Senior Medical Director/Associate Vice President, Clinical Development - Parabilis Medicines

Why join us?

Parabilis Medicines is a highly distinctive young biopharmaceutical company whose intention is to grow over time into the ranks of major therapeutics companies.  Our foundational platform of Helicon™ therapeutics are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, Parabilis is poised to revolutionize the medical possibilities for patients by precisely drugging intracellular targets long understood to be significant drivers of disease but never before drugged due to the limitations of existing drug modalities to act within the cell.

An important distinctive element of Parabilis is our lead program FOG-001, the company's first-in-class TCF-blocking β-catenin inhibitor.  This compound is approximately 18 months and ~50 patients into our early development program for patients with advanced solid tumors, most importantly colorectal cancer. There are few products in the ecosystem with the medical and economic potential of FOG-001. Parabilis is fully leveraging the unprecedented potential Helicons present by deploying proprietary, custom-built machine learning and computational methods as part of its discovery and development process. Parabilis Medicines has raised more than $500 million to date from leading life sciences investors. Parabilis Medicines is headquartered in Cambridge, Mass.

What's the opportunity?

In this role, you will help us develop a new drug modality for cancer and other diseases with unmet medical needs by working directly with Research and Development (R&D) functions to execute clinical trials.

The Senior Medical Director or Associate Vice President, Clinical Development, will be responsible for providing strategic leadership for the clinical/medical aspects of clinical drug development, with an emphasis on program-specific medical monitoring, protocol development, and the clinical development plan (CDP) strategy and execution of one or more programs within Parabilis. The position will initially focus on building and executing the CDP for FOG-001, the lead program for the company. This includes leading the Clinical Development Team (CDT) and driving clinical development strategy for this program as well as representing Clinical in the Global Program Team (GPT) .

You will also work with key functions for the expansion of FOG-001 into other trials and indications, and potentially lay the groundwork for other programs as they enter the clinic. This role will drive the design, planning, and implementation of protocols for assigned investigational products and will play a key role in leading related regulatory activities.  This role will help to lead cross-functional clinical teams for the design, execution, and monitoring of clinical trials, as well as lead the analysis of study results, including clinical data interpretation, visualization, and communication to both internal and external stakeholders. This person may also help support internal process improvement initiatives within clinical development.

You will work in a nimble, dynamic, matrix environment with Clinical Trial Teams (CTT), 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 Vice President, Head of Clinical Development and FOG-001 Program Development Team Leader.

Importantly, this person must have both the technical expertise to function as an individual contributor, when needed, and possess the leadership qualities required to help successfully build and lead cross-functional teams. 

These qualities should consist of the following:

Strategic Leadership:

• Develop and implement comprehensive clinical development strategies for the company's lead program, FOG-001, aligning with corporate objectives and evolving landscape

Clinical Trial Design & Execution:

• Lead the design, initiation, and management of clinical trials across all phases (Phase I-IV), including patient recruitment, data collection, and analysis.

Medical Expertise:

• Provide medical and scientific leadership on FOG-001, ensuring compliance with regulatory requirements and industry best practices.
• Identify best practices and look for creative solutions for complex problems.

Cross-Functional Collaboration:

• Work closely with teams regulatory, biometrics and data management, clinical operations, commercial, medical affairs, and other departments to ensure seamless execution of clinical development plans

Budget Management:

• Oversee clinical development budgets in close collaboration with clinical operations, and cost management for clinical trials.
• Make recommendations for resourcing as required for the appropriate operationalization of studies

 Regulatory Submissions:

• Contribute significantly to the preparation of clinical study reports, Investigator Brochures, and regulatory submissions to support global drug approval

 External Stakeholder Management:

• Build and maintain relationships with key external stakeholders such as investigators, thought leaders, clinical trial sites, CROs, and regulatory agencies

What you'll need to be successful:

• MD or MD/PhD in health-related field, with a deep understanding of clinical oncology. US Board Certified in Hematology/Oncology preferred.
• 8+ years of experience in the pharmaceutical industry or have demonstrated exceptional accomplishments otherwise
• Phase 1/2 Oncology clinical development experience required, with additional late development experience preferred
• Global development experience desired
• Possess a deep understanding of the fundamentals of protocol development and clinical trial design
• Proven team leadership capabilities, especially in a matrix environment, and history of strong interactions with thought leaders
• Demonstrated ability to evaluate, interpret, and present complex scientific data (preclinical, clinical, translational) to inform scientific hypotheses and development strategy
• Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
• Solid attention to detail and excellent organizational skills, while understanding higher-level strategy. Ability to handle multiple projects at the same time
• Strong interpersonal and communication skills (both written and oral)
• Supportive team member with a willingness and ability to fill functional gaps in a small but growing organization
• Ability to establish priorities, excellent sense of urgency and a strong desire to collaborate (self-aware, effective relationship management and interpersonal skills)
• Pioneering mindset with creative problem-solving skills
• Self-motivated and adaptable in a dynamic, nimble, start-up environment
• Ability to work on-site or remotely and attend in-person meetings
• Ability to work cross culturally and with a variety of time zones
• Travel as needed for SIVs, conferences, and strategic onsite meetings (~20-25%) 

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.

• Creative. We are creating a whole new class of medicine requiring creativity to solve challenges as they arise, which we have successfully done since the inception of the company.
• 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.
• Execution-oriented. As we begin clinical development and large-scale manufacturing, the team is balancing creativity and nimbleness with relentless, rigorous and flawless execution.
• Humble. We fully appreciate that science and technology and policy are in flux, and we balance deep experience with humility to ask fundamental questions and seek newly available solutions.

As an equal opportunity employer, Parabilis Medicines values diversity 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