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Associate Director/Director, Clinical Quality Assurance

Company: Mersana Therapeutics
Location: Cambridge
Posted on: May 12, 2022

Job Description:

Associate Director/Director, Clinical Quality Assurance Mersana -Therapeutics, Inc. -(Nasdaq: MRSN) is a clinical-stage biopharmaceutical company using its differentiated and proprietary antibody-drug conjugate (ADC) platforms to develop highly targeted drugs with increased tolerability and expanded opportunities to deliver meaningful clinical benefit to patients. -Mersana's lead product candidate, upifitamab rilsodotin (UpRi), is a Dolaflexin ADC targeting NaPi2b and is being studied in UPLIFT, a single-arm registration strategy in patients with platinum-resistant ovarian cancer, as well as in the expansion portion of a Phase 1 proof-of-concept clinical study in patients with NSCLC adenocarcinoma. XMT-1592, Mersana's second ADC product candidate targeting NaPi2b-expressing tumors, was created using Mersana's customizable and homogeneous Dolasynthen platform and is in the dose escalation portion of a Phase 1 proof-of-concept clinical study. The Company's early-stage programs include XMT-1660, a Dolasynthen ADC targeting B7-H4, as well as XMT-2056, a STING-agonist ADC developed using the Company's Immunosynthen platform. -In addition, multiple partners are using -Mersana's -Dolaflexin platform to advance their ADC pipelines. Mersana's -mission is to discover and develop life-changing antibody-drug conjugates for patients fighting cancer. We seek individuals who share our excitement about the possibilities our proprietary drug conjugation platforms offer, as well as our commitment to making a meaningful difference for patients and their families. At -Mersana -we have a highly collaborative culture and believe that our collective ability to make a difference exceeds the sum of our individual efforts. -

What's in it for you?

In this role, you will have an opportunity to shape the growth of a Clinical Quality function. You will form close partnerships with key clinical and medical stakeholders as well as the overall Quality Assurance organization. This is an impactful role where you will ensure successful and compliant execution of our clinical programs. To be successful, you will have previous experience ensuring GCP compliance for clinical programs leading to a successful BIMO inspection and subsequent approval. The Associate Director/Director of Clinical Quality Assurance will be responsible for representing the Clinical Quality organization both internally (e.g., clinical subteams) and externally (e.g., CRO's) via direct involvement as well as through the direction of others, including contractors and vendors. The successful candidate will form critical collaborative partnerships with the rest of the Quality Organization as needed. This role will ultimately report to the VP of Clinical Quality Assurance within the Regulatory Affairs & Quality Assurance organization. How do you know if you're the right fit?

You will possess experience in:

  • Acting as the SME at clinical subteams for investigator and vendor auditing.
  • Leading deviation identification including CAPA development.
  • Evaluation, authoring, and revision to critical procedures, including SOPs, work instructions, and associated documents.
  • Contribution to readiness activities to support potential regulatory agency inspections.
  • Working closely with the Quality organization and within the matrix team environment to provide expert compliance information, manage identified issues, and support continuous improvement for programs.
    The other stuff
    This position is best suited for Bachelor or Masters' degree candidates in a scientific or life sciences discipline. A minimum of 8-10 years of relevant experience with increasing responsibilities in the Biotech/ Pharmaceutical Industry, specifically within GCP, clinical monitoring or equivalent and with at least 5 years in clinical quality or clinical compliance. A track record of success working closely with clinical teams to ensure compliant clinical programs and successful inspections. Position is eligible for bonus, option awards and benefits including medical, dental and life insurance, 401(k) participation, vacation, and paid holidays. Successful candidate must be authorized to work in the United States. Mersana Therapeutics, Inc. is an equal opportunity employer.

Keywords: Mersana Therapeutics, Cambridge , Associate Director/Director, Clinical Quality Assurance, Executive , Cambridge, Massachusetts

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