Careers

At DiaMedica Therapeutics, we seek talented contributors who thrive in a high-energy team environment and want to make a real and lasting impact in the field of therapeutics. DiaMedica Therapeutics teams are creative, collaborative, open, committed–and central to the success of this company and its mission. If this is the kind of company you want to work for, we want to hear from you.

Send us your resume.

Please, no unsolicited resumes from recruiters.

Openings

POSITION DESCRIPTION:

The Director, Regulatory Affairs is responsible for overall management of the Regulatory Affairs function supporting DiaMedica Therapeutics’ drug development programs. This position directs, manages, and oversees regulatory activities in support of corporate objectives and develops and executes strategies for timely approval of high-quality development programs and marketed products.

PRIMARY RESPONSIBILITIES:

  • Ensure timely preparation, submission, liaison, and tracking of rigorous and compelling regulatory submissions, including Investigational New Drug Applications (IND) and New Drug Applications (NDA) and related correspondence.
  • Act as the primary company contact for regulatory agencies.
  • Prepare for and participate in meetings with regulatory agencies such as Food and Drug Administration (FDA) Pre-IND and Pre-NDA meetings.
  • Maintain all regulatory files, ensuring documentation is complete, up to date, and audit ready.
  • Prepare for and participate in internal and regulatory agency audits.
  • Work closely with cross-functional teams, including CMC, pre-clinical, clinical, and quality, to ensure coordination of timelines and deliverables and confirm study designs meet regulatory requirements.
  • Monitor and communicate changes in the regulatory landscape, provide expertise on requirements for current programs and products, and participate in the development of regulatory strategies to achieve company objectives.
  • Identify issues that may increase regulatory and corporate risk and propose informed strategies to address such risks.
  • Evaluate need for external expertise for submissions and manage and coordinate external input.
  • May develop and provide work direction to regulatory department personnel through direct line management.
  • Participate in organizational initiatives related to SOP development, training, or other projects.

QUALIFICATIONS:

Minimum Qualifications

  • Bachelor degree
  • 8+ years leadership experience in pharmaceutical or biopharmaceutical Regulatory Affairs
  • Demonstrated working knowledge of the drug development process and US regulatory guidelines and regulations specific to INDs and NDAs
  • Experience interfacing directly with regulatory authorities
  • Strong leadership, organizational, negotiation, and problem-solving skills
  • Excellent written and verbal communication skills and analytical skills, with high attention to detail and quality

Preferred Qualifications

  • Experience in working with clinical development of protein biologics
  • Experience with therapeutics that treat neurological and/or kidney diseases
  • Track record of positive FDA interaction
  • Experience with regulatory processes in the EU, Asia, or Australia
  • Post-graduate degree in Regulatory Affairs and/or Regulatory Affairs Certification (RAC)
  • Experience in electronic submission template (eCTD format)

LOCATION: Plymouth, Minnesota

ABOUT DIAMEDICA THERAPEUTICS:

DiaMedica Therapeutics is a biopharmaceutical company focused on the discovery and development of novel therapeutic compounds that target deficits in microvascular circulation such as ischemic stroke and diabetic nephrology. DiaMedica's lead compound, DM199, is a clinical stage recombinant human protein that represents a novel biological approach to improving brain and kidney function and moving into phase II studies.

We are an equal opportunity employer. It is our policy to provide equal employment opportunities to all qualified persons without regard to race, color, creed, sex, religion, national origin, age, marital status, disability, sexual orientation, protected veteran status, or status with regard to public assistance, local human rights commission activity, genetic information, or any other protected category and to comply with applicable federal, state, and local regulations regarding discrimination in employment.

Send cover letter and resume to HR@diamedica.com.

POSITION DESCRIPTION:

The Quality Assurance Manager is responsible for overall management of quality processes. This position provides Good Manufacturing/Laboratory/Clinical Practice (GxP) and compliance related advice across business functions as they relate to DiaMedica Therapeutics’ drug development programs. The incumbent will have primary responsibility for the creation and maintenance of a Quality Management System, including initiation of Standard Operating Procedures (SOPs), document control oversight, and coordination of audits for compliance with GxP, protocols, instructional documents, regulations, and other applicable standards.

PRIMARY RESPONSIBILITIES:

  • Develop and maintain the DiaMedica Quality Management System, including creation and continued assessment of SOPs
  • Create and maintain document change control procedures to ensure that essential documentation is complete, up to date, and audit ready
  • Establish and manage a corporate training plan to ensure training is executed and documented on internal procedures for all DiaMedica personnel
  • Participate in vendor selection activities across all DiaMedica functions
  • Lead the creation, execution, and maintenance of audit plans that support the compliance of DiaMedica internal functions, vendors, and clinical research sites
  • Develop Corrective/Preventative Action Plans or process improvement initiatives when compliance issues are identified internally, or at vendors or clinical research sites
  • Participate in regulatory agency inspections of DiaMedica, and support vendor or clinical research sites during inspections as they relate to DiaMedica projects
  • Offer formal compliance opinions, providing interpretation of SOPs, regulations, and regulatory authority guidance
  • Remain current in regulatory requirements and industry standards for GxP

QUALIFICATIONS:

Minimum Qualifications

  • Bachelor degree
  • 3+ years of experience in quality assurance and/or regulatory compliance activities in a Food and Drug Administration (FDA) regulated pharmaceutical, medical device, or biotechnology organization
  • Good understanding of document control/management in a GxP regulated environment
  • Keen understanding of the key requirements for compliance to FDA regulations/guidance and GxP
  • Technical ability to critically analyze and synthesize compliance-related information and present the associated risks
  • Experience in audit plan creation and execution of compliance audits
  • Highly developed investigational skills

Preferred Qualifications

  • Pharma/biotech experience
  • Experience in hosting or supporting regulatory inspections
  • Experience auditing Phase 1-3 clinical trials

LOCATION: Plymouth, Minnesota (This is not a remote-based position.)

ABOUT DIAMEDICA THERAPEUTICS:

DiaMedica Therapeutics is a biopharmaceutical company focused on the discovery and development of novel therapeutic compounds that target deficits in microvascular circulation such as ischemic stroke and diabetic nephrology. DiaMedica's lead compound, DM199, is a clinical stage recombinant human protein that represents a novel biological approach to improving brain and kidney function and moving into phase II studies.

We are an equal opportunity employer. It is our policy to provide equal employment opportunities to all qualified persons without regard to race, color, creed, sex, religion, national origin, age, marital status, disability, sexual orientation, protected veteran status, or status with regard to public assistance, local human rights commission activity, genetic information, or any other protected category and to comply with applicable federal, state, and local regulations regarding discrimination in employment.

Send cover letter and resume to HR@diamedica.com.

POSITION DESCRIPTION:

 Reporting to the Director of Clinical and Regulatory, the Regulatory & Clinical Trial Specialist executes the regulatory strategy in support of DiaMedica Therapeutics company objectives. Secondary to the regulatory function, this position may also support the planning and execution of clinical trials. 

PRIMARY RESPONSIBILITIES:

Regulatory

  • Prepare, coordinate, and maintain global regulatory submissions, including Investigational New Drug Applications (IND) and New Drug Applications (NDA) to ensure timely approvals for clinical studies and market release
  • Assist in the development of regulatory strategies to achieve company objectives
  • Act as the primary company contact for regulatory agencies
  • Prepare for and participate in meetings with regulatory agencies such as Food and Drug Administration (FDA) Pre-IND and Pre-NDA meetings
  • Ensure that pre-clinical and clinical study designs meet regulatory requirements
  • Maintain all regulatory files, ensuring documentation is complete, up to date, and audit ready
  • Prepare for and participate in internal and regulatory agency audits
  • Select and manage external vendors/consultants to ensure that deliverables are completed on time, within budget, and are consistent with the scope of work
  • Monitor global regulatory changes and distribute information to key stakeholders
  • Participate in departmental initiatives related to SOP development, training, or other projects
  • Develop an understanding of competitive landscapes for assigned products and therapeutic areas

Clinical

  • Assist with the development of study related documents and materials such as protocols, study plans, informed consents, and recruitment materials
  • Perform quality review of study documentation to ensure audit-readiness
  • Support the development of clinical study reports
  • Assist in the planning of investigator and coordinator meetings, Safety Review Committee meetings, or other meetings as required, including preparation of meeting materials
  • Assist with vendor management

QUALIFICATIONS:

Minimum Qualifications

  • BA/BS degree
  • 2+ years of regulatory experience in a biopharmaceutical or medical device company
  • Working knowledge of FDA regulations related to investigational drug/device applications and marketing approval
  • Excellent interpersonal and communication skills (oral and written) with the ability to work independently and in a team environment
  • Demonstrates good judgement and seeks the advice of others when necessary
  • Strong analytical skills with high attention to detail and accuracy
  • Strong organizational skills with the ability to problem-solve and manage multiple tasks

Preferred Qualifications

  • Pharma/biotech experience
  • IND/NDA experience
  • RAPS Professional Certification (RAC)
  • Working knowledge of Good Clinical Practices (GCP) and current industry practices related to the conduct of clinical trials

LOCATION: Plymouth, Minnesota

ABOUT DIAMEDICA THERAPEUTICS:

DiaMedica Therapeutics is a biopharmaceutical company focused on the discovery and development of novel therapeutic compounds that target deficits in microvascular circulation such as ischemic stroke and diabetic nephrology. DiaMedica's lead compound, DM199, is a clinical stage recombinant human protein that represents a novel biological approach to improving brain and kidney function and moving into phase II studies.

We are an equal opportunity employer. It is our policy to provide equal employment opportunities to all qualified persons without regard to race, color, creed, sex, religion, national origin, age, marital status, disability, sexual orientation, protected veteran status, or status with regard to public assistance, local human rights commission activity, genetic information, or any other protected category and to comply with applicable federal, state, and local regulations regarding discrimination in employment.

Send cover letter and resume to HR@diamedica.com.