VP, Head of Drug Safety

2 weeks ago

Ely, United Kingdom Bicycle Therapeutics Full time

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 (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, 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

Reporting to the Chief Development Officer, the VP, Drug Safety & Pharmacovigilance will be responsible for leading the overall strategic direction for Safety and Pharmacovigilance and, through leadership of the team, oversee the operational delivery of safety and pharmacovigilance activities at Bicycle.

You will be a highly experienced and visionary member of the Development Leadership Team and will actively contribute to the broader clinical development strategy.

Key responsibilities

Develop and implement a comprehensive drug safety & pharmacovigilance strategy aligned with Bicycle’s overall mission and goals

Collaborate with senior executives to integrate drug safety & pharmacovigilance considerations into overall business strategies, clinical development plans and broader decision-making processes

Manage and lead the patient safety and pharmacovigilance function including oversight for activities, operations, and continued evolution toward a best-in-class organization

Accountable for ensuring that appropriate resources, systems and processes are in place for the evaluation and reporting of safety information, and other responses, to meet applicable global regulatory requirements for all programs

Provide expert guidance and decision-making and will help to shape the strategy and direction of the global function to meet the organizational needs and contribute toward the overall R&D strategy

Work with key stakeholders within the organization to develop safety and PV strategy for current products under development including proactively identifying and communicating emerging potential and/or urgent safety issues and to support signal detection and risk/benefit evaluation.

Provide oversight of Serious Adverse Event (SAE) processing and ensure timely, compliant, and accurate safety reporting in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and standard operating procedures (SOP).

Maintain expert knowledge of current ICH and health authority requirements, expectations, and trends in patient safety and pharmacovigilance, and ensure compliance in all activities. Ensure readiness for health authority inspections and partner audits, and represent Spark in inspections, audits, and other health authority meetings as required.

Design, direct, and conduct ongoing safety surveillance of company drug products using internal and external resources to ensure delivery of high-quality pharmacovigilance services.

Ensure risk management/reduction strategies are developed and included in relevant documents such as clinical study protocols.

Represent Bicycle in interactions with regulatory agencies, industry consortia, and external stakeholders on drug safety matters

Monitor industry best practices and changes in global safety regulations and guidelines.

Provide direction and leadership for departmental policies, SOPs, systems, communications, reporting e.g., DSUR, PSUR, periodic line listings) and vendor selection/management to ensure global regulatory compliance.

Qualifications

Medical Doctor (MD/MBBS/DO) degree

Significant global drug safety/pharmacovigilance experience, including experience in developing systems and processes for handling, processing, analysis, and regulatory reporting of adverse event reports, including serious adverse events

Significant people leadership experience, proven track record of successfully leading, developing and motivating teams

Exceptional ability to influence and inspire others, build strong relationships, and drive consensus across diverse stakeholders

Direct experience in interacting with regulatory authorities

Ability to formulate and articulate a clear and compelling vision for drug safety and PV that aligns with Bicycle’s long-term goals

Experience of taking an active leadership role within a development function, acting as a business leader (beyond solely representing Drug Safety/PV); collectively as a leadership team determining long-term strategic clinical development plans

Accustomed to influencing and interacting with Executive team and Board

Outstanding interpersonal and communication skills both written and oral and ability to communicate complex information clearly, succinctly and persuasively

Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external stakeholders

Demonstrated ability to thrive in a fast-paced, dynamic environment and manage multiple priorities effectively

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

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.

  • Head Chef

    3 weeks ago

    Ely, United Kingdom Loungers Full time

    Head Chef - ElyIf you are looking for a Head Chef opportunity within a fresh food, fast paced environment, then you have found it!You might be a Sous Chef looking for your first step into becoming a Head Chef or an experienced Head Chef or Kitchen Manager looking for your next role. We want someone who takes real pride in what they're serving and the team...

  • Head Chef

    2 weeks ago

    Ely, United Kingdom Loungers Full time

    Head Chef - ElyIf you are looking for a Head Chef opportunity within a fresh food, fast paced environment, then you have found it!You might be a Sous Chef looking for your first step into becoming a Head Chef or an experienced Head Chef or Kitchen Manager looking for your next role. We want someone who takes real pride in what they're serving and the team...

  • Head Chef

    2 weeks ago

    Ely, United Kingdom Loungers Full time

    Head Chef - ElyIf you are looking for a Head Chef opportunity within a fresh food, fast paced environment, then you have found it!You might be a Sous Chef looking for your first step into becoming a Head Chef or an experienced Head Chef or Kitchen Manager looking for your next role. We want someone who takes real pride in what they're serving and the team...

  • Head Chef

    4 weeks ago

    Ely, United Kingdom Loungers Full time

    Head Chef - ElyIf you are looking for a Head Chef opportunity within a fresh food, fast paced environment, then you have found it!You might be a Sous Chef looking for your first step into becoming a Head Chef or an experienced Head Chef or Kitchen Manager looking for your next role. We want someone who takes real pride in what they're serving and the team...

  • Head Chef

    3 weeks ago

    Ely, United Kingdom Loungers Full time

    Head Chef - ElyIf you are looking for a Head Chef opportunity within a fresh food, fast paced environment, then you have found it!You might be a Sous Chef looking for your first step into becoming a Head Chef or an experienced Head Chef or Kitchen Manager looking for your next role. We want someone who takes real pride in what they're serving and the team...

  • Head Chef NEW PROCESS

    2 weeks ago

    Ely, United Kingdom Lounges Full time

    If you are looking for a Head Chef opportunity within a fresh food, fast paced environment, then you have found it! You might be a Sous Chef looking for your first step into becoming a Head Chef or an experienced Head Chef or Kitchen Manager looking for your next role. We want someone who takes real pride in what they're serving and the team they're...

  • Head Chef

    2 weeks ago

    Ely, United Kingdom Lounges Full time

    Exciting opportunity for a Head Chef to join this new opening and become part of one of the most successful restaurant groups in the UK. You might be a Sous Chef looking for your first step into becoming a Head Chef or an experienced Head Chef or Kitchen Manager looking for your next role. We want someone who takes real pride in what they're serving and...

  • Head Chef

    3 weeks ago

    Ely, United Kingdom Loungers Full time

    Head Chef - New Opening - ElyExciting opportunity for a Head Chef to join this new opening and become part of one of the most successful restaurant groups in the UK.You might be a Sous Chef looking for your first step into becoming a Head Chef or an experienced Head Chef or Kitchen Manager looking for your next role. We want someone who takes real pride in...

  • Head Chef NEW PROCESS

    1 week ago

    Ely, United Kingdom Loungers Full time

    Head Chef NEW PROCESS - ElyIf you are looking for a Head Chef opportunity within a fresh food, fast paced environment, then you have found it!You might be a Sous Chef looking for your first step into becoming a Head Chef or an experienced Head Chef or Kitchen Manager looking for your next role. We want someone who takes real pride in what they're serving and...

  • Head Chef

    2 weeks ago

    Ely, United Kingdom Loungers Full time

    Head Chef - New Opening - ElyExciting opportunity for a Head Chef to join this new opening and become part of one of the most successful restaurant groups in the UK.You might be a Sous Chef looking for your first step into becoming a Head Chef or an experienced Head Chef or Kitchen Manager looking for your next role. We want someone who takes real pride in...

  • Head Chef NEW PROCESS

    6 days ago

    Ely, United Kingdom Loungers Full time

    Head Chef NEW PROCESS - ElyIf you are looking for a Head Chef opportunity within a fresh food, fast paced environment, then you have found it!You might be a Sous Chef looking for your first step into becoming a Head Chef or an experienced Head Chef or Kitchen Manager looking for your next role. We want someone who takes real pride in what they're serving and...

  • Head Chef

    3 weeks ago

    Ely, United Kingdom Loungers Full time

    Head Chef - New Opening - ElyExciting opportunity for a Head Chef to join this new opening and become part of one of the most successful restaurant groups in the UK.You might be a Sous Chef looking for your first step into becoming a Head Chef or an experienced Head Chef or Kitchen Manager looking for your next role. We want someone who takes real pride in...

  • Head Chef

    3 weeks ago

    Ely, United Kingdom Loungers Full time

    Head Chef - New Opening - ElyExciting opportunity for a Head Chef to join this new opening and become part of one of the most successful restaurant groups in the UK.You might be a Sous Chef looking for your first step into becoming a Head Chef or an experienced Head Chef or Kitchen Manager looking for your next role. We want someone who takes real pride in...

  • Head Chef

    2 weeks ago

    Ely, United Kingdom Loungers Full time

    Head Chef - New Opening - ElyExciting opportunity for a Head Chef to join this new opening and become part of one of the most successful restaurant groups in the UK.You might be a Sous Chef looking for your first step into becoming a Head Chef or an experienced Head Chef or Kitchen Manager looking for your next role. We want someone who takes real pride in...

  • Head Chef

    20 hours ago

    Ely, United Kingdom Loungers Full time

    Head Chef - New Opening - ElyExciting opportunity for a Head Chef to join this new opening and become part of one of the most successful restaurant groups in the UK.You might be a Sous Chef looking for your first step into becoming a Head Chef or an experienced Head Chef or Kitchen Manager looking for your next role. We want someone who takes real pride in...

  • Horticulture & Gardening Apprenticeship

    4 weeks ago

    Ely, United Kingdom LMP Group Full time

    Brief overview of this role To support our head gardener with tasks in the garden. We need to keep our gardens neat, tidy and presentable as this reflects us as a business. Weeding, planting, watering, dead heading, digging, pruning, lawn mowing, etc. Basically caring for an over sized private garden with borders and large lawns. Full vacancy description -...

  • Horticulture & Gardening Apprenticeship

    1 day ago

    Ely, United Kingdom LMP Group Full time

    Brief overview of this role To support our head gardener with tasks in the garden. We need to keep our gardens neat, tidy and presentable as this reflects us as a business. Weeding, planting, watering, dead heading, digging, pruning, lawn mowing, etc. Basically caring for an over sized private garden with borders and large lawns. Full vacancy description -...

  • Gardener

    4 weeks ago

    Ely, United Kingdom Kings Ely Full time

    The Gardener reports to the Head Gardener on a daily basis. The main responsibility of the Gardener is to maintain and develop the gardens across the 70-acre School grounds. - To maintain and develop the gardens to an exceptionally high standard. - To undertake tasks including, but not limited to, propagation, seeding, planting, weeding, bed preparation,...

  • Gardener

    3 weeks ago

    Ely, United Kingdom Kings Ely Full time

    The Gardener reports to the Head Gardener on a daily basis. The main responsibility of the Gardener is to maintain and develop the gardens across the 70-acre School grounds. - To maintain and develop the gardens to an exceptionally high standard. - To undertake tasks including, but not limited to, propagation, seeding, planting, weeding, bed preparation,...

  • Qhse & Facilities Administrator

    6 days ago

    Ely, United Kingdom Akton Recruitment Ltd Full time

    Akton are recruiting on behalf of a client who are looking for someone to work part-time, ideally for 5 hours per day, to handle the administration of QHSE Management System documents, records, spreadsheets, and calendars. The role will include: - General administration of departmental documentation - Maintenance of the Company's Legal Register - Organise...