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Sr. Associate/Manager, Clinical Trial Supply

Frequency Therapeutics (Nasdaq: FREQ) is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The company’s lead product candidate, FX-322, is a potential disease modifying therapy designed to regenerate damaged auditory hair cells to improve hearing function. In a Phase 1/2 study of FX-322, the company observed clinically meaningful improvement in key measures of hearing function in patients with sensorineural hearing loss, the most common form of hearing loss. A Phase 2a study began in Q4 2019. The Frequency progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue and the company is researching an array of additional degenerative diseases where PCA may be applied, including a discovery program in multiple sclerosis.

The Senior Associate/Manager Clinical Trial Supply, reports to the VP, Pharmaceutical Development, and will have a leading role in ensuring Frequency’s clinical development program is executed effectively. The Sr. Associate/Manager’s expertise in clinical trial materials (CTM) supply, logistics, CTM packaging, and clinical site supply will play a key role in achieving the company’s clinical objectives. This role is a key intersection between clinical operations, pharmaceutical development, regulatory affairs, and quality assurance.

Key Responsibilities Include:

  • Define and advise the Clinical Operations team on the optimal clinical trial supply strategy in terms of, but not limited to, packaging design, technical and timeline feasibility, efficiency and risk management
  • Review overall clinical trial protocol/protocol amendments, provide inputs to develop optimal packaging design, clinical trial supply design and visit schedule
  • Create and maintain complete and accurate clinical supply demand for assigned study in alignment with protocol requirements, key study parameters and milestones, patient projections, with appropriate overage and by using defined processes and systems
  • Create and drive finalization of the packaging design and a comprehensive label strategy for all participating countries in the clinical trial
  • Define clinical supply parameters for IRT set up and initiates subsequent updates throughout the duration of the clinical trial
  • Develop and execute a trial-level project plan together with all other relevant roles.
  • Identify, assess and proactively communicate supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity
  • Coordinate the manufacture, packaging, labeling, and kitting with external development partners
  • Ensure CTM complies with regulatory and quality requirements
  • Additional responsibilities as assigned

Qualifications:

  • A Bachelor’s degree from a four-year college or university in health, biology, chemistry, physiology, or a related field
  • 3 – 5 years’ experience related to clinical trial materials, packaging, labeling, and clinical site distribution
  • Demonstrated knowledge of the drug development process and good manufacturing practices
  • Thorough understanding of quality and regulatory requirements for clinical materials including relevant FDA and ICH guidance documents
  • Proven project management, organizational and planning skills, and the ability to problem solve and exercise creativity
  • Exceptional communication skills as well as the ability to present confidently for internal and external audiences
  • Ability to travel up to 20% of the time

Corporate Culture:

A fundamental belief held by the Frequency Therapeutics team is that we have the best chance to achieve our mission by bringing together our collective problem-solving and leadership skills into a single, collaborative front. We look for people who envelop competence and self-awareness, retain the courage to state thoughts, wants and needs, and have the ability to make good judgment calls and decisions. We want people who are undeterred by uncertainty, convert adversity into opportunity, and turn understanding into action while driving motivation for the team at large.

We offer a competitive compensation and benefit package with opportunities to participate in groundbreaking technology.

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Sr. Associate/Manager, Clinical Trial Supply

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