Associate Director/Director-Global Clinical Pharmacology (Florham Park)HUTCHMED • Florham Park, NJ, US
Associate Director / Director-Global Clinical Pharmacology (Florham Park)
HUTCHMED • Florham Park, NJ, US
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.part_time]
[job_card.job_description]Accountable and responsible for the Clinical Pharmacology support for the HUTCHMED global portfolio Provide scientific insights that drive global clinical development decisions and support global regulatory submissions Responsible for ensuring appropriate Clinical Pharmacology representation on drug / dosage form development and clinical teams and provision of PK / PD expertise and leadership to a project The incumbent will complete assigned work in a resourceful, self-sufficient manner and will be able to create alternative approaches to achieve desired results if needed Responsible for ensuring planning and direction of Clinical Pharmacology components of clinical programs (including clinical development plan / life cycle plan) and studies (including synopsis and protocol preparation; clinical phase oversight, reporting) Responsible for ensuring leadership of multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and ensuring overall scientific accountability for the designated studies Responsible (with members of Clinicians and Statisticians) for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses in first in human studies and dosage regimens in patients Responsible for summarizing and interpreting results of pharmacokinetic, pharmacodynamic analyses with respect to their impact on development and clinical use of drugs During the pre-clinical stages of drug development, works with Drug Discovery team to ensure that sufficient preclinical PK / PD knowledge exists to support progression into first in man studies Accountable for ensuring that there are valid methods for measuring drug and metabolite concentrations (or any biochemical biomarkers) in human studies Coordinates with medical writers (and other team members) in the data review, analysis and reporting of the Clinical Pharmacology study Responsible, in conjunction with medical writer, for overall content and accuracy of study report before forwarding for final sign-off. Assist with internal and external dissemination of results to Development Team, Investigators etc. Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the Clinical and Development teams and in regulatory documentation such as labeling Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource of clinical pharmacology and therapeutics knowledge in terms of both medical background and clinical trial design Participates in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management Acts as technical lead for specific development projects, Phase I / III and Clinical Pharmacology centric studies Manage and initiate external collaborations with leaders in clinical pharmacology and Key Opinion Leaders PhD in clinical pharmacology, quantitative pharmacology, pharmacokinetics, or related field / MD / PharmD preferred Biologics including monoclonal antibody, bispecific antibody, and antibody-drug conjugate experience is preferred Experiences in Oncology / Autoimmune disease field is preferred Proven expertise in pharmaceutical / biotech industry (8-15 years) with adequate knowledge in ICH guidelines, Good Clinical Practice applicable to Clinical Pharmacology Direct experience with clinical pharmacology summary documents required for Regulatory submissions Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization Experience in clinical development and new drug registration Mastery of statistics applied to clinical research Ability to work with pharmacometrician for PopPK modeling, E-R analysis, PBPK, and PK-PD modeling, and interpret the data to support the clinical development Good ability to interpret complex clinical data and experimental results Ability to develop network internally and externally to communicate in situations requiring special tact and diplomacy Self-motivated and self-disciplined individual with superb problem-solving and leadership skills Excellent English (writing and speaking) and excellent mastery of English medical terminology Knowledge of FDA, EMA and ICH guidelines and regulations Record of successful publications in the area of clinical pharmacology / pharmacometrics Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization. Prior direct interaction with regulatory agencies and advisory boards is required Candidate must demonstrate thorough understanding of principles of clinical pharmacology including clinical study design, analysis, and interpretation, and application of these approaches to drug development, guidelines in the design of clinical trials and development plans Ability to organize and work simultaneously on multiple projects Ability to work in a matrix, project-oriented environment Excellent written and oral communication skills, interpersonal / influencing skills, and ability to work in a continually changing environment Supports the success of a group being led by providing clarity, support and tools needed to excel as things change Maintains a functional, perspective and acts on the belief that solutions and plans are stronger when appropriate collaboration occurs across and beyond the organization Actively builds relationships and networks with others across and beyond HUTCHMED working constructively across organizational boundaries despite differences in interests, perspectives and need
PRIMARY FUNCTION
- Associate Director / Director plays a key role as clinical technical lead on global Phase I-III and other clinical pharmacology centric projects
- Serves as a team member supporting multiple facets of Clinical Pharmacology, including study design, PK and PK / PD analyses, and overall drug development support. This position is also the scientific and medical / clinical liaison between internal teams and external groups such as clinical operations, vendors (CROs, central laboratories, etc.), investigators, medical monitors, regulatory authorities, medical affairs, commercial, Key Opinion Leaders, Advisory Boards
- The candidate will have an excellent knowledge of Clinical Pharmacology principles, such as PK, PK / PD, drug metabolism, drug-drug interactions, PBPK, PopPK modeling and E-R analysis. Provides peer-reviewed interpretation of clinical pharmacology data and incorporates appropriate analyses into reports required for regulatory submissions
MAJOR RESPONSIBILITIES AND DUTIES
MINIMUM REQUIREMENTS
PREFERRED SKILLS AND EXPERIENCE :
KEY COMPETENCIES :
[job_alerts.create_a_job]
Clinical Pharmacology • Florham Park, NJ, US
[internal_linking.similar_jobs]
As our Clinical Development Director in Cardiology you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data...[show_more]
The Associate Director, Commercial Analytics, will serve as a key client-facing leader within KMK's Commercial Analytics Center of Expertise.
This role combines strategic account management with han...[show_more]
About Axtria Axtria is a global leader in cloud software and data analytics for the Life Sciences industry, empowering organizations to transform their product commercialization journey and i...[show_more]
The Technical Director supports the Clinical disciplines of the laboratory such as Chemistry, Hematology, Microbiology, Specialty Testing, and Blood Bank to produce high-quality consistent and time...[show_more]
LocumJobsOnline is working with CompHealth to find a qualified Anesthesiology MD in New Brunswick, New Jersey, 08901!.Come practice in this great location in New Jersey surrounded by multiple commu...[show_more]
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable i...[show_more]
Pathology physician job in New Jersey : .Job Reference Id : ORD-201975-MD-NJ.Dates Needed : November 24 - June 28, FT.Board Certification Required : Yes.
A facility in New Brunswick, NJ is looking fo...[show_more]
We’re a physician-led, patient-centric network committed to simplifying health care and bringing a more connected kind of care.
Our primary, multispecialty, and urgent care providers serve millions ...[show_more]
FlexCare is seeking an experienced Nuclear Medicine Technologist for an exciting Travel Allied job in New Brunswick, NJ.Shift : 4x10 hr days Start Date : 12 / 22 / 2025 Duration : 13 weeks Pay : $3042.Leve...[show_more]
Well established multi-office pediatric practice looking for.Pediatric NP or PA to work either FT or part-time (30 hrs per week) in our East Brunswick office.
Friendly pediatric specific EMR in use ...[show_more] The Department of Neurology at Rutgers Robert Wood Johnson Medical School (RWJMS) in New Brunswick, NJ is seeking an accomplished physician-leader to serve as.
Division Chief of Stroke and Neurocrit...[show_more] 
The Associate Director, Commercial Analytics, will serve as a key client-facing leader within KMK's Commercial Analytics Center of Expertise.
This role combines strategic account management with han...[show_more]
As a leading Contract Development and Manufacturing Organization (CDMO), Ardena partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—united by the mi...[show_more]
Description : Who is Harmony Health GroupHarmony Health Group was founded in 2015 with the mission of providing a safe, supportive, and therapeutic environment for individuals struggling with substa...[show_more] Accountable for all country clinical / medical aspects associated with programs / trials by providing clinical strategic and tactical leadership.
Informed Consent Forms (ICFs) and other relevant clinica...[show_more] 
Reporting to the Head of Finance, Global Manufacturing & Supply, the Sr.Director, Finance Lead Biologics Manufacturing will be responsible for the Platform Finance organization, including oversight...[show_more]
Hybrid schedule with flexibility and excellent benefits!.This Jobot Job is hosted by : Doug Goldman.Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary...[show_more]
Company Overview KMK Consulting Inc.Commercial Analytics, Sales Planning & Operations, and HEOR|RWE.We partner with pharmaceutical and biotech clients to transform complex data into strat...[show_more]
(Associate) Clinical Development Director
Novartis Group Companies • East Hanover, NJ, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Associate Director, Advanced Analytics (Morris Plains)
KMK Consulting Inc. • Morris Plains, NJ, US
[job_card.part_time]
[last_updated.last_updated_30] • [promoted]
Associate Director / Director - RWE (1221)
Axtria, Inc. • Berkeley Heights, NJ, US
[job_card.full_time]
[filters_job_card.quick_apply]
[last_updated.last_updated_variable_days]
Director Clinical Microbiology
Atlantic Health • Morristown, NJ, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Physician (MD / DO) - Anesthesiology - General / Other - $560,000 to $580,000 per year in New Brunswick, NJ
LocumJobsOnline • New Brunswick, NJ, US
[job_card.full_time] +1
[last_updated.last_updated_30] • [promoted]
Associate Director, Regulatory Affairs CMC - Hybrid Onsite
Allergan • Florham Park, NJ, United States
[job_card.full_time]
[last_updated.last_updated_variable_hours] • [promoted] • [new]
Pathology
LocumTenens.com • New Brunswick, New Jersey, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Director of Molecular Pathology
HealthEcareers - Client • Woodland Park, NJ, USA
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Travel Nuclear Medicine Technologist - $3042.4 / Week
FlexCare • New Brunswick, NJ, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
MD / NP / PA
Ivy Pediatrics, PA • East Brunswick, NJ, US
[job_card.full_time] +1
[last_updated.last_updated_30] • [promoted]
Division Chief of Stroke and Neurocritical Care
HealthEcareers - Client • New Brunswick, NJ, USA
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Associate Director, Advanced Analytics
KMK Consulting Inc. • Morris Plains, NJ, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Associate Director Analytical Research & Development
Ardena • Somerset, New Jersey, US
[job_card.full_time]
[filters_job_card.quick_apply]
[last_updated.last_updated_variable_hours] • [new]
Clinical Director
Harmony Health Group • Union, New Jersey, United States
[job_card.full_time] +1
[last_updated.last_updated_variable_hours] • [promoted] • [new]
(Associate) Clinical Development Medical Director
Novartis Group Companies • East Hanover, NJ, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Sr. Director, Finance Lead Biologics Manufacturing
Zoetis, Inc • Parsippany, NJ, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Director, FP&A
Jobot • Woodbridge Township, NJ, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Associate Director, Advanced Analytics
KMK Consulting, Inc. • Morris Plains, NJ, US
[job_card.full_time]
[filters_job_card.quick_apply]
[last_updated.last_updated_30]