Senior Director, Clinical Operations

 

About Parabilis Medicines 

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable. The company has pioneered a new class of alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that have historically been beyond the reach of conventional medicines. The company’s lead investigational medicine, zolucatetide, is the first and only direct inhibitor of the β-catenin:TCF interaction, a central node in the Wnt/β-catenin pathway that has eluded drug developers for decades. Zolucatetide is being evaluated in the clinic across multiple Wnt/β-catenin-driven diseases, including desmoid tumors, familial adenomatous polyposis (FAP) and a range of other solid tumor indications. Beyond zolucatetide, Parabilis is advancing additional Helicon-based programs focused on other challenging targets where we believe our medicines could have life-altering impact. For more information, visit www.parabilismed.com or follow us on LinkedIn. 

What’s the opportunity?

The Senior Director, Clinical Operations will provide strategic and operational leadership across multiple clinical trials or a full clinical program, ensuring trials are conducted in accordance with protocols, SOPs, GCP, and departmental and corporate goals. This role sets clinical operations strategy for their assigned program(s) or indications, leads and develops a team of clinical operations professionals (which may include Clinical Trial Associates, Clinical Trial Managers and Clinical Operation Leads (Associate Director and Directors), and provides senior-level leadership and input to ensure GCP compliant delivery of cross functional activities. This individual will collaborate closely with the Senior Director Operational Excellence to ensure clear direction to CROs and other vendors. In addition, the role will collaborate with the Senior Director of Site Management & Monitoring as well as Senior Director Site Engagement and Advocacy. This leader will also represent Clinical Operations in cross-functional governance forums and contribute to the evolution of corporate SOPs and department-wide initiatives.

You will work in a nimble, dynamic, matrix environment with investigative site staff, and a variety of vendors and consultants to ensure trial delivery in accordance with SOPs, applicable regulations, and guidelines. This individual will report directly to the Senior Vice President, Clinical Operations.

Responsibilities

• Accountable for delivery of assigned clinical program(s)/trials (or indications) - budget, timelines, resourcing, and quality - including developing operational strategy, clinical operations plans, and risk assessment/mitigation in support of the Clinical Development Plan
• Lead and oversee execution of all trial phases based on stage of development, in compliance with ICH/GCP, local regulations, and Parabilis procedures
• Provide senior-level leadership and oversight to the cross-functional team and CRO/vendor(s), including evaluation, qualification, onboarding, and training of vendors and investigative sites
• Represent the Clinical Operations function in discussion with potential partners or collaborative studies.
• Represent the Clinical Operations function in any regulatory inspection along with the assigned Study or Indication Leaders.
• Provide senior clinical operations input into regulatory documents such as clinical trial protocols, informed consent forms (ICFs), investigator brochures, and study reports
• Ensure study- and program-level Sponsor Oversight of outsourced clinical activities and lead inspection readiness activities with the ability to withstand audits and regulatory inspections
• Communicate program status, cost, risk, and issues to senior management to enable timely decision-making
• Provide significant input on the creation, review, training, and maintenance of departmental and organizational SOPs, and lead clinical operations workstreams tied to departmental and operating model initiatives
• Provide managerial oversight, mentorship, and career development for assigned clinical operations staff, including performance management, talent development, succession planning,
• Drive trial and site level performance and engagement through clear expectation setting and remediation planning; develop and maintain strong relationships with investigators, site staff, collaborators, and Key Opinion Leaders
• Own program/trial budget management, reporting, and forecasting, and ensure resourcing/prioritization of assigned programs aligns with portfolio strategy
• Represent Clinical Operations in cross-functional and senior leadership governance forums, and maintain current knowledge of the external environment to ensure innovations (such as AI/Machine Learning) are incorporated into clinical trial delivery strategy

What you’ll need to be successful:

• S./B.A. in life science or related field; advanced degree preferred
• 12+ years of clinical operations experience in biotechnology, pharmaceutical, and/or CRO industry, including prior people leadership experience
• Phase 1-3 global trial management experience, including first-in-human studies, preferably in Oncology or complex GI malignancies and inherited genetic conditions such as Familial Adenomatous Polyposis (FAP)
• Direct experience overseeing global CROs in both fully and partially outsourced models
• Direct line management experience, including managing managers/senior individual contributors, with proven ability to set operational strategy and guide multiple study teams to achieve program goals and timelines
• Ability to lead complex or multiple programs and exercise sound judgment and critical thinking with minimal supervision, and to motivate, inspire, and develop teams
• Strong interpersonal and communication skills (written and oral), including experience communicating with senior leadership, plus solid attention to detail and organizational skills
• Self-motivated and adaptable in a dynamic, nimble, start-up environment, with a strong sense of urgency, creative problem-solving skills, and willingness to fill functional gaps in a small but growing organization
• Strong computer skills and experience using Microsoft Office applications, CTMS, eTMF, IRT, and EDC platforms; demonstrated use of AI tools in your current role is required, and advanced or innovative use of AI is a strong plus
• Ability to work on-site or remotely and attend in-person meetings
• Willingness to travel (up to 30%)
• Demonstrated use of AI tools in your current role and responsibilities is required advanced or innovated use of AI is a strong plus.
• Previous demonstration of Health Authority interactions, interviews and inspections

Core Values

Parabilis Medicines is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.

• Growth-Minded. We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.
• In(ter)dependent. We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
• Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
• All-In. We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.

The base salary range for this position is $255,000-$290,000 per year, depending on experience, qualifications, and internal practices. Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees’ overall well-being.

As an equal opportunity employer, Parabilis Medicines values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

30 Acorn Park Drive    |     Cambridge, MA 02140    |    www.parabilismed.com