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Associate Director, Clinical Scientist
4 months ago
Bicycle Therapeutics is seeking a motivated professional with oncology or immunology experience to serve as a Clinical Scientist (Associate Director) to provide scientific support for all clinical development activities involving the conduct of clinical studies. This role sits within the clinical department working to advance Bicycle Toxin Conjugates and Bicycle Immune Agonists as novel cancer therapeutics. The Clinical Scientist will report to the Head of Clinical Sciences within clinical development and closely interact with the medical director(s) as well as with the biostatistics, regulatory, translational, and discovery/preclinical groups to facilitate execution of early phase studies and development of next phase clinical trials. This position will interface externally with study sites, investigators, advisors, and contract research organizations (CROs).
- Responsible for clinical study design and conduct for development of novel tumor antigen-targeted Bicycle therapeutics
- Participate in strategy, design, authoring, and review of clinical documents, including protocols, amendments, informed consent forms, clinical study reports, investigator brochures, drug safety update reports, and clinical development plans
- Lead medical and safety data review and associated meetings in collaboration with the Medical Monitor, review and query data
- Participate in study start up, including identification of investigators/sites, feasibility, review of CRF, etc
- Develop content and give presentations during site initiation visits; participate in site training
- Serve as a liaison between study team, CROs, and investigators
- Track study progress and metrics related to emerging clinical data
- Contribute to regulatory documents, including INDs and briefing books and other regulatory documents
- Enable translational medicine by working closely with biomarker and discovery scientists
- Perform literature searches and critically review and summarize results to support activities such as document development, new indications for a given molecule, and competitive intelligence
- Contribute to publication strategy and provide support for publication of data
- Assist in preparing material for advisory boards, conference activities, external collaborations, and partnerships
- Support internal initiatives to develop best practices, lessons-learned, problem-solving, and risk mitigation
- Potential to mentor other clinical scientists
- Attend congresses as needed to support publications as well as interactions with key opinion leaders and investigators
- Life sciences MS or PhD or health degree such as nursing or pharmacy
- Extensive experience working as a clinical scientist in oncology
- Clinical study design, data collection, analysis, and data interpretation skills
- Knowledge of Good Clinical Practice (GCP) and basic regulatory principles
- Experience with technical writing for scientific, regulatory, and/or clinical documents
- Excellent written, oral communication and presentation skills
- Strong interpersonal skills and can-do attitude with flexibility and ability to adapt
- Critical thinker who is proactive with a highly collaborative style and team-focused approach
- 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
All your information will be kept confidential according to EEO guidelines.
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.
