

    The Director of the Honors College at UNCW serves to enrich, direct and support the Honors program while strengthening and sustaining a diverse Honors community among UNCWs students, faculty and staff. In serving this mission, the Director oversees Director, Diversity, Education, Clinical Research, Faculty, Program

  • US Medical Director

    1 week ago


    Wilmington, United States Workday Full time

    US Medical Director - Healthcare Innovation and Clinical Transformation - CVRM Introduction to role: As the US Medical Director - Healthcare Innovation and Clinical Transformation - Cardiovascular, Renal and Metabolism (CVRM), you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives by...

  • Center Medical Director

    Found in: Lensa US P 2 C2 - 3 days ago


    Wilmington, United States Oak Street Health Full time

    Company: Oak Street HealthTitle: Center Medical DirectorLocation: Wilmington , DERole Description:The purpose of the Center Medical Director role at Oak Street Health is to lead the clinical team at their center in providing the best patient care and a great place to work in order to keep patients happy, healthy and out of the hospital. The Medical Director...

  • Center Medical Director

    Found in: Lensa US P 2 C2 - 2 weeks ago


    Wilmington, United States Oak Street Health Full time

    DescriptionCompany: Oak Street Health Title: Center Medical Director Location: Wilmington Center - Wilmington, DERole Description: The purpose of the Center Medical Director role at Oak Street Health is to lead the clinical team at their center in providing the best patient care and a great place to work in order to keep patients happy, healthy and out of...

  • Director of Sales | Westin Wilmington

    Found in: Lensa US P 2 C2 - 3 days ago


    Wilmington, United States PM Hotel Group Full time

    What You'll Do: As a hotel, we offer a lot of different services: from catering to rooms to entertainment to banquets, we do it all. And we need someone to help us get the word out. As the Director of Sales and Marketing, you'll oversee all sales fun Director, Sales, Sales Associate, Hotel


  • Wilmington, United States Highmark Full time

    This job leads a physician team and ensures that utilization management responsibilities are performed in accordance with the highest and most current clinical standards. The incumbent oversees a team of Medical Directors who are responsible for revi Medical Director, Director, Health, Medical, Senior, Operations, Healthcare

  • Family Practice

    Found in: Careerbuilder One Red US C2 - 2 days ago


    Wilmington, Delaware, Wilmington, Delaware, 19801, United States RecruitWell Full time

    Family Practice physician job in Delaware : Wilmington, Delaware, Medical Director - Geriatric Medicine Physician Opening Clinical Role: Seeking a physician Board Certified or Board Eligible in Geriatrics, Internal Medicine, or Family Medicine BLS, CDS Certification, and DEA - Required Minimum of 1 year experience working with the frail or elderly...


  • Wilmington, United States Pivot Physical Therapy Full time

    Position Overview: Greater Purpose and Core Values: Athleticos Greater Purpose is to empower people, inspire hope and transform lives. We accomplish this by providing exceptional, progressive, and cost-effective fitness, performance and rehabilitative services through personalized care that emphasizes education and prevention of future injury. This is...

  • Director, Perioperative Business Operations

    Found in: Talent US C2 - 1 week ago


    Wilmington, United States Nemours Children\'s Health Full time

    Nemours is seeking a Director, Perioperative Business Operations for our Wilmington, DE location. Primary Functions:  The Perioperative Services Business Director is responsible for providing organization, planning, direction, and coordinated administration for the operating rooms at NCH‐Delaware, Deptford ambulatory surgery center (ASC) and Malvern...


  • Wilmington, United States Nemours Full time

    Nemours is seeking a Director, Perioperative Business Operations for our Wilmington, DE location. Primary Functions: The Perioperative Services Business Director is responsible for providing organization, planning, direction, and coordinated administration for the operating rooms at NCH‐Delaware, Deptford ambulatory surgery center (ASC) and Malvern...


  • Wilmington, United States NFI Full time

    The Director of Corporate Security Services (CSS) will report to the Vice President of CSS. The Director will be responsible to support and direct NFI’s administrative strategy and programs for North America. The Director is a key leader among the CSS team. The Director will help support a culture and conduct of security collaboration throughout the NFI...


  • Wilmington, United States CareerBuilder Full time

    Director of Enterprise Fraud Risk Management page is loaded Director of Enterprise Fraud Risk Management Apply locations Wilmington, DE time type Full time posted on Posted 2 Days Ago job requisition id R-101399 Job Description At WSFS Bank, we empower our Associates to grow their careers, guide our customers to secure their financial futures, and actively...


  • Wilmington, United States Workday Full time

    At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. As the Associate Director of Reporting Strategy & Design, you’ll be accountable for supporting the Reporting & Analytics needs for Respiratory, Immunology and Vaccine sales teams in the US...

  • Director of Nursing

    2 weeks ago


    Wilmington, United States The Mary Campbell Center Full time

    Job DescriptionJob DescriptionThe Mary Campbell Center is first, last, and always home to 68 residents. The Director of Nursing (DON) is responsible for leading The Center's health care professional team in achieving a truly homelike environment in which MCC residents live with respect, personal dignity, and independence to the fullness of their...

  • Division Chief, Pediatric Hematology/Oncology

    Found in: Jooble US O C2 - 1 week ago


    Wilmington, DE, United States American Society of Clinical Oncology (ASCO) Full time

    Nemours Children’s Health seeks a renowned and accomplished physician scientist to become the new Division Chief, Pediatric Hematology/Oncology/Bone Marrow Transplant (BMT). The new Division Chief, reporting to the Chair of Pediatrics, will lead the division, serve as Director of the Moseley Foundation Institute for Cancer and Blood Disorders and hold the...