Medical Director (MD or DO. Board Certified), Medical Affairs

 

About Aquinox:

Aquinox Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology. Our primary focus is anti-inflammatory product candidates targeting SH2-containing inositol-5'-phosphatase 1, or SHIP1, which is a key regulator of an important cellular signaling pathway in immune cells, known as the PI3K pathway. Aquinox's lead drug candidate, rosiptor (AQX-1125), is a small molecule activator of SHIP1 suitable for oral, once daily dosing.  In September, 2016, we began enrolling patients in a Phase 3 clinical trial in our lead indication, Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).  Other indications are under consideration for future investigation. Aquinox has a broad intellectual property portfolio and pipeline of preclinical drug candidates that activate SHIP1. For more information, please visit www.aqxpharma.com.

Aquinox is publicly traded on NASDAQ (AQXP) with offices in Vancouver, BC, Canada and in San Bruno, CA, USA.

 

The Opportunity:

The Medical Director is accountable for clinical/medical input into and oversight of assigned products across the product lifecycle including active participation in or leading protocol design, strategy, clinical execution; review and analysis of safety and efficacy data from all sources, development of risk management plans and assessment of benefit risk profile of the product. This position is responsible for performing activities in accordance with FDA regulations, ICH guidelines and applicable SOPs in collaboration with the other departments to ensure successful trial completion, oversight of patient safety which may include direct medical monitoring and pharmacovigilance oversight, and effective management and communication of the benefit/risk profile of the product.

Reporting to the Chief Medical Officer and Vice President, Clinical Development and Regulatory Affairs, the Medical Director will work collaboratively across functional areas including Clinical Operations, Clinical Development, Drug Safety, Regulatory Affairs, Medical Affairs, and Biostatistics/Data Management and others.

This position will be located in our San Bruno, CA, USA office.

 

The Medical Director will:

  • Lead Medical/Safety Team for assigned products in the evaluation, communication and management of safety signals for all clinical trials (e.g. safety data review, safety committee participation, signal detection review for DSUR, etc.)
  • Oversee safety aspects for clinical studies and working with clinical counterparts as needed to ensure appropriate study conduct from a medical safety perspective.
  • Provide medical assessment of individual case safety reports (ICSRs) including causality assessment, determination of expectedness, identification of events of interest
  • Author relevant sections and conclusions of product safety profile for aggregate reports
  • Manage external pharmacovigilance consultants and CROs, providing them with strategic leadership and oversight of safety monitoring
  • Participate in or lead the development of clinical trial protocols, trial documents, study reports
  • Participate in the medical/clinical preparation and review of applicable clinical study plans (ie. safety monitoring plans, adjudication plan, investigator brochures, statistical analysis plans)
  • Participate in the review, analysis, and interpretation of clinical study data
  • Develop medical/clinical content for regulatory submissions (e.g. pre-IND meeting materials, IND and/or NDA submission packages, draft package insert labeling, or regulatory response documents, etc.)
  • Contribute to medical/clinical interactions with regulatory authorities
  • Work collaboratively with other internal and external clinical staff in development strategy, trial execution and oversight (e.g., biostatisticians, data managers, clinical operations, medical writing, etc.)
  • Interact with external medical experts as related to study development and therapeutic areas
  • Work collaboratively with Medical Affairs on the interpretation and reporting of data for publication and presentation, and participate in cross-functional teams to provide medical/clinician perspective
  • Manage, mentor, and/or professionally develop assigned clinical team members as appropriate
  • Attend conferences and remain current with relevant therapeutic area information
  • Other duties as assigned

 

Required Experience:

  • MD or DO. Board Certified/Board Eligible or equivalent with a 7+ years’ experience in the pharmaceutical industry (combined across development and/or drug safety) – therapeutic area experience in inflammation, urology or ophthalmology desired
  • Track record of successfully participating in or leading the execution of Phase 1-3 clinical trials from concept to completion
  • Broad, in-depth understanding of all aspects of drug development including: clinical trial design, execution, safety management, biostatistics/data management, US and international regulatory and quality standards, and pharmacovigilance requirements
  • Expertise in global pharmacovigilance and clinical safety regulations and guidelines
  • Ability to objectively interpret, analyze and communicate medical and scientific data
  • Capability to rapidly be familiar with various therapeutic areas
  • Experience with MedDRA and drug safety databases, such as ARISg
  • Strong communication skills both written and verbal
  • Understanding and knowledge of Good Clinical Practice and ICH guidelines
  • Ability to develop and maintain collaborative relationships (internally and externally)
  • Ability to travel as required, including limited international travel (average 15-25% total travel)

 

Our current clinical trials, exceptional team, and strong track record make it an excellent time to seize this exciting opportunity! We provide a collaborative and innovative environment with competitive incentive packages and rewards.

Interested candidates are invited to forward their resume and cover letter to careers@aqxpharma.com, indicating why you feel you are a fit for the Medical Director role at Aquinox Pharmaceuticals, Inc.

We thank all applicants for their interest; only those chosen for an interview will be contacted.