Senior Manager Biosample Operations
Senior Manager Biosample Operations
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The Organization
Whats happening at Entrada Therapeutics Entrada is a clinicalstage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.
Our Endosomal Escape Vehicle (EEV)therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues resulting in an improved therapeutic index. Through this proprietary versatile and modular approach Entrada is advancing a robust development portfolio of RNA antibody and enzymebased programs for the potential treatment of neuromuscular ocular metabolic and immunological diseases among others.
Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44 45 50 and 51 skipping amenable. Entrada has partnered to develop a clinicalstage program VX670 for myotonic dystrophy type 1.
We are a tightknit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a highenergy dedicated team that likes to get things done and dramatically improve the lives of patients and their families.
The Perfect Addition to Our Team
You are excited about the opportunity to spearhead and support the expansion of our clinical operations function here at Entrada within Biosample Operations. You are well organized and like to share best practices in clinical operations clinical supply and logistics. You enjoy a fastpaced environment and juggling competing priorities and are willing to jump in and help wherever it is needed. You follow up and follow through efficiently connecting problems with solutions. You work successfully in a team environment and have strong interpersonal skills in order to effectively build working relationships inside and outside of the company.
The Opportunity
The Senior Manager Biosample Operations willbe responsible for planning implementing and managing biological sample logistics across Phase IIV Clinical Trials. This role is an essential member of the Clinical Operations function and must be able to collaborate with the crossfunctional teams both internally and externally to achieve project milestones and clinical study timelines in alignment with company goals.
Responsibilities
- Advise on and deliver the sample strategy for clinical trials within the requirements of quality and ethical and regulatory standards including ICH/GCP/GLP.
- Oversee operational activities required to manage the lifecycle of clinical trial samples including but is not limited to oversight of sample collection at sites shipment to vendor for processing/testing managing sample queries and final sample disposition.
- Implement and execute sample collection processing storage and reconciliation with the goal of maximizing sample accrual and quality.
- Independently review clinical study protocols informed consents laboratory documents case report forms laboratory scopes of work laboratory budgets and invoices.
- Manage necessary vendor laboratory documents for the Trial Master File (TMF) as applicable.
- Act as the primary point of contact for study team related to sample operations for assigned clinical trials.
- Collaboratewithcrossfunctionalstudyteamsto ensure delivery ofsamplesperproject milestones.
- Track and report on sample management status and address issues proactively.
- Lead innovation and process improvement activities for Biosample Operations and/or Clinical Operations functions.
The Necessities
At Entrada our passion for science our devotion to patients and our values drives ourbehavior:
- Humanity We genuinely care about patients and about one another.
- Tenacity We are relentless and persistent in the pursuit of developing therapiesfor patients.
- Creativity We are creative problem solvers.
- Collaboration We are more than the sum of our parts.
- Curiosity We have a growth mindset and push conventional thought and theory.
To thrive on our team you will need to come with:
- Bachelors degree preferably in a scientific or healthcare field or equivalent combined education with 7 years of overall clinical operations experience and 4 years of experience directly in biosample operations.
- Indepth understanding of clinical trial processes from study startup through study closure related to sample collection logistics transit storage central tracking and global requirements.
- Excellent knowledgeof ICH GCPand GLP
- Proven ability to independently problemsolve and establish prioritieswork with a strongsense of urgency and collaborateeffectivelywith the study team crossfunctional team members and external partners/vendors across multiple projects and deadlines.
- Advanced project management skills with the ability to identify risks and issues as well as propose appropriate measures as required.
- Strong interpersonal and negotiation skills as well as strong verbal and written communication.
- This is a US based remote position with a strong preference given to local New England based candidates. This role will require minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston MA. Ability and willingness to travel 10 (domestic/international) is required. #LIJF1 #LIRemote
The Perks
By becoming a team member here at Entrada youll have access to competitive health dental and vision coverage as well as life insurance and short term and longterm disability insurance. We value work life balance youll benefit from discretionary time off paternity leave and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.
Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race color religion national origin gender sexual orientation gender identity or expression age mental or physical disability and genetic information marital status citizenship status military status protected veteran status or any other category protected by law.
Third Party Staffing Agencies
Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.
Privacy Statement
Entrada Therapeutics Inc. (the Entrada we us or our respects your privacy and we want you to be familiar with how we collect use share or otherwise process your Personal Information. Please reference our privacy statement here to understand how and when your data is being used.
Required Experience:
Senior Manager
Employment Type
Full Time
