Job Description

The Associate Director of Biostatistics will be a key member of the Biometrics function with accountability for biostatistical activities in Bicycle clinical studies. In addition to the oversight on Biostatistics counterpart from vendors, you will provide key biostatistical input and quantitative deep thinking to support a wide variety of projects in clinical development. The Associate Director of Biostatistics will closely collaborate with partner functions such as Medical, Clinical Research, Clinical Operation, Data Management, Statistical Programming, etc. This position reports to the Director of Biostatistics.

The ideal candidate has demonstrated advanced expertise in Biostatistics, comprehensive working experience in clinical studies, preferably in Oncology therapeutic area, as well as strong leadership.

• Responsible for all biostatistical deliverables on project teams in multi-disciplinary interactions
• Serve as in house biostatistics point of contact at clinical study level, provide review and approval for statistical documents and other relevant study documents as needed, oversight vendor biostatistical work to ensure high quality.
• Provide statistical expertise to support protocol development, study set up and conducting; author or peer review Statistical Analysis Plan (SAP); review data specifications and TFL shell; provide statistical QC as needed; co-author or peer review clinical study report and publications.
• Provide support as needed to ensure efficient action, collaboration, and resolution of biostatistical issues.
• Conduct statistical analysis and/or statistical simulations to support clinical decision making

Qualifications

Essential:  

• Ph.D degree in Statistics or Biostatistics with experience in the pharmaceutical or biotechnology industry
• Good Clinical Practice (GCP) proficient
• Advanced knowledge of Biostatistics related to clinical development and clinical studies.

Desirable:  

• Proficient programming skills using R and SAS. In-depth experience on statistical simulations
• Ability to independently manage multiple projects, strong problem-solving skills, and excellent teamwork spirit
• Excellent communication skills, both written and verbal

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Job Description

We are looking for a Manager, Clinical Outsourcing. The right candidate will possess an understanding of Clinical Outsourcing activities for successful execution of multiple clinical trials primarily in oncology indications in various phases of development. In addition, this candidate will oversee the vendor selection and contracting processes with CROs, Central laboratory, Imaging, IRT and other suppliers as assigned.  They will support the development building of the infrastructure of the Clinical Outsourcing group and provide overall subject matter expertise on outsourcing and contracting practices.

The position will be a member of the Clinical Operations group, reporting to the Director, Clinical Outsourcing and Business Operations.

• Manages the identification and selection process of clinical vendors such as CROs, central labs, imaging,
• Supports the creation and management of preferred provider relationships, functional service provider, negotiated rate cards, volume discounts, etc.
• Collaboratively creates and issues Request for Proposals (RFPs), compiles responses and facilitates team review of proposals from suppliers.
• Participates in pricing negotiations for CROs and other critical study vendors.
• Leads and facilitates cross functional review vendor selection meetings
• Manages work order amendments and change orders to ensure appropriate pricing and timely execution
• Facilitates and leads vendor governance meetings with key CRO and vendor partnerships.
• Collaborated with global clinical teams and preferred suppliers to analyze trends, assess performance, improve efficiencies, leverage resources, and reduce costs,
• Reviews metrics and Key Performance Indicators (KPIs) to ensure oversight of clinical trial progress and participates in quality review of vendor performance.
• Liaises with key functions including Clinical Operations, Finance, Legal, Biostatistics, PV, QA, Data Management, and Clinical Development to ensure appropriate stakeholder engagement in vendor selection and management.
• Work closely with finance to assure the assumptions for studies are aligned between finance and clinical forecasting.
• Collaborates with Clinical Operations, Global Project Management, Quality Assurance and IT, as well as other cross-functional teams as needed, to provide management support and guidance regarding the identification, selection and management of potential new business processes and systems (eg; CTMS, TMF, Grant Management) in Clinical Operations and Clinical Development as assigned
• Supports the development and maintaining RFP templates, Change Order and Change Notification Form trackers, Confidentiality Agreements (CDAs), Master Service Agreements (MSAs) and project-specific agreements as assigned.
• Ensures awareness of trends in the industry in the field of innovation in pharmaceutical clinical trials by scanning internal and external operational trends and evaluating new innovative platforms and practices
• Supports the development of the Clinical Outsourcing department infrastructure with assisting in developing process documents, input to SOPs, and provide training to others. 
• Provide review of quarterly and monthly financial reviews from the CROs and other vendors, and monitor

Qualifications

• Minimum Education Required: Bachelor’s degree in scientific or business discipline.
• Experience in vendor and contract management with a sponsor company or CRO managing various phase clinical trials. 
• Experience in CRO, vendor and laboratory selection and oversight.
• Experience in contracts, legal agreements, and financial budgeting preferred.
• Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
• Creative problem solver with excellent communication and public speaking skills.
• Strong interpersonal and organizational skills are needed, with a high degree of attention to detail.  Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Project leader, Physician, Finance, QA etc.).
• Strong analytical and problem-solving skills
• Excellent written and oral communication skills
• Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint)
• Flexible approach to change

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Job Description

The Senior Director, Global Scientific Communications & Publications is a key member of the Medical Affairs leadership team and will be responsible for leading Bicycle’s medical affairs communications strategy and processes, which include the development and execution scientific publications and communications. This role is responsible for cultivating partnerships with cross-functional senior and executive leaders in clinical, program management, corporate communications, investor relations, legal, regulatory, patient advocacy, and commercial to drive a data communication strategy and advance the awareness/understanding of the Bicycle portfolio. This individual will be an experienced people manager, who will lead and be responsible for the company’s publication strategy/review, scientific communications, and medical information processes. Developing effective collaboration and communication processes with internal and external stakeholders will be a key component of this role. This position will report into the VP, Head of Global Medical Affairs.

• Lead the development and execution of annual and long-range publication/scientific communication strategies and tactics to support the Bicycle portfolio
• Provide strategic oversight and improve processes for the development/review of publications (i.e., abstracts, presentations, manuscripts), scientific communication materials, congress materials, and omnichannel amplification activities
• Build and maintain collaborative relationships with senior leadership to ensure alignment of medical communications and publications with corporate strategy and business objectives
• Ensure medical affairs scientific communications are aligned with cross-functional stakeholders to create consistency in scientific messages and narratives
• Assure close but appropriate coordination of medical affairs publication and scientific communication activities with medical affairs functions, clinical, commercial, translational, research, corporate communications, investor relations, and other key Bicycle stakeholders
• Establish Medical Affairs publications, communications, and Medica/Legal/Regulatory (MLR) review standard operating procedures
• Oversee and improve publication strategy and review process with the goal of an integrated publication strategy and plan across Bicycle programs
• Establish and ensure consistent adherence to good publication and authorship practices
• Lead strategic scientific communication planning, including the development of scientific narratives/messages, lexicons, FAQs/backgrounders, and advisory board content
• Provide oversight of the medical information function, including the implementation of a global medical information system and resources to support Bicycle medical information needs
• Conduct ongoing assessments of medical communication and publication capabilities

Qualifications

• Prior biopharmaceutical industry experience is required (10+ years of experience preferred) in medical affairs and oncology publication development
• Advanced degree in health-related field (MD, PhD, or PharmD preferred)
• Strong leadership skills with track-record of building and managing effective teams
• Successful track-record of developing peer-reviewed publications is required
• Advanced understanding of the opportunities and challenges in publications, medical communications, and medical information
• Ability to think strategically and develop scientific publication and communication strategies
• Ability to navigate and succeed in a dynamic, fast-paced environment with a high degree of collaboration and teamwork
• Open, engaging, and transparent with the ability resolve conflict
• Global perspective with ability to work with stakeholders from various cultures and geographies
• Strong business acumen with the ability to prioritize
• Ability to effectively manage scientific communication, publication, and medical information vendors
• Proficiency in clinical data review and interpretation with the ability to simplify scientific messages
• Excellent interpersonal communication skills, written and verbal, and customer-focused approach
• Experience developing and delivering presentations, utilizing PowerPoint slides
• Knowledge of U.S. and ex-U.S. guidelines pertaining to data dissemination and HCP interactions
• Occasional business travel required (~20%)

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Job Description

The Senior Director, Global Medical Affairs Strategy is a key member of the Medical Affairs leadership team and will function as a scientific and medical expert for Medical Affairs, as well as other groups across the company. This individual will be responsible for developing and executing the overall global medical affairs strategy and tactical plans for the current and future Bicycle portfolio. This role will include overseeing the development of global medical affairs plans and cross-functional integrated evidence plans. This leader will provide strategic input into the Global Product Teams (GPTs), either directly or through oversight of the medical affairs representation on GPTs. The successful candidate will have a successful track record of developing and driving medical strategy for multiple assets, including the effective communication of scientific data through publications, medical communications, scientific engagement, advisory boards, congress activities, and medical information. In addition, the Senior Director will support data generation and life cycle management activities as well as develop relationships with global thought leaders in support of programs. This individual will be an experienced people manager, who will lead the global medical affairs strategy function and effectively collaborate across the company.

• Lead the development and execution of annual and long-range global medical affairs strategies and tactics to support the clinical development of the portfolio and prepare for future launch readiness
• Develop and execute strategy for the utilization of scientific data generated by preclinical, clinical, and Real-World Evidence (RWE) studies
• Establish the Global Medical Affairs Team (GMAT) structure and cadence at Bicycle to develop and execute on medical strategies and tactic
• Lead cross-functional GMAT teams directly or through oversight of other medical strategy team members to develop and implement integrated medical strategy for Bicycle products
• Ensure medical affairs strategy collaboration and strategic alignment with the field medical affairs team and support scientific communication material development to support KOL engagement
• Take accountability for the Investigator-Sponsored Trial (IST) strategy for Bicycle programs and serve as a key individual in the development, roll-out, and operation of IST programs
• Provide advice to the Medical, Legal, and Regulatory (MLR) review team and resolve escalations
• Assure close but appropriate coordination of medical affairs strategies and activities with clinical development, clinical operations, commercial, translational, research, corporate communications, investor relations, and other key Bicycle stakeholders
• Provide strategic oversight and assist as needed, in the development of publications (i.e., abstracts, presentations, manuscripts), integrated evidence plans, lifecycle management plans, congress plans, medical education plans, SOPs, ISTs, budgets, and RWE/HEOR plans\
• Present at scientific advisory boards and internal/external meetings

Qualifications

• Prior biopharmaceutical industry experience is required (10+ years of experience preferred) in medical affairs and oncology drug development
• Advanced degree in health-related field (MD, PhD, or PharmD preferred)
• Strong leadership skills with track-record of building and managing effective teams
• Ability to think strategically and translate scientific information into medical affairs strategies
• Ability to understand complex information and simplify into concise scientific messages
• Ability to navigate and succeed in a dynamic, fast-paced environment with a high degree of collaboration and teamwork
• Open, engaging, and transparent with ability resolve conflict
• Global perspective and mindset with ability work with colleagues and stakeholders from various cultures, backgrounds, and geographies
• Strategic thinking with strong business acumen and the ability to prioritize
• Excellent communication and presentation skills with the ability to influence key stakeholders
• Proficiency in clinical trial data review and interpretation
• Knowledge of U.S. and ex-U.S. healthcare systems
• Occasional business travel required (~25%)

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Job Description

The Associate Director of Data Management (DM) will act as the lead of one or several programs with accountability for all DM activities in Bicycle clinical studies including study set-up, capture/review/clean/delivery of clinical data and close-out. The Associate director of Data Management is responsible for timely and high-quality data management deliverables supporting the Bicycle Portfolio. The Associate Director of Data Management will report to the Director of Data Management.

The ideal candidate has a demonstrated strong expertise in Clinical Data Management, advanced working experience on clinical studies in Oncology therapeutic area, as well as contributing to influential leadership on DM activities to support clinical development, regulatory submissions, and inspections.

• Responsible for all DM deliverables as the program lead in multi-disciplinary interactions
• Provides strong quality and project oversight over third party vendor
• Responsible for data management deliverables by closely monitor data quality, timeline and actively identify and mitigate risks
• Efficiently plans, coordinates, and delivers complete high quality and reliable clinical trial data
• Responsible for end-to-end clinical data management activities including integration requirements (Oversee the design, building, testing and maintenance of clinical study database as well as oversight of data finalization and database lock activities)
• Represent Data Management on cross-functional project teams and submission teams.
• Serve as in house DM point of contact at program level, in all interactions with vendors, provide review and approval for both DM functional documents and other relevant study documents as needed. Provides oversight vendor DM work to ensure high quality
• Participates to best practices initiatives, identify the need, and participates to the creation of functional standard operating procedures and Work Instructions for DM function

Qualifications

• Master’s Degree preferred or bachelor’s degree with extensive years of DM work experience in the pharmaceutical or biotechnology industry required
• Good Clinical Practice (GCP) proficient
• Broad and advanced knowledge of DM and relevant disciplines related to clinical development and clinical studies
• Ability to independently manage multiple projects, strong problem-solving skills, and demonstrable leadership
• Excellent communication skills, both written and verbal

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Job Description

The role of Manager, Clinical Quality Assurance, supports Quality oversight for Bicycle’s development programs, ensuring compliance with applicable GLP and GCP standards and global regulations. This role is part of the Development Quality group, reporting to the Head of Development Quality.

As an integral member of the quality  team,  you will serve as a Quality and compliance business partner, engaging with multiple collaborators. You must be comfortable working independently, managing interactions with and between team members, both internally and externally.

Key responsibilities

• Partner with global program teams and supporting functions as required to advise on GLP and GCP  compliance,  proactively build quality into the operational activities
• Assist key stakeholders to  build inspection readiness to all stages of the development process
• Assist with the development and maintenance key quality indicators and introduce measurement of critical to quality factors, monitor performance against key KPIs both internally and across third parties.
• Ensure monitoring of quality performance indicators, identification of key quality events, escalation of issues and support follow up activities
• Support scoping of vendor evaluations and audits, contribute to reports and assist with follow up on assessment and partner with the business to  support the development of CAPAs.
• Educate and partner with key stakeholders on Deviation identification and reporting as well as risk appropriate remediation , RCA and CAPA management
• Assist functional area partners with development and documentation of CAPAs and effectiveness checks, as applicable.
• Support the development and maintenance of company Quality Management System (QMS) and integrated Learning Management System (LMS) and Controlled Document System as appropriate.
• Serve as POC for  QMS related training assignments for Development colleagues

Qualifications

• Relevant qualification within healthcare or Life Sciences or equivalent professional experience
• Demonstrable experience in Quality Assurance within the life sciences industry, ideally covering all clinical phases, with demonstrable experience in a GLP/GCP quality/compliance role
• Knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS)
• Strong familiarity with eTMF requirements
• Extensive experience managing deviations, RCA and CAPAs in a GLP /GCP environment
• Experience leading quality event investigations/ root cause analysis
• A thorough understanding of global drug development functional areas including preclinical, clinical, regulatory affairs and manufacturing
• Highly collaborative, strong relationship building skills with high level of integrity.
• Demonstrated ability to work proactively using solid communication and influencing skills to effectively execute program goals
• Exhibits flexibility and is a self-starter with a strong attention to detail
• Demonstrated ability to adapt working style to those of others for effective communication; able to multi-task and support multiple teams with varying levels of complexity
• Able to work effectively in highly complex and fast-paced environments
• Strong organizational and time management skills
• Familiarity with Electronic Document Management (EDM) systems and Microsoft Office suite
• Position requires both domestic and international travel up to 10% of time

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Job Description

The role of Manager, Quality, supports Quality oversight for Bicycle’s development programs, ensuring compliance with applicable GLP and GCPstandards and global regulations. This role is part of the  Development Quality group, reporting to the Head of Development Quality.

As an integral member of the quality  team,  you will serve as a Quality and compliance business partner, engaging with multiple collaborators. You must be comfortable working independently, managing interactions with and between team members, both internally and externally.

Key responsibilities

• Partner with global program teams and supporting functions as required to advise on GLP and GCP  compliance,  proactively build quality into the operational activities
• Assist key stakeholders to  build inspection readiness to all stages of the development process
• Assist with the development and maintenance key quality indicators and introduce measurement of critical to quality factors, monitor performance against key KPIs both internally and across third parties.
• Ensure monitoring of quality performance indicators, identification of key quality events, escalation of issues and support follow up activities
• Support scoping of vendor evaluations and audits, contribute to reports and assist with follow up on assessment and partner with the business to  support the development of CAPAs.
• Educate and partner with key stakeholders on Deviation identification and reporting as well as risk appropriate remediation , RCA and CAPA management
• Assist functional area partners with development and documentation of CAPAs and effectiveness checks, as applicable.
• Support the development and maintenance of company Quality Management System (QMS) and integrated Learning Management System (LMS) and Controlled Document System as appropriate.
• Serve as POC for  QMS related training assignments for Development colleagues

Qualifications

• Relevant qualification within healthcare or Life Sciences or equivalent professional experience
• Demonstrable experience in Quality Assurance within the life sciences industry, ideally covering all clinical phases, with demonstrable experience in a GLP/GCP quality/compliance role
• Knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS)
• Strong familiarity with eTMF requirements
• Extensive experience managing deviations, RCA and CAPAs in a GLP /GCP environment
• Experience leading quality event investigations/ root cause analysis
• A thorough understanding of global drug development functional areas including preclinical, clinical, regulatory affairs and manufacturing
• Highly collaborative, strong relationship building skills with high level of integrity.
• Demonstrated ability to work proactively using solid communication and influencing skills to effectively execute program goals
• Exhibits flexibility and is a self-starter with a strong attention to detail
• Demonstrated ability to adapt working style to those of others for effective communication; able to multi-task and support multiple teams with varying levels of complexity
• Able to work effectively in highly complex and fast-paced environments
• Strong organizational and time management skills
• Familiarity with Electronic Document Management (EDM) systems and Microsoft Office suite
• Position requires both domestic and international travel up to 10% of time

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