Associate Director/Director, Clinical Quality Assurance
Company: Mersana Therapeutics
Location: Cambridge
Posted on: May 12, 2022
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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:
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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