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    Manager, Drug Safety - Cambridge, United Kingdom - Bicycle Therapeutics

    Bicycle Therapeutics
    Bicycle Therapeutics Cambridge, United Kingdom

    2 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics.

    Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry.

    This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development.

    The company is evaluating BT8009, a Bicycle Toxin Conjugate (BTC) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials.

    Additionally, the company is developing Bicycle Radio Conjugates (BRCTM) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle technology to develop therapies for diseases beyond oncology.

    Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA.

    Culture is key and all Bicycle employees actively embrace and role model our company values:
    We are Adventurous . We believe it's the way to deliver extraordinary results for our patients.
    We are Dedicated to our Mission . You can't change the world if you don't have determination
    We are One Team . We only succeed when we work together.

    Job Description

    We have a new opportunity within our Drug Safety function for a Manager, Drug Safety.
    This roleprovides clinical safety and pharmacovigilance support to medicines across life-cycle.

    Reporting to the Head of Drug Safety, you will oversee the drug safety operation and compliance activities for the development programmes and ensuring inspection readiness.


    Key responsibilities:


    Serve as the main point of contact for the drug safety operation activities in liaison with external clinical trial vendors and internal cross functional teams.

    Responsible for maintaining and oversight of regulatory safety reporting compliance.
    Effective monitoring and tracking of serious adverse events (SAEs), SUSARs and aggregate reports, including scientific literature.

    Oversight & tracking of reconciliation of SAEs between clinical and safety database in close collaboration with data manager and trial CROs, and escalate any issues for prompt resolution.

    Laise closely with the Bicycle quality function and act as drug safety point of contact for inspection readiness initiatives, and effective participation in CAPA generation as required.

    Provide input and track the generation of project specific plans such as but not limited to Safety Management Plans (SMP) or SAE Reconciliation plans, in close cooperation with project team during set-up and maintenance phase
    Reviews and track CRO/vendor compliance reports, and presentation to cross functional teams as required.
    In liaison with external vendors, maintain trial master file for safety related documentation in a timely manner
    Responsible for departmental initiatives, set up processes & tools for regulatory compliance tracking and effective monitoring. Lead investigation of drug safety process related issues as appropriate.
    Support safety surveillance activities, and act as back to team members.
    Manage meeting minutes, filing and tracking as required with external and internal stakeholders
    Assists with development and maintenance of Bicycle Drug Safety SOPs.
    Monitors assigned project to assure company quality and associated project goals and objectives are being met

    Qualifications

    Educated within relevant subject mattersor equivalent career experience
    Experiencewithinin drug safety and pharmacovigilance including project management in the pharmaceutical industry/CROs
    Experience in participating in audits and inspections is preferable
    Experience with use of safety databases, preferably Argus but not compulsory
    Working knowledge of ICH, EU, FDA and other international PV regulations.
    Experience in the tracking and scheduling of aggregate reports
    Excellent verbal and written communication skills
    Exceptional teamwork skills and ability to work independently
    Proficiency in standard desktop software programs (Word, Excel, PowerPoint, Outlook)

    Additional Information

    State-of-the-art campus environmentwith on campus restaurant and Montessori nursery
    Flexible working environment
    Competitive reward including annual company bonus
    Employee recognition schemes
    28 days annual leave in addition to bank holidays+ option to buy up to 5 additional days annually
    Employer contribution to pension (employee does not have to contribute)
    Life assurance cover 4x basic salary
    Private Medical Insurance, including optical and dental cover.
    Group income protection
    Employee assistance program
    Health Cash Plan
    Access to company subsidized gym membership.
    Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
    Cycle to work scheme
    Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company.

    Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.

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