Associate Director / Director, Clinical Science

Why join us?

FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon™ therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma 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.

FOG-001, the company’s first-in-class TCF-blocking β-catenin inhibitor, is being evaluated in a Phase 1/2 study for patients with advanced solid tumors, including colorectal cancer. FogPharma 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. FogPharma has raised more than $500 million to date from leading life sciences investors. FogPharma 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 Associate Director/Director, Clinical Science (CS), will be an essential scientific and clinical contributor within Clinical Development, with an emphasis on study specific activities for one or more clinical trials within FogPharma and may support the expansion of products into other trials and indications. The Associate Director/Director CS will drive the design, planning, and implementation of protocols for assigned investigational products and will play a key role in supporting related regulatory activities.  This role will work on cross-functional program development and study management teams for the design, execution, and monitoring of clinical trials, as well as assisting with the data interpretation, visualization, and communication to both internal and external stakeholders. Depending on the needs of the organization, the Associate Director/Director CS may also mentor other Clinical Scientists. 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 and collaborate closely with the Senior Director, Clinical Science.

• Integrate scientific knowledge and operational expertise to ensure translation of clinical research plans into high quality studies.
• Partner with cross-functional program and study-level teams to oversee the conduct of clinical studies, including operational feasibility, data management deliverables, preparation of meeting materials, staff training, safety and medical monitoring, preparation of status update reports, support of regulatory filings, and study close-out activities.
• Contribute significantly to the development of CRFs, edit checks, patient profiles, and data trend analysis.
• Perform medical and related safety/efficacy data reviews. May be responsible for analytical support of clinical trial data, including data gathering/visualization, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.  Analyze information to assess issues relating to protocol conduct and/or individual subject safety. Prepare and communicate a clear overview of trial results.
• Develop and maintain clinically relevant study tools including clinical trackers, and assist the medical monitor in eligibility review.
• Assist in writing clinical protocols and amendments, writing or reviewing health authority briefing books, clinical study reports, IBs, ICFs, SAPs, training documents, and other clinical and regulatory documents.
• Review and present data and information to external investigators and internal stakeholders as needed.
• Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of the development strategy and clinical trial objectives; responds to or triages questions for appropriate escalation.
• Write and/or review collaborative abstracts, posters, and content for scientific meetings, conferences, and publications. Support the publication strategy.
• Present at investigator meetings and scientific conferences.
• Maintain proficient understanding of therapeutic disease area(s) and drug candidate(s), including the underlying disease biology, therapeutic practices, compound(s) mechanism of action, and the drug landscape.
• Conduct literature reviews and summarizes findings as needed.
• Support internal process initiatives, including development of data and document standards.

What you’ll need to be successful:

• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or another scientific field preferred).
• 7-10+ years of total experience with 3-5+ years as a CS or related role in a pharmaceutical, CRO or biotechnology company.
• Phase 1/2 Oncology experience is required. Phase 2/3 Oncology experience is a plus.
• Exceptional clinical data analysis, data visualization, and data interpretation skills. Expertise in Spotfire or similar data visualization platform preferred.
• Demonstrated ability to evaluate, interpret, and present complex scientific data (preclinical, clinical, translational) to inform scientific hypotheses and development strategy.
• Knowledge of oncology response criteria, such as RECIST 1.1.
• 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).
• Creative problem-solving skills.
• Self-motivated and adaptable in a dynamic, nimble, start-up environment.
• Strong computer skills and experience using Microsoft Office applications, eTMF, and EDC platforms.
• Ability to work cross culturally and with a variety of time zones.
• Position is on-site or remote.
• Travel as needed for SIVs, conferences, and strategic onsite meetings (~10-20%).

Core Values

FogPharma 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, Fog 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.fogpharma.com