Senior Project Manager, Clinical Operations

Posted 10 Days Ago
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Boston, MA, USA
Hybrid
176K-206K Annually
Senior level
Software • Biotech • Pharmaceutical
The Role
Lead cross-functional clinical operations project management: develop integrated project plans, track milestones, manage budgets/invoices/accruals, coordinate CROs and vendors, support risk assessment and audits, contribute to study documentation and senior leadership updates while fostering team alignment.
Summary Generated by Built In
Position Overview

Bicara Therapeutics is seeking a Senior Project Manager to provide project management expertise and strong operational support and leadership to the team. The role is highly cross-functional with key interactions with internal and external stakeholders. In partnership with the Clinical Operations Team, the Project Manager will assist in developing integrated plans and will understand developing strategy, identifying critical path activities and determining risks / mitigation plans.

The successful candidate will have strong communication skills. They will be highly organized, detail oriented, comfortable with ambiguity, and have a proven track record of managing and driving projects. The role will report to the Senior Director, Clinical Operations.

This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

Responsibilities
  • Serve as an integral part of the Clinical Operations core team to drive operations efficiently including generating integrated project plans, identifying and tracking key project milestones and metrics, and monitoring budgets, invoices, and accruals.

  • Provide cross-functional transparency of the clinical trial(s) progress to ensure team is efficiently progressing forward with deliverables, including deliverables from CRO and other partners.

  • Organize internal and external meetings (development of agendas, minutes, and presentations).

  • Manage ancillary supplies for clinical trials.

  • Support risk management including risk assessment, mitigation planning, and internal and external audit preparation and follow-up.

  • Contribute to development of clinical study plans and manuals, including version tracking and team training.

  • Provide support to senior leadership in defining the deliverables on the clinical trial(s) which coincide with the expectations defined in the departmental and company goals.

  • Maintain ongoing communication with team members and all stakeholders including senior leadership and external partners or vendors.

  • Foster a sense of inclusion and create a shared sense of purpose.

Qualifications
  • Bachelor’s degree in life sciences or a related field required.

  • A minimum of 5+ years of industry experience with a minimum of 3+ years of project management in the biotech/pharmaceutical industry. Preference for experience in oncology clinical trials with solid knowledge of ICH/GCP and related guidelines and regulations.

  • Strong experience in project management techniques and principles including, but not limited to, project planning, execution and tracking, and risk identification and management.

  • Strong organizational and leadership skills, including demonstrated ability to maintain a high level of productivity and influence at all levels of an organization.

  • Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.

  • Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates and issues to senior leadership and to all levels of the organization, as needed.

  • Ability to work independently and successfully in a fast-paced, results-driven, highly accountable environment with large potential impact; ability to prioritize and manage multiple tasks simultaneously, integrate cross-functional issues, and balance competing priorities effectively.

  • Willingness to travel up to 10-15% of the time.

Company Overview

Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. For more information, please visit 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.

Skills Required

  • Bachelor's degree in life sciences or related field
  • Minimum 5+ years industry experience with at least 3+ years project management in biotech/pharmaceutical industry
  • Knowledge of ICH/GCP and related guidelines and regulations
  • Strong experience in project management techniques: planning, execution, tracking, risk identification and management
  • Experience managing clinical trial budgets, invoices, and accruals
  • Strong organizational, leadership, analytical, problem solving and critical thinking skills
  • Excellent oral and written communication, presentation and facilitation skills
  • Ability to work independently in a fast-paced, results-driven environment and manage multiple priorities
  • Willingness to travel up to 10-15% of the time
  • Preference for experience in oncology clinical trials
  • Based in Boston office, hybrid schedule with three in-office days per week
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