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:

Reporting to the Chief Scientific Officer, the Director of Clinical/Regulatory is responsible for overall management of the clinical drug development programs of DiaMedica and their regulatory processes.

This individual will provide management and leadership for the operational design, implementation and execution of clinical trials including day-to-day management of CROs, Project Managers, Clinical Supplies Management and Data Management. This position also directs, manages, and oversees regulatory activities in support of corporate objectives and develops and executes strategies for the earliest possible approvals.

PRIMARY RESPONSIBILITIES:

Clinical

  • Direct/Manage the organization's ongoing clinical research operations from initiation through delivery.
  • Work with clinical experts and management to design and execute clinical trials that generate compelling results and advance company goals
  • Responsible for CRO and vendor selection for individual trials as well as the development and implementation of metrics to ensure the quality and timeliness of deliverables.
  • Overall responsibility for the provision of data to be used in various reports.
  • Liaise with program management to ensure risks are proactively identified by clinical staff and mitigation solutions implemented as necessary.
  • Build and maintain relationships with vendors, sites, investigators, clinical advisors, and KOLs, as well as internal communication with both operational and business support groups.

Regulatory

  • Direct/Manage all regulatory submissions and communications to regulatory authorities. Ensure timely preparation of rigorous and compelling regulatory submissions. Evaluate need for external expertise for submission and together with project leads, manage and coordinate external input.
  • Develop integrated regulatory strategies for global filings, in collaboration with other departments, to expedite the conduct of trials and registration for each product.

QUALIFICATIONS:

Minimum Qualifications:

Technical Knowledge/Experience

  • University degree and 6 or more years of relevant leadership experience in pharma/biotech or CRO.
  • Strong leadership, project management, and negotiation skills are required.
  • Knowledge of advanced computer systems for Clinical Trial Management and Data Management.
  • Excellent written and verbal communication skills.

Preferred Qualifications:

  • Experience in biologics clinical development/ regulatory in the neurological/nephropathy space
  • Track record of positive FDA interaction
  • Advanced degree such as M.D., Ph.D. or M.Sc. is preferred
  • Post-graduate training in Regulatory Affairs is an asset

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 Vice President, Clinical and Regulatory Affairs is responsible for the strategy and execution of DiaMedica’s clinical drug development programs and their regulatory processes.

 This individual will provide effective leadership for the planning, design, implementation, and execution of clinical trials including management of CROs, Project Managers, Clinical Supplies Management, and Data Management. This position also will be responsible for the regulatory activities in support of corporate objectives and develops and executes strategies for quality systems, compliance, and interactions with regulatory authorities to achieve approvals for DiaMedica’s clinical programs and products. 

PRIMARY RESPONSIBILITIES:

Clinical

  • Build and lead the organization's ongoing clinical research operations from initiation through delivery.
  • Work with clinical experts and management to design and execute clinical trials that generate compelling results and advance company goals.
  • Communicate strategy and results to DiaMedica’s stakeholders, including senior management, the Board of Directors, shareholders and investors.
  • Responsible for CRO and vendor selection for individual trials as well as the development and implementation of metrics to ensure the quality and timeliness of deliverables.
  • Overall responsibility for the provision of data to be used in various reports.
  • Liaise with program management to ensure risks are proactively identified by clinical staff and mitigation solutions implemented as necessary.
  • Build and maintain relationships with vendors, sites, investigators, clinical advisors and KOLs as well as internal communication with both operational and business support groups.

Regulatory

  • Direct/Manage all regulatory submissions and communications to regulatory authorities. Ensure timely preparation of rigorous and compelling regulatory submissions. Evaluate need for external expertise for submission and together with project leads, manage and coordinate external input.
  • Develop integrated regulatory strategies for global filings, in collaboration with other departments, to expedite the conduct of trials and registration for each product.
  • Oversee the development and maintenance of DiaMedica’s quality systems and clinical standard operating procedures

General

  • Maintain and develop an effective network of clinical trial specialists to foster and extend DiaMedica’s clinical research programs
  • Build and manage DiaMedica’s internal clinical research team. Provide mentoring and career development for current staff, identify hiring needs, recruit and retain world class clinical talent.

QUALIFICATIONS:

Minimum Qualifications

Technical Knowledge/Experience

  • University degree and 8 or more years of clinical development and/or regulatory affairs experience in pharma/biotech/medtech.
  • Significant, documented experience as a successful line manager of a clinical development function in pharma/biotech/medtech
  • Strong leadership, project management, and negotiation skills are required.
  • Knowledge of advanced computer systems for Clinical Trial Management and Data Management.
  • Excellent written and verbal communication skills.

Preferred Qualifications

  • Experience in biologics clinical development/ regulatory in the neurological/nephropathy space
  • Track record of positive FDA interaction
  • Advanced degree such as M.D., Ph.D. or M.Sc. is preferred
  • Post-graduate training in Regulatory Affairs is an asset
  • A balanced ego. Patience, understanding, humility, and fortitude are a must.

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.