Intern, Clinical Pharmacology Job at BioMarin Pharmaceutical

Oncology Early-Stage Clinical Scientist

You will lead and coordinate the development of multiple studies of novel biolog...

Location

United States , Cambridge; La Jolla; Bothell; Groton; New York City

Salary:

176600.00 - 282900.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

Relevant PhD or PharmD and a minimum of 5 years of experience in a similar role in industry/CRO
MS and a minimum of 7 years of experience in a similar role in industry/CRO
BA/BS and a minimum of 10 years of experience in a similar role in industry/CRO
Clinical Research experience in Phase 1 in Oncology, on the side of the sponsor leading studies
Experience in or strong understanding of Oncology Drug Development especially in Early Development
Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
Strong scientific writing skills and communication skills (written and verbal)
Clinical document writing experience (e.g., protocol, ICD, IB, IND), as well as understanding complex data analysis
Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations
Experience working with and solid understanding of related disciplines, e.g., Clinical Operations, Data Management, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance

Job Responsibility

Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s)
Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results
Support execution for all FIH programs through proof-of concept
Set the clinical data review strategy, ensure quality data and conduct review of emerging clinical data and trends
review and query data
present and discusse relevant data to appropriate teams, governance bodies, and other internal and external stakeholders
Conduct data review, analysis and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics
Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
Support and assist in the development of publications, abstracts, and presentations
May sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials

What we offer

Eligibility for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility

Fulltime

Clinical Study Team Assistant

As a part of the global Project Leadership group at Parexel, you are responsible...

Location

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor’s Degree (B.S. or B.A.) in either a Scientific or Business-related field preferred or equivalent relevant experience
Minimum 2 - 3 years experience in clinical administration in pharmaceutical or clinical research environment
Solid experience in TMF
Experience in WORD, EXCEL, PowerPoint, other software and system
Fundamental understanding of filing systems and organizational tools
Proficiency in written and spoken English
Able to independently prioritize multiple key activities, collaborate effectively with various levels of seniority on the study team and across the organization and efficiently ensure completion of tasks per timelines to required quality standards
Able to work independently and proactively to anticipate team needs related to clinical trial services
Demonstrated effectiveness working with multiple functions in a professional manner
Effective verbal and written communication skills relating to colleagues and associates both inside and outside the organization

Job Responsibility

Provide Client Trial Master File (TMF) support and maintenance – file & ensure documents are in the TMF
Input into the set- up of TMF document list and maintains relevant clinical trial documents according to International Conference on Harmonization-Good Clinical Practices (ICH-GCP) and Standard Operation Procedures (SOPs), including archiving and electronic filing of documents (TMF)
Accountable for analyzing, interpreting and evaluating clinical trial documentation to determine appropriateness for inclusion into the TMF
Evaluate TMF compliance and raise findings to Study Manager (SM)
Files and tracks documents for the study in collaboration with the document owner
Collaborates with the TMF Study Owner for issues or problems to be addressed and to create and manage placeholders
Ensures resolution of Quality Control (QC) findings (as delegated) to support final archive of the clinical study documents
Maintain, verify, process, and makes updates to Client systems (including Registry), spreadsheets/documents as needed
For Early Development and some small/single country studies may be required to: Coordinate Clinical Study Agreement approvals to ensure timely site initiation
Responsible for coordinating the clinical trial application to ethics committee and regulatory authority

What we offer

Supportive work environment
High degree of empowerment and accountability
Work with a diverse set of clients and therapeutic areas
Encouraged to take on new challenges and pursue your interests
Supportive and inclusive environment
Flexible work arrangements
Remote, in-office and hybrid roles
Varied project experience
Career progression

Fulltime

Medical Director/Senior Medical Director, Clinical Development, Genetic Diseases

The Medical Director in Clinical Development will serve as the Medical Lead for ...

Location

United States , Cambridge

Salary:

210000.00 - 375000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

MD, DO or equivalent ex-US medical degree with 15+ years experience
Minimum of 4 years of Pharmaceutical/Biotech industry experience in clinical development and medical monitoring
Board certification/eligibility in endocrinology or metabolic disorders, or another relevant specialty highly desired
Strong oral and written communication skills to influence others
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
Clinical development and/or clinical experience in rare disease, cell & gene therapy is a plus
Ability to work independently to resolve challenges

Job Responsibility

Serves as the Clinical Development lead on the cross-functional Program Team and co-lead the Clinical Development Sub-team for assigned programs
Support development of Target Product Profile (TPP) and Clinical Development Plan (CDP)
Serves as the medical monitor for assigned studies including design, execution and interpretation study data
Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology and biomarker analysis plans
Ensure patient safety on clinical trials and adherence to Good Clinical Practices (GCP)
Contribute to the development of regulatory documents in support of regulatory submissions, including clinical section of IND's and CTA's, safety reports, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
Acts as liaison between Clinical Development and other internal groups at BEAM for assigned studies
Establishes strong collaborations with study investigators, outside medical experts and represents BEAM during investigator meetings and advisory boards
Contribute to the development and planning of Advisory Board meetings in the relevant therapeutic areas

Fulltime

Senior Manager, Pharmacometrics and Data Sciences

Cencora is seeking a Senior Manager, Pharmacometrics and Data Sciences to apply ...

Location

United States of America

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Pharm D or Ph.D. in Pharmaceutical Sciences or Biomedical Engineering, with specialization in pharmacometrics
A Master’s degree with substantial relevant experience will also be considered
3-5 years of experience in pharmacometrics within the pharmaceutical or biotechnology industry
Demonstrated expertise in population PK/PD modeling, exposure-response analysis, and clinical trial simulations
Proficiency in pharmacometric software (essentially NONMEM and R, PKanalyx or Phoenix Winonlin)
Strong analytical and problem-solving skills
Good written and verbal communication skills
Organizational and project management skills
Knowledge of the pharmaceutical industry, including preclinical and early clinical development and the underlying pharmacometrics issues
Minimum knowledge of basic of IT

Job Responsibility

Development, execution and interpretation of pharmacometric analyses, including population PK and PK/PD models, Non-Compartmental Analysis (NCA), exposure-response modeling, clinical trial simulations
Develop and validate pharmacometric models to support dose selection, trial design, and decision-making
Analyze and interpret complex pharmacokinetic (PK) and pharmacodynamic (PD) data, integrating results with clinical and preclinical data
Author and review technical protocols, analysis plan, reports and scientific publications. Review regulatory documents in area of expertise
Propose innovative quantitative pharmacology approaches and optimize modeling processes
Collaborate with clinical pharmacology, biostatistics, regulatory, and clinical development teams to align pharmacometric strategies with program objectives
Communicate modeling results and their implications to cross-functional teams and senior management
Represent the company in meetings with academic institutions and industry forums as a pharmacometric subject matter expert
Oversee multiple pharmacometric projects, ensuring timely delivery of high-quality outputs
Ensure contact with the client

What we offer

medical
dental
vision care
comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave
variety of training programs
professional development resources
opportunities to participate in mentorship programs, employee resource groups, volunteer activities

Fulltime

Statistician - Pharmacokinetics

Contract Pharmacokinetics Statistician – Phase I PK Analysis (Zero Hours Contrac...

Location

United Kingdom

Salary:

Not provided

Quanticate

Expiration Date

Until further notice

Requirements

MSc (or equivalent experience) in Statistics, Pharmacometrics, Pharmaceutical Sciences, or a related discipline
Strong understanding of pharmacokinetic principles and Phase I clinical study design
Working knowledge of non-compartmental PK analysis methods
Familiarity with PK regulatory expectations and reporting standards
Typically 8–10 years supporting PK analyses within pharmaceutical, biotechnology, or CRO environments
Demonstrated experience analysing Phase I PK data and contributing to reporting
Proven experience performing QC and peer review of PK outputs
Experience working in consultancy or contract-based delivery models is advantageous
Proficiency in SAS and/or R for PK analysis
Familiarity with PK software such as Phoenix WinNonlin is beneficial but not essential

Job Responsibility

Perform standard non-compartmental pharmacokinetic analyses for Phase I clinical studies
Generate and review PK parameters including Cmax, Tmax, AUC, and half-life
Contribute to PK tables, listings, figures, and summary outputs for clinical study reports
Support analyses across SAD, MAD, and food-effect study designs
Assist with dose proportionality and exploratory PK comparisons where required
Ensure appropriate handling of below-quantification-limit (BQL) data according to SAP guidance
Conduct independent quality control of PK datasets and analysis outputs
Peer review analyses performed by other statisticians or programmers
Document QC findings clearly and support issue resolution in line with SOPs and good statistical practice
Review PK components of protocols and SAPs to confirm feasibility and internal consistency

Director/Senior Director of Clinical Research

Join Hemab, a clinical-stage biotech company, on an exciting journey to build th...

Location

Denmark , København

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Advanced degree (MD, PhD, PharmD) in life science or health science field
5+ years in clinical development within biotech/pharmaceutical industry or equivalent professional experience
Proven track record executing Phase I-III clinical trials
Strong understanding of regulatory environment and experience with regulatory interactions
Extensive knowledge of GCP, clinical trial methodology, clinical processes, and regulatory requirements
Demonstrated leadership with strong strategic and analytical thinking abilities
Excellent communication and presentation skills
Collaborative approach with ability to work across functions
Strong organizational skills and ability to manage multiple priorities
Comfortable in fast-paced biotech environment

Job Responsibility

Develop clinical development strategies, study designs, and protocols that meet scientific and regulatory objectives
Oversee clinical trial documentation and study execution, including endpoint selection, medical monitoring, and clinical trial data review/interpretation
Monitor program progress and develop contingency plans as needed
In collaboration with Clinical Operations, responsible for oversight of study enrolment and timelines for key deliverables
Collaborate with Discovery teams to identify and interrogate new drug candidates
Support regulatory submissions and documentation
Ensure adherence to GCP, ICH guidelines, and company policies
Work closely with Clinical Operations, Clinical Science, Biostatistics, Regulatory Affairs, Medical Affairs, Quantitative Clinical Pharmacology and Safety/Pharmacovigilance teams to generate and deliver high-quality clinical data to support scientific and corporate objectives
Partner with key opinion leaders and subject matter experts to support study design and strategic elements of the CDP
Manage relationships with clinical study sites/investigators, CROs, vendors, and consultants

Fulltime

Associate Director Medical Writer

The Associate Director Medical Writer is an individual expert who can manage and...

Location

Canada , Mississauga

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

PhD or relevant working experience within the life sciences space
Proven track record in writing clinical/regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions
Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements
Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide
Demonstrated effectiveness in management of projects of increasing scope and complexity
Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome)
Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions
High-level computer skills and general computer literacy
Demonstrated knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research
Ability to interpret clinical data, assess trends and patterns in text and statistical data, and effectively organize content and messages in clinical reports and summary documents

Job Responsibility

Contribute to the planning, authoring, review, and approval of clinical/regulatory documents for medical writing project to achieve a successful outcome within the required timelines
Possess highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at a senior level
Provide major input to submission teams in development of submission plans, timelines, document content and dependencies
Advises on or recommends methods for achieving accelerated timelines, including review tools and automation
Actively contribute to development of training materials for clinical document preparation
provides mentoring and/or training on clinical documentation and submission planning to individuals or teams
Champion change and contributes to departmental or cross-functional process improvement initiatives and develops/revises standards for GSK submission documents
Effectively contribute to process improvement activities

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Ophthalmic Tech 4

The Diagnostic Technician is responsible for performing state-of-the-art diagnos...

Location

United States of America , Rochester

Salary:

24.22 - 31.49 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

High school diploma required
1-2 years of closely related clinical experience or training/coursework in optometry, ophthalmology or related field required
Or equivalent combination of education and experience required
CPR or obtain CPR Certification
Possesses basic knowledge of optics including plus and minus lenses and their use with patients who are myopic, hyperopic, and have astigmatism
Understands the problems of presbyopia and how to correct for this and age values associated with this
Has intermediate ocular pharmacology knowledge of drops and medications used for eye examinations
Is able to identify the purpose of these commonly used medications including proper administration, dosage, durations, common side effects, and know hospital policy about shelf life of these medications
Knows common drugs used for ocular diseases such as glaucoma, infections, retina problems and steroid use
Has the understanding on how these medications work both within the eye and systemically

Job Responsibility

Performing state-of-the-art diagnostic testing for all Faculty, Fellows and Residents at the Flaum Eye Institute/Department of Ophthalmology
Performing technical testing, clinical support and patient care for various physician and sub-specialties throughout the eye institute
Providing intermediate to advanced diagnostic testing and imaging
Working closely with a Physician and spends most of the time working with patients and supporting the physicians
May perform as Lead Technician
Performing diagnostic testing or services in support of the following sub-specialties: cornea, comprehensive, glaucoma, neuro-ophthalmology, oculo-facial plastics, retina, and resident education
Performing advanced testing and imaging per provider's request
Assisting with coverage for: Ultrasound Biomicrography (UBM & B Scan), Fluorescein / ICG Angiography, Slitlamp & Gonio Biomicrography, Specular Biomicrography, Videography and Video editing, Retcam / Handheld Fundus Photography (Operating room imaging), HRT/Confocal Imaging
Performing clinical-clerical office duties, which would include checking diagnostic schedules, data entry, checking for request forms in advance, printing up results and related administrative activities deemed necessary by the department
Stocks rooms according to practice needs and adheres to hospital polices regarding locked items, sharps, checking medication for expired dates and opened dates

Fulltime

Intern, Clinical Pharmacology

BioMarin Pharmaceutical

Location:
United States

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 13, 2026

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