Current Vacancies

Current Vacancies:


Clinical Pharmacologist/Senior Clinical Pharmacologist

Full-time position
Competitive salary plus benefits
Based in Minneapolis, MN

Proximagen is a drug discovery and development company currently focused on research and development in the areas of CNS, pain, and inflammation.  Translational medicine and development activities are conducted out of the Minneapolis, MN site. We have a vibrant pipeline which includes a diverse range of projects spanning from early discovery through to Phase II clinical trials.

Reporting to the Director of Clinical Pharmacology, the Clinical Pharmacologist will provide clinical pharmacology support for preclinical and early clinical phase programs with an emphasis on effective transition into clinical development.  This position will contribute to clinical development planning for various indications of interest including achieving rapid proof-of-concept (POC).   The candidate should have an excellent knowledge of Clinical Pharmacology and DMPK principles, such as PK, PK/PD, drug metabolism.  PBPK modeling experiences is preferred.  Level of position commensurate with prior experience.

Responsibilities

  • Contribute to development of Clinical Development Plans for compound candidates with an emphasis on clinical pharmacology and early phase development (i.e. to POC) with supervision
  • Assists in pharmacokinetic analysis, interpretation, and reporting of data from studies.
  • Supports design and analysis of toxicokinetic studies
  • Evaluate and interpret PK/PD data and associated analyses
  • PBPK modeling to predict human PK, dose, and drug-drug interaction potential.
  • Contribute to the development of clinical study concepts, study protocols, study reports for early phase compounds with supervision
  • Provides input to Investigator’s Brochure and Clinical Pharmacology sections of INDs and CTAs with supervision
  • Conducts literature searches and prepare summary documents related to therapeutic areas, study designs, biomarkers, and other Clinical Pharmacology and Translational Medicine evaluations
  • Effectively communicate (oral and/or written) project-related information to Clinical Pharmacology management

Preferred Qualifications and Competencies

  • PhD, PharmD or MD
  • 2+ years of relevant experience
  • Strong understanding of clinical pharmacokinetic concepts including PK, PK/PD, drug metabolism, and translational medicine
  • Knowledge and/or hands on experience interpreting dose-response and PK/PD data to inform clinical study designs and drug development decision-making
  • Understanding of drug development process to provide clinical pharmacology support for preclinical and clinical programs
  • Working knowledge of common tool(s) for quantitative clinical pharmacology such as NONMEM, WinNonlin, R, Gastroplus, Simcyp
  • Knowledge of regulatory guidance’s related to clinical pharmacology
  • Ability to quickly learn the mechanism, endpoints, treatments and studies designs for relevant diseases
  • Exhibit excellent written and verbal data presentation skills to enable contribution to internal/external teams
  • Ability to effectively collaborate on teams while taking personal accountability for timely completion of deliverables
  • Strong analytical mindset and problem-solving skills
  • Ability to effectively multi-task and deliver results on time

Mental/Motor Requirements

  • Constant reading, writing, problem solving, attentiveness and tact
  • Frequent verbal and written communication, independent decision making and reasoning

Environmental Requirements

  • Frequently works with others and alone in a general office environment

Physical Requirements

  • Constant sitting (80%) and near vision activities. Frequent fingering such as keyboard use, handling, talking and hearing. Occasional standing and moving about (20%) and reaching. Occasionally lifts and carries up to 20 pounds

Other

  • Travel: Up to 10% travel within the continental United States and Globally as required
  • Strong interpersonal, organizational and proofreading skills
  • Ability to perform detail orientated work
  • Understanding of FDA regulations, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

How to apply
If you would like to be considered for this role, please apply to pvaness@proximagen.com outlining your suitability for this role and providing your CV. Please use ‘Clinical Pharmacologist/Senior Clinical Pharmacologist’ in the subject box of your email.


Director, Clinical Pharmacology

Full-time position
Competitive salary plus benefits
Based in Minneapolis, MN

Proximagen is a drug discovery and development company currently focused on research and development in the areas of CNS, pain, and inflammation.  Translational medicine and development activities are conducted out of the Minneapolis, MN site. We have a vibrant pipeline which includes a diverse range of projects spanning from early discovery through to Phase II clinical trials.

Reporting to the Chief Development Officer, the Director of Clinical Pharmacology will oversee and provide clinical pharmacology support for preclinical and early clinical phase programs with an emphasis on effective transition into clinical development.  This position will interact closely with senior management and contribute to clinical development planning for various indications of interest including achieving rapid proof-of-concept (POC).   The candidate should have an excellent knowledge of Clinical Pharmacology and DMPK principles, such as PK, PK/PD, drug metabolism, thorough understanding of regulatory guidelines with experience in regulatory filings (IND, NDA, CTA, etc.) and demonstrated strong leadership skills and ability to mentor junior staff.

Responsibilities

  • Oversees or conducts the design, conduct, analysis and interpretation of clinical pharmacology, including management of resources and activities
  • Interacts closely with and provides clinical pharmacology expertise to senior management decision making
  • Provides scientific and technical support on clinical pharmacology related issues within and across programs
  • Supports other clinical studies including First-in-Human, Proof-of-Concept or registration studies
  • Accountable for all pharmacometric modeling and simulation activities (PK, population PK, PK/PD, PBPK and clinical trial simulations) including clinical interpretation of results and/or providing oversight to contract organizations conducting these activities
  • Provides recommendation on the starting dose in the first clinical trial based on allometric scaling or physiologically based PK modeling
  • Responsible for preparation of the clinical pharmacology sections (PK, biomarkers, Bioanalytical) of early clinical protocols
  • Provides key guidance and input (and/or drafts documents) on clinical study protocols and study reports, IB’s, annual safety reports, regulatory submissions and other documents as needed for clinical pharmacology needs
  • Provides clinical pharmacology scientific input on licensing opportunities as part of due diligence activities
  • Represents Clinical Pharmacology on cross-functional development teams providing pharmacology and pharmacometric support for ongoing development activities
  • May supervise Clin Pharm staff (scientists) and/or managed outsourced resources
  • In conjunction with Statistics, responsible for completing Statistical Analysis Plans for clinical pharmacology studies
  • Responsible for Clinical Pharmacology interactions with Regulatory Health Authorities

Preferred Qualifications and Competencies

  • PhD, PharmD or MD
  • 8+ years of relevant experience
  • Strong understanding of clinical pharmacokinetic concepts including PK, PK/PD, drug metabolism, and translational medicine
  • Knowledge and/or hands on experience interpreting dose-response and PK/PD data to inform clinical study designs and drug development decision-making
  • Understanding of drug development process to provide clinical pharmacology support for preclinical and clinical programs
  • Working knowledge of common tool(s) for quantitative clinical pharmacology such as NONMEM, WinNonlin, R, Gastroplus, Simcyp
  • Knowledge of regulatory guidance’s related to clinical pharmacology
  • Ability to quickly learn the mechanism, endpoints, treatments and studies designs for relevant diseases
  • Exhibit excellent written and verbal data presentation skills to enable contribution to internal/external teams
  • Ability to effectively collaborate on teams while taking personal accountability for timely completion of deliverables
  • Strong analytical mindset and problem-solving skills
  • Ability to effectively multi-task and deliver results on time
  • Strong leadership skills including the ability to mentor junior staff

Mental/Motor Requirements

  • Constant reading, writing, problem solving, attentiveness and tact
  • Frequent verbal and written communication, independent decision making and reasoning

Environmental Requirements

  • Frequently works with others and alone in a general office environment

Physical Requirements

  • Constant sitting (80%) and near vision activities. Frequent keyboard use, handling, talking and hearing. Occasional standing and moving about (20%) and reaching. Occasionally lifts and carries up to 20 pounds

Other

  • Travel: Up to 10% travel within the continental United States and Globally as required
  • Strong interpersonal, organizational and proofreading skills
  • Ability to perform detail orientated work
  • Understanding of FDA regulations, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

How to apply
If you would like to be considered for this role, please apply to pvaness@proximagen.com outlining your suitability for this role and providing your CV. Please use ‘Director Clinical Pharmacology in the subject box of your email.