Attralus is a biotechnology company with novel protein therapeutics and diagnostics directed at systemic amyloidosis, which is responsible for a wide range of disease states that are currently underserved by currently available drugs and diagnostics. To meet our strategy of rapidly advancing our novel products, especially our lead diagnostic which is entering late-stage clinical studies and is preparing for commercialization, the Company seeks the services of a radiopharmaceuticals expert to support the CMC function. Reporting to the Senior Vice President of CMC, the Senior Director, Radiodiagnostics Development and Commercialization will work both independently and with cross-functional teams to provide timely, high-quality support of our lead radiodiagnostic, along with early-stage development of other pipeline radiodiagnostics. The position will function remotely, with occasional travel to contract manufacturing facilities as needed.

 

ROLES, RESPONSIBILITIES & EXPECTATIONS

  • Lead the CMC strategic development and execution for the company’s radiodiagnostics products, through their respective stages of clinical development.
  • Lead and manage the commercial CMO strategy, supply planning, distribution and commercial expansion
  • Lead the oversight of all GMP contract service providers for the company’s radiodiagnostics, including evaluation of additional CMO’s as appropriate to support marketing approval and post-launch expansion
  • Collaborate with current Attralus staff and consultants, which include experts in the CMC and GMP Quality activities associated with the unlabeled ligand, and with the current radioisotope and drug product manufacturers
  • Work directly with CMC Project Management and Portfolio Management to establish timelines, objectives, deliverables and budgets, including assessment of progress and risks
  • Work directly with Product Team and Commercial Leads on commercial launch strategies
  • Work directly with CMC Quality to establish aspects of the Attralus Quality Management System which ensure GMP compliance according to industry and regulatory expectations for radiodiagnostics
  • Serve as Attralus CMC’s lead technical expert on cross-functional radiodiagnostics teams, including interactions with external collaborators, potential partners and regulatory authorities
  • Serve as the scientific and technical lead for regulatory filings and direct interactions with regulatory authorities for the company’s radiodiagnostics, with focus on late-stage and commercial communications

 

REQUIREMENTS/QUALIFICATIONS

  • A Bachelor’s degree with a minimum of 10 years of experience with radiopharmaceuticals or radiodiagnostics, and a minimum of 7 years in scientific/technical management
  • Experience with clinical development of radiopharmaceuticals or radiodiagnostics is essential (preference will be given to candidates with experience in the commercialization of such products)
  • In-depth knowledge of radiopharmaceutical or radiodiagnostics GMP drug development is essential
  • Selection and oversight of contract development and manufacturing of radiopharmaceuticals or radiodiagnostics, including radioisotope production and distribution, is essential
  • Outstanding organizational, interpersonal, written and oral communication skills are critical, both within and outside of the company
  • Highly Desired:
    • Experience with commercial supply planning for radiopharmaceuticals or radiodiagnostics
    • In-depth knowledge of clinical administration of radiopharmaceuticals or radiodiagnostics
    • Experience in the authorship of CMC regulatory filings
  • Experience working in a fast-paced, startup/small company corporate environment is a significant advantage.