Director / Senior Director Drug Safety Physician

Company Description

Bicycle Therapeutics is a clinical-stage pharmaceutical 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 zelenectide pevedotin (formerly BT8009), a Bicycle® Drug Conjugate (BDC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC molecule 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® Radioconjugates (BRC®) 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, 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 (e.g. disease under study, safety profile of competitors, mechanism(s) of action etc)
• Chair the respective Safety Surveillance Teams for assigned product(s) in collaboration with internal cross-functional experts (e.g. Clinical development, regulatory, clinical pharmacology, toxicology etc), defining the Safety Signal Detection Plans including the Adverse Events of Special Interest (AESIs), leading regular routine reviews of emerging safety data (AEs, lab data, relevant literature and non-clinical data etc), and ensuring safety signal detection and evaluation
• Ensure decision-making and timely presentation of important/urgent safety issues together with risk communication/management strategies to the company senior management and other internal and external stakeholders (e.g. the Drug Safety Committee, and Independent Data Safety Monitoring Boards)
• 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 and ensuring implementation of risk mitigation measures
• Working with cross functional colleagues or external vendors, provide medical safety expertise to ensure the medical safety integrity and quality of study-specific documents (e.g. protocols, IBs, ICFs, CRFs, IMPDs, SAPs, clinical study reports, INDs, CTAs), periodic safety reports (e.g. DSURs, periodic line listings), investigator communications, external publications and other documents, as required
• Provide oversight of clinical safety activities including those performed by external PV vendors and study Medical Monitors including review of MedDRA coding of AEs, and assessment of SAEs and AESIs including preparation of analyses of similar events (AOSE) for unexpected and related serious adverse events (SUSARs) from clinical trials
• Working with external PV vendors, ensure timely, compliant, and accurate safety reporting in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and Bicycle Standard Operating Procedures (SOPs)
• Lead responses to safety questions from regulatory authorities, and support regulatory agency meeting and interactions, 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 as required, to ensure the 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 Health Authority inspections
• Present safety-related data, information 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 relevant concepts in data management and systems, statistics and epidemiology
• Ability to understand science and biology and understand the significance of preclinical findings when applied to use in man
• Confident expert in drug safety with effective leadership skills, able to command respect and influence decision-making
• Strong work ethic
• Problem-solving and decision-making skills
• Able to identify risks and propose actions in complex and critical situations
• Able to work independently and within cross-functional teams to provide key input to difficult or sensitive projects
• Willingness to challenge and be challenged to ensure optimal decision-making and delivery of solutions for patients
• Curiosity and a solution-driven approach to challenges
• Able to manage multiple and/or complex programs and coordinate the production of complex deliverables
• Excellent communication skills, oral and written – ability to present information clearly and precisely
• Ability to mentor and supervise less experienced members of Drug Safety and Pharmacovigilance

Additional Information

•State-of-the-art campus environment with 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
•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.