Company Description
Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, Bicycle molecules. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry and enable target binding with high affinity and selectivity. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle Drug Conjugate (BDC) targeting Nectin-4; BT5528, a BDC molecule targeting EphA2; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA) targeting Nectin-4 and CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle Radioconjugates (BRC) for radiopharmaceutical use and, through partnerships, is exploring Bicycle technology for diseases beyond oncology.
Bicycle Therapeutics is headquartered in Cambridge, UK, with key functions and leadership located in Cambridge, Massachusetts, USA. For more information, visit bicycletherapeutics.com
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
* Accountable for leading the safety aspects of the design, implementation, execution, and management of pharmacovigilance and risk management activities for assigned compounds in line with the Company’s development and planned commercial activities, industry standards, and in full compliance with global regulations
* Accountable for providing medical expertise to safety decision-making across the life-cycle of Bicycle products
* Ensure medical safety integrity, quality and patient-focus for all relevant clinical development activities and deliverables
* Effectively represent Drug Safety and Pharmacovigilance as a core member of assigned Global Product Teams, and in other applicable cross-functional activities (e.g. clinical development, clinical pharmacology, toxicology and regulatory)
* Lead safety signal management and risk management, and provide expertise to benefit-risk assessments for all assigned products
* Ensure medical safety intelligence re the respective therapeutic area landscapes including comparator/competitor products (e.g. changes to reference safety information, new safety signals and risks, newly available safety data in publications etc), and treatment guidelines
* Detailed Activities
* Develop and maintain an expert understanding of the safety profiles of the assigned products, as well as an understanding of the relevant strategic context
* Chair the respective Safety Surveillance Teams for assigned product(s) in collaboration with internal cross-functional experts, defining the Safety Signal Detection Plans including AESIs, leading regular routine reviews of emerging safety data, and ensuring safety signal detection and evaluation
* Ensure decision-making and timely presentation of important safety issues together with risk communication/management strategies to senior management and other stakeholders
* Lead safety risk management activities for assigned product(s) in clinical development, including defining and characterizing the safety profile with identified and potential risks, contributing to overall benefit-risk assessment, and proposing risk mitigation measures
* Work with cross-functional colleagues or external vendors, provide medical safety expertise to ensure the medical safety integrity and quality of study-specific documents and safety reports
* Provide oversight of clinical safety activities including review of MedDRA coding of AEs, assessment of SAEs and AESIs, and preparation of analyses for SUSARs
* Collaborate with external PV vendors to ensure timely, compliant safety reporting in accordance with regulatory requirements, GCP, and Bicycle SOPs
* Lead responses to safety questions from regulatory authorities, and support regulatory agency meetings, including development/review of Briefing Books
* Lead the development of Health Hazard Evaluation Reports for Product Quality Concerns
* Assist in preparation/update of safety-related global SOPs to ensure efficient operation of the drug safety function and PV System
* Provide expertise for the development and implementation of CAPAs as required to sustain the PV Quality System
* Maintain knowledge of and ensure compliance with company guidelines, policies and procedures and be able to demonstrate this during audits and inspections
* Present safety-related data and messages to internal and external audiences as required
Qualifications
Essential:
* Degree in medicine (MD, MBBS or equivalent)
Ideal:
* Post-graduate medical qualification, e.g. MRCP, MRCGP
* Specialist accreditation with the UK GMC in Pharmaceutical Medicine
Required Professional Experience
* Clinical experience in a hospital or community-based healthcare environment
* Expertise and good practical knowledge of all phases of drug development from FIM to post-approval
* Demonstrable experience in clinical safety, pharmacovigilance, and risk management within the biotech/pharmaceutical industry
* Good knowledge of relevant ICH Guidelines and local regulations (e.g. FDA, EU, UK)
* Proven evidence of effective delivery of high-quality technical documents
* Good working knowledge of data management and systems, statistics and epidemiology
* Ability to understand science and biology and apply preclinical findings to human use
* Confident expert in drug safety with leadership skills and the ability to influence decision-making
* Strong work ethic and problem-solving abilities
* Able to identify risks and propose actions in complex situations
* Able to work independently and within cross-functional teams
* Willingness to challenge and be challenged to ensure optimal decision-making
* Curiosity and a solution-driven approach to challenges
* Able to manage multiple and/or complex programs and deliverables
* Excellent communication skills, both oral and written
* Ability to mentor and supervise less experienced Drug Safety and Pharmacovigilance staff
Additional Information
* State-of-the-art campus environment with on-site 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, with option to buy up to 5 additional days
* Employer contribution to pension
* Life assurance cover 4x basic salary
* Private Medical Insurance, including optical and dental cover
* Enhanced parental leave policies
* 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.
#J-18808-Ljbffr