Join Us: Careers & Culture

POSITION SUMMARY

Bicara Therapeutics is seeking a Senior Accountant / Accounting Manager to join our Finance team. This individual will be a key member of the team and will also provide support and assist in many aspects of financial accounting and reporting. This is a new position that will interact with all levels of management. This is a hands-on position and the ability to multitask and work with others is essential, as well as the ability to work efficiently and effectively in a remote capacity, as needed.

KEY RESPONSIBILITIES

• Prepare annual and quarterly financial statements
• Month-end close
• Technical accounting
• Review and approve employee expense reports and maintain Expensify database
• Prepare Review mapping of invoices to the correct account
• Setup payment runs
• Prepare reconciliations for certain accounting areas such as research and development, manufacturing, clinical accrual investments and other accounting transactions as needed
• Assist with external audit and tax consultants’ requests
• Assist with investors’ financial request
• Assist in the coordination of SOX compliance documentation and testing
• Participate in special projects and ad hoc reporting as necessary

REQUIRED SKILLS

• SEC reporting
• Internal controls compliance
• Ability to search adoption of new accounting guidance
• Proven attention to detail and excellent quantitative and analytical skills
• Provide professional customer service internally and externally
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload
• A flexible attitude with respect to work assignments and new learning
• Excellent interpersonal, verbal, and written communication skills; value the importance of teamwork
• Open to change and willing to learn new accounting areas.

REQUIRED QUALIFICATIONS

• BS or BA degree in Accounting
• CPA required
• 3+ years of experience; pharmaceutical industry experience a plus
• Advanced Excel skills; very good level of proficiency in Microsoft Office
• Knowledge of Prendio, Bill.com, NetSuite or another ERP a plus

COMPANY OVERVIEW

Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics
engineered to bring together the precision of targeted therapy and the power of tumor modulators. The company’s bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, potentially offering long-lasting efficacy. Bicara’s lead asset, BCA101, a first-in-class EGFR / TGF-β-trap bifunctional antibody, is currently enrolling patients in a Phase 1/1b study. Bicara’s experienced team brings deep expertise across immunology, oncology, clinical development, business development and operational strategy. More information is
available at www.bicara.com.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

To apply, please email your resume/CV to [email protected]. In the subject line include your name and the job title.

POSITION SUMMARY

The Senior Manager of Clinical Data Management will execute data deliverables for all phases of clinical trials and programs as part of the clinical development group. This role will proactively participate within cross functional teams of internal clinical colleagues as well as external contract research organizations and other data vendors, driving end-to-end data quality and integrity from source through to submission. The Sr. Manager of Clinical Data Management will also contribute to the development of departmental documents and procedures.

KEY RESPONSIBILITIES

• Functions as internal Study Data Manager, overseeing all data management activities performed by CROs including generation and review of metric status and patient tracking reports; ensuring major DM deliverables and milestones are met.
• Assist in review of vendor proposals, budgets, scopes of work; Provides input to protocols, and other clinical study documents during development.
• Review and manage key documents such as data management plans, guidelines for CRF completion, data review, SAE reconciliation, Vendor Oversight, TMF plans, and data audits.
• Following CDISC conventions, oversee or perform eCRF design and annotation, database design specifications; Develop or oversee CRO generation of data edit check specifications (DVS); Participate in user acceptance testing (UAT) of the clinical database, including edit check testing.
• Create Bicara specifications for internal study team data review plan.
• Lead internal study team in data review; Perform data review for quality issues and general data trends; generate queries as necessary.
• Define/oversee data transfer specifications for external data sources (labs, ECGs, PK, eCOA) and transfer of data; reconcile or oversee CRO lab reconciliation with clinical database.
• Work with SAS and/or clinical systems programming to produce in-process data reports and data visualization tools to facilitate decision making on clinical trials (e.g., safety reviews). Provide input on standard tools and reports.
• Study DM liaison with cross-functional team members and external vendors to ensure completion of all timelines and study-related tasks; Ability to work independently as well as within a cross-functional team environment.
• May give Data Management presentations and/or training at investigator or other meetings.
• Participate in development and implementation of departmental initiatives. Reviews and provides input to improve data management SOPs and guidelines.
• Contribute to content development and/or testing of department standards.

MINIMUM REQUIREMENTS

• Strong understanding of end-to-end Clinical Data Management in a biotech or pharma environment
• Oncology and Ph2/3 experience preferred
• Sr. Manager level: minimum experience: 5+ years
• Experience working with DM vendors and CROs highly desirable
• Familiarity with Medidata RAVE and/or other clinical data management software preferred
• Experience executing UAT scripts for testing of electronic data capture systems including eCOA (Electronic Clinical outcome assessment) systems
• Knowledge of GCP and other regulations
• Must have excellent oral and written communication / presentation / negotiation skills
• Ability to manage multiple (changing) priorities under tight timelines
• Detail oriented, able to identify issues and consistently collaborate to solve problems in a timely manner

COMPANY OVERVIEW

Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics
engineered to bring together the precision of targeted therapy and the power of tumor modulators. The company’s bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, potentially offering long-lasting efficacy. Bicara’s lead asset, BCA101, a first-in-class EGFR / TGF-β-trap bifunctional antibody, is currently enrolling patients in a Phase 1/1b study. Bicara’s experienced team brings deep expertise across immunology, oncology, clinical development, business development and operational strategy. More information is
available at www.bicara.com.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

To apply, please email your resume/CV to [email protected]. In the subject line include your name and the job title.

POSITION SUMMARY

In this newly created leadership role, the Director of Information Technology (IT) will be a key member of the organization reporting to the President & Chief Operating Officer. They will create and manage the strategic direction for the Company’s IT operations, ensuring efficient and effective technology services throughout the organization and driving next-level maturity to enable ongoing growth and future scaling of our IT operations. To support these efforts they will partner closely with all business functional units and external managed services provider(s).

KEY RESPONSIBILITIES

• Develop and maintain the IT Operation organization’s strategic road map, ensuring IT
  capabilities, including data management and security, consistently support the organization’s goals and priorities
• Partner with business organizational teams to play a strategic role in the exploration and selection, implementation, and ongoing management of the company’s software, hardware, and technology support services.
• Responsible for overall IT process development, documentation and oversight (e.g., user, vendor and company onboarding, offboarding, end user support and emergency management).
• Develop and maintain a well-structured lifecycle management strategy of all hardware, and software assets, including effective user onboarding and offboarding.
• Provide oversight for developing, maintaining, and publishing technology standards, procedures, and guidelines.
• Oversee IT systems, policies, and processes aligned with SOX compliance including implementation and monitoring of IT general controls, segregation of duties and documentation of controls and testing.
• Own the planning, coordination, implementation, and change management related to cross-enterprise IT projects.
• Partner with the Office Manager to ensure full support for facility changes and projects.
• Create and manage the Disaster Recovery Program and IT Business Continuity plans.
• Establish and manage strong vendor relationships and oversee negotiation and administration of vendors, consultants, and service agreements.
• Lead the analysis, enhancement, and tailoring of current practices and existing systems to increase operating efficiencies and reduce costs
• Establish and maintain IT related budgets to effectively meet company financial objectives

SKILLS, QUALIFICATIONS AND EXPERIENCE

• Bachelor’s degree in Computer Science, Information Technology, Business Administration, or another related field.
• A minimum of 10 years’ experience in the IT field; experience in biotech/pharma required; experience in GxP environments a plus.
• Possess solid knowledge in emerging technologies, and the ability to apply these in the service of the company’s key business goals.
• Demonstrated ability to build and lead the IT Operations and Service Desk functions.
• Demonstrated ability to design and implement comprehensive approaches to cyber security and risk management.
• Builder of strong technology vendor partnerships, and able to manage multiple vendor relationships to ensure the best performance and financial return.
• Broad knowledge of a range of vendor technology solutions; able to select and integrate the most appropriate technologies to support the business.
• Strong leadership, communication, collaboration, negotiation, problem-solving, decision-making, and influencing skills with the ability to engage with stakeholders at all levels; lead and support projects and change initiatives of various sizes and complexities enterprise wide.
• Strong knowledge of IT financial, spend management, resource allocation management, change management, communication management, business process optimization, and continuous improvement methodologies and techniques.
• Strategic thinker with a focus on problem solving, driving innovation, and continuous improvement.
• Strong knowledge of project management methodologies, tools, and techniques; Project Management Professional (PMP) certification or equivalent preferred.

COMPANY OVERVIEW

Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics
engineered to bring together the precision of targeted therapy and the power of tumor modulators. The company’s bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, potentially offering long-lasting efficacy. Bicara’s lead asset, BCA101, a first-in-class EGFR / TGF-β-trap bifunctional antibody, is currently enrolling patients in a Phase 1/1b study. Bicara’s experienced team brings deep expertise across immunology, oncology, clinical development, business development and operational strategy. More information is
available at www.bicara.com.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

To apply, please email your resume/CV to [email protected]. In the subject line include your name and the job title.