FogPharma
Medical Director / Senior Medical Director, Clinical Development
FogPharma, Cambridge, Massachusetts, us, 02140
Medical Director / Senior Medical Director, Clinical Development
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 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 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.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 discontinuationPartner with cross-functional program and study-level teams to translate a clinical strategy into clinical trial design and protocols.Perform clinical monitoring of one or more studies.Perform medical and related safety/efficacy data reviews in partnership with the clinical scientist (CS)Help the CS develop and maintain clinically relevant study tools including clinical trackersConduct eligibility review and manage the eligibility review processWork closely with sites to address and resolve relevant clinical queriesIdentify and build relationships with investigatorsAuthor protocols and contribute to authoring of clinical study reports, IBs, ICFs, SAPs, DSURs, training documents, and other clinical and regulatory documentsInteract with internal and external stakeholders (study sites, vendors, committees, etc) in support of program-level development strategy and clinical trial objectivesAuthor and/or review collaborative abstracts, posters, and content for scientific meetings, conferences, and publications. Support the publication strategy.Interpret clinical data and make appropriate decisions and recommendationsSupport internal process initiatives, including development of data and document standardsWhat 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 for the Senior Medical Director level must have 3+ years of experience in the pharmaceutical industry or have demonstrated exceptional accomplishments otherwisePhase 1/2 Oncology clinical development experience preferredPossess a deep understanding of the fundamentals of protocol development and clinical trial designProven team leadership capabilities, especially in a matrix environmentDemonstrated ability to evaluate, interpret, and present complex scientific data (preclinical, clinical, translational) to inform scientific hypotheses and development strategyWorking knowledge of biostatistics, GCP, and regulatory requirements for clinical studiesSolid attention to detail and excellent organizational skills, while understanding higher-level strategyStrong 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 organizationAbility to establish priorities, excellent sense of urgency and a strong desire to collaborateCreative problem-solving skillsSelf-motivated and adaptable in a dynamic, nimble, start-up environmentAbility to work on-site or remotely and attend in-person meetingsAbility to work cross culturally and with a variety of time zonesTravel as needed for SIVs, conferences, and strategic onsite meetings (~20-25%)Core ValuesFogPharma 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.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.
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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 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 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.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 discontinuationPartner with cross-functional program and study-level teams to translate a clinical strategy into clinical trial design and protocols.Perform clinical monitoring of one or more studies.Perform medical and related safety/efficacy data reviews in partnership with the clinical scientist (CS)Help the CS develop and maintain clinically relevant study tools including clinical trackersConduct eligibility review and manage the eligibility review processWork closely with sites to address and resolve relevant clinical queriesIdentify and build relationships with investigatorsAuthor protocols and contribute to authoring of clinical study reports, IBs, ICFs, SAPs, DSURs, training documents, and other clinical and regulatory documentsInteract with internal and external stakeholders (study sites, vendors, committees, etc) in support of program-level development strategy and clinical trial objectivesAuthor and/or review collaborative abstracts, posters, and content for scientific meetings, conferences, and publications. Support the publication strategy.Interpret clinical data and make appropriate decisions and recommendationsSupport internal process initiatives, including development of data and document standardsWhat 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 for the Senior Medical Director level must have 3+ years of experience in the pharmaceutical industry or have demonstrated exceptional accomplishments otherwisePhase 1/2 Oncology clinical development experience preferredPossess a deep understanding of the fundamentals of protocol development and clinical trial designProven team leadership capabilities, especially in a matrix environmentDemonstrated ability to evaluate, interpret, and present complex scientific data (preclinical, clinical, translational) to inform scientific hypotheses and development strategyWorking knowledge of biostatistics, GCP, and regulatory requirements for clinical studiesSolid attention to detail and excellent organizational skills, while understanding higher-level strategyStrong 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 organizationAbility to establish priorities, excellent sense of urgency and a strong desire to collaborateCreative problem-solving skillsSelf-motivated and adaptable in a dynamic, nimble, start-up environmentAbility to work on-site or remotely and attend in-person meetingsAbility to work cross culturally and with a variety of time zonesTravel as needed for SIVs, conferences, and strategic onsite meetings (~20-25%)Core ValuesFogPharma 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.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.
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