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Director/Senior Director, Clinical Operations

Boston, Massachusetts, United States

Bitterroot Bio, Inc. is a Series A biotech company focusing on cardio-immunology, investigating the interplay between the immune system and cardiovascular health. By understanding the intricate mechanisms by which these cells contribute to disease, we are developing innovative immunotherapies that target the root causes of cardiovascular disease rather than just treating its symptoms.

For us to be successful we are single-minded on hiring talented people who are eager to engage, are naturally curious, who want to be part of providing a new hope to those suffering from cardiovascular diseases. We are looking at transforming the way these diseases are treated. You have an opportunity to put your hand on and shape a company as it moves into phase 2, and its next round of funding.

About you:

We are looking for a highly collaborative, motivated, and experienced clinical operations leader to drive Bitterroot’s lead program forward. This role offers the opportunity to make a meaningful impact by applying scientific, operational, and leadership expertise to become an integral part of the Bitterroot Bio team. Reporting to the VP of Clinical Development Operations, you will be responsible for advancing the lead clinical trial, supporting key company initiatives, shaping clinical strategy, and enabling timely, high-impact decisions.

You will work closely with the Clinical Operations and Clinical Development teams who are highly experienced and deeply engaged professionals who prioritize collaboration, purpose-driven work, and making a real difference for those affected by cardiovascular disease and atherosclerosis.

In this role, you will:

  • Provide operational and implementation expertise to Clinical trial team(s) to enable the timely progression of clinical development programs;
  • Drive the selection process of clinical trial external resourcing, including generation of Request for Proposal; perform and document Sponsor-level oversight and management of vendors (or collaboration partner) for outsourced activities;
  • Work with the cross-functional project team to identify and evaluate issues in the clinical program and suggest and implement solutions;
  • Contribute to design, development and review of clinical documents including, but not limited to protocols, investigator brochures, trial reports and other trial related documents;
  • Provide oversight for the development of trial-specific documents (e.g., informed consent forms, study plans/guidelines, operation manuals & training materials);
  • Contribute to and assist with the development of the clinical components of regulatory submissions;
  • Maintain oversight and participation in creation/review/training/maintenance of departmental and organization SOPs to ensure compliance;
  • Analyze and develop action plans to address protocol compliance, safety, data, and administrative issues with investigational sites;
  • Oversee and manage Clinical Operations program budget;
  • Evaluate CRO, site and study performance metrics against agreed upon trial budget, deliverables, and timelines;
  • Ensure that goals and objectives for clinical development programs(s) is met by providing strategic and tactical input by developing program specific goals, managing timelines, tracking metrics, producing, and presenting summary metrics/reports;
  • Prepare and present clinical trial updates to project teams and management and review any potential issues or recommendations;
  • Lead and mentor junior Clinical Operations team members;
  • Partner closely with Program Leadership to shape and execute on the clinical trial strategy, goals and plans and ensure alignment within the Program Team and across all expertise areas; 
  • Drive coordination of cross-functional activities and promote effective communications (e.g., Team meetings, program updates); integration of people involved within the clinical team (e.g., clarity of responsibilities).
  • Provide guidance to teams and line function members in negotiating challenges and driving to key decisions and milestones for clinical trials;
  • Ensure team adherence to ICH/ GCP/ Federal and local regulations and company specific processes;
  • Contribute to and/or lead diverse initiatives to improve Bitterroot’s enterprise-wide operations, planning, and execution, as needed;
  • Establish effective communication channels to provide visibility into prioritization and progress on projects as well as ad-hoc updates;
  • Lead other key initiatives as they arise in a fast-paced, startup environment with the ability to embrace change, innovate, and initiate process improvements across the organization. 

As our ideal candidate you have:

  • BS/MS in a life sciences or related degree with 7+ years’ experience in a pharmaceutical or biotechnology environment, including 5+ years’ experience managing a team(s).
  • Documented success in achieving goals and deliverables in clinical activities.
  • Knowledge of drug discovery, research, and development processes with ability to impact clinical strategy and operations.
  • Strong leadership skills; demonstrated ability to work well in a collaborative, and dynamic team environment, set priorities, and drive results.
  • Experience developing strong, effective relationships with key stakeholders.
  • Ability to present information and strategies in a clear and concise business fashion, identifying key issues and concerns and recommending corrective actions.
  • Excellent verbal and written communication and organizational skills required with demonstrated success in leading trials and interacting with cross-functional teams.
  • Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced, and evolving environment.

Beyond our Science

We live our principles: Visionaries and unsinkable; Hungry for impact and having a heart; Embracing risk and excellence; Demanding the bitter truth. We understand the power of collaboration, curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions, in this we have a single-minded determination to achieve together. We want to change the paradigm on how cardiovascular is addressed and treated.

Bitterroot Bio provides a competitive compensation package, including a base salary, bonus, stock options, a 401(k) with company match, unlimited paid time off, cellphone reimbursement, and more!

Recruitment Process

The anticipated salary range for candidates in Needham, Massachusetts is $215,000 to $270,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc.

Bitterroot Bio is committed to fair and equitable compensation practices. While our ranges are posted, the exact base pay offered for this role will depend on various factors, including but not limited to the successful candidate's qualifications, skills, experience, location or comparison to other employees already in similar roles. In addition to base salary, our positions are eligible for variable compensation through one of our incentive plans as well as equity compensation based on role and level. 

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