Associate Director, Clinical Quality Assurance at Acceleron Pharma
Cambridge, MA, US
Acceleron is a Cambridge-based, clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company's leadership in the understanding of TGF-beta biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair.

Acceleron focuses its research and development efforts in hematologic, neuromuscular, and pulmonary diseases. In hematology, the Company and its global collaboration partner, Celgene, are developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. Acceleron is also advancing its neuromuscular franchise with two distinct Myostatin+ agents, ACE-083 and ACE-2494, and a Phase 2 pulmonary program with sotatercept in pulmonary arterial hypertension.

What’s in it for you?

The Associate Director of Clinical Quality Assurance (QA) will be responsible for providing QA support of clinical programs at Acceleron. This individual will be the subject matter expert in Good Clinical Practice (GCP), develop standards and partner with Clinical Operations, Regulatory, Biostatistics, Safety, Medical Research, Non-Clinical Development, and other functions to establish and document risk-based GCP processes and procedures. The AD of Clinical QA will ensure compliance with applicable regulations with regards to sponsor oversight of Acceleron’s clinical programs.

What will you be doing? 
  • Support investigational new drug applications, ex-US clinical trial applications (CTA), and related correspondence from global regulatory authorities
  • Deploy Acceleron’s GCP oversight, compliance and inspection readiness system to Clinical Study Teams (CST) to ensure quality product during clinical trials and compliance with ICH guidelines and applicable global health authority regulations
  • Verify clinical trials data to ensure trials are conducted in accordance with applicable study protocols, and in compliance with GCP and ICH guidelines
  • Partner with Supply Chain, Clinical Research, Product Development departments and CMOs/CROs to identify and implement GxP procedures in compliance with regulations/guidelines
  • Escalates GCP Quality events as appropriate
  • Provides QA and QC review of clinical and regulatory documents
  • Manage clinical investigations and risk assessments as needed
  • Manage process audits of CROs and other clinical support vendors
  • Provide QA support for CRO Oversight
  • Provide QA support for Critical Quality Issues and Protocol Deviations
  • Be the primary point of contact between quality assurance and clinical operations for clinical study teams (CST)
  • Provide interpretation and guidance for internal and external customers on clinical quality related regulations/guidelines (FDA, ICH, EU, etc.) and company procedures and policies, proactively maintaining cognizance of current GCP standards
  • Coordinate, develop, maintain and/or provide GCP training to personnel
  • Participate in company preparations for regulatory inspections
  • Partner with Clinical Operations and Regulatory to establish a library of relevant clinical and regulatory document templates as appropriate
  • Create or improve processes to ensure compliance with GCP regulations
  • Review/revise/author standard operating procedures (SOPs) as needed
 What are we looking for?
  • Acceleron is seeking candidates who are self-motivated and directed; who operate with the highest integrity, embrace an atmosphere of continuous improvement, and share our commitment to data-driven decision making. This candidate must have excellent knowledge of EU and FDA regulatory landscape and trends and be able to proactively communicate this knowledge to internal/external stakeholders
  • Bachelor’s degree in a scientific discipline is required. An advanced degree is preferred
  • Minimum of 10-12 years of relevant experience in a biotech/pharmaceutical setting with at least 6 years of GCP Quality Assurance experience
  • Experience authoring and implementing GCP procedures
  • Strong working knowledge of GCP for drug/device covering all phases of clinical study program (Phase I to IV)
  • Broad understanding of international regulations and guidance documents
  • Conducted GxP audits and actively participated in regulatory inspections
  • Proactive in identifying opportunities along with strong problem solving and negotiation skills. Hands-on execution of all aspects of quality assurance functions in support of GxP activities in an entrepreneurial, fast-paced environment
  • Well-prepared, competent, and confident when interacting with senior management, regulatory authorities, and internal and external partners
  • Ability to remain objective/autonomous in implementing the Quality Program, while at the same time taking ownership and proactively working with the rest of the team to achieve the desired quality objectives
  • Strong experience in IND and CTA filings; NDA/BLA/MAA experience strongly preferred
How will you grow with us?

This candidate will advance Acceleron’s innovative pipeline through proactively developing and influencing quality specific standards. As the pipeline progresses, this candidate will increase their strategic planning skills to align pipeline progression to the regulatory climate and global footprint.

 

*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.