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 Medical Director/Senior Medical Director, 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 strategy and execution of one or more programs within FogPharma. This person will also work with key functions for the expansion of products into other trials and indications, if applicable, 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 program development and study management 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.
- Responsible for clinical development activities from site initiation to study discontinuation
- Partner with cross-functional program and study-level teams to translate a clinical strategy into clinical trial design and protocols. This includes helping to lead the authoring of important documents from the clinical perspective such as the protocol and protocol amendments, along with the clinical scientist and medical writing, and overseeing the conduct of clinical studies.
- Perform clinical monitoring of one or more studies.
- Perform medical and related safety/efficacy data reviews in partnership with the clinical scientist (CS), including data cleaning support as appropriate
- Help the CS develop and maintain clinically relevant study tools including clinical trackers
- Conduct eligibility review and manage the eligibility review process
- Work closely with sites to address and resolve relevant clinical queries
- Identify and build relationships with investigators
- Author protocols and contribute to authoring of clinical study reports, IBs, ICFs, SAPs, DSURs, training documents, and other clinical and regulatory documents
- Interact with internal and external stakeholders (study sites, vendors, committees, etc) in support of program-level development strategy and clinical trial objectives; responds to or triages questions for appropriate escalation
- Author 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 as appropriate
- Interpret clinical data and makes appropriate decisions and recommendations
- Support internal process initiatives, including development of data and document standards
What you’ll need to be successful:
- MD or MD, PhD degree in health related field, with a deep understanding of clinical oncology. US Board Certified in Hematology or Oncology preferred.
- Candidates for the Medical Director level must have completed fellowship in a subspecialty medical training, hematology/oncology fellowship preferred, and have some experience with clinical trial research at a minimum. Candidates with at least some experience in the pharmaceutical industry are preferred
- Candidates for the Senior Medical Director level must have 3+ years of experience in the pharmaceutical industry or have demonstrated exceptional accomplishments otherwise
- Phase 1/2 Oncology clinical development experience preferred
- 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)
- 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
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
