Senior Director, Head of Clinical Science
Senior Director, Head of Clinical Science
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Job Description
Bicycle Therapeutics is seeking a motivated professional with oncology experience to serve as Senior Director and Head of Clinical Science in its Cambridge Massachusetts office. This role sits within a growing clinical department working to advance highly novel Bicycle (bi-cyclic peptide) therapeutics including drug conjugates. The Head of Clinical Science will report into the SVP Clinical Development. This person will interact closely with the medical directors clinical operations regulatory biostatistics and translational groups to facilitate both early and late phase studies clinical data monitoring and analysis regulatory and development strategy. He/she will assume line management responsibilities for the Clinical Scientists. They may take on direct clinical science responsibilities on specific projects as required.
Key Responsibilities
- Ensure adequate clinical science support to the different programs in Oncology
- Manage support and train the Clinical Science Team
- Ensure the quality of the study protocols by providing adequate clinical science resources and review for the different programs
- Ensure appropriate and timely clinical science support to regulatory interactions
- Participate in the development strategy by stimulating data circulation and exchange of ideas across development functions.
- Bring strategic concepts into development by supporting advisory boards and expert consultations
- Lead and support internal initiatives to develop best practices lessons-learned problem-solving and risk mitigation. Particularly contribute to process optimization for clinical data monitoring and analysis
- Contribute to publication strategy and preparation of abstracts posters and manuscripts
- Provide direct clinical science support on dedicated programs as needed:
- Medical surveillance and analysis of clinical data working closely with the study team and medical monitors
- Serve as a liaison between clinical sites CRO medical monitors and investigators
- Assist in organizing preclinical clinical literature conference-based and competitive data to generate development plans
- Participate in operational excellence projects as appropriate and audit readiness activities
- Collaborate with study team members (Clinical Operations Data Management Statistics Drug Safety Regulatory Affairs Translational Medicine and Project Management) to ensure that key milestones are met on time and with high quality data output
- Assist in advisory boards conference activities external collaborations and partnerships
- Active contributor to Investigator Meetings study committees (e.g. IDMC) and Site Initiation Visit presentations
- Prepare and assist in safety reviews dose escalation meetings annual reports SAE narratives and trend analyses
- Assist in clinical trial protocol drafts study reports amendments informed consent forms investigator brochures INDs briefing books and other regulatory documents taking an active part in strategy design authoring and discussion
- Work closely with team members to ensure efficiency clarity and consistency in documents and plans
Qualifications :
Essential:
- Life sciences MS or PhD or advanced health degree such as nursing or pharmacy
- Experience in clinical science reflecting increasing responsibilities and positions of leadership in the biopharmaceutical industry preferably in oncology
- Clinical study design data collection analysis and data interpretation skills
- 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
- Willingness and ability to support and develop a team of clinical scientists
- Knowledge of Good Clinical Practice (GCP) and basic regulatory principles
Desirable:
- Prior experience leading clinical science department
- Knowledge and experience of translational science
- Experience working on registrational trials and registrational application and approval process
- Prior line management experience of clinical scientists or group leadership of clinical science department
Additional Information :
- Flexible working environment
- Competitive reward including annual company bonus
- Medical dental and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company
- Health and Dependent Care Flexible Spending Accounts
- 401(k) plan with a 4% Company match and immediate vesting
- Eligibility to accrue up to 23 paid time off days per full year worked plus the option to buy up to 5 additional days
- Employee assistance program
- Employee recognition schemes
- 10 Company holidays
- Competitive Family Leave Policy
- Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
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.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
