Inflammation Research Association Announces
Interactive Job Board Focused on Immunology and Inflammation Opportuniies


Blade Therapeutics – Vice President Regulatory Affairs

Location: San Francisco, CA

COMPANY BACKGROUND

Blade Therapeutics is advancing novel anti-fibrotic therapies to meet important patient needs in an area that has seen little innovation to date. Several rare/orphan and chronic debilitating conditions manifest as a consequence of fibrosis, a complex, pathologic process in which progressive scarring replaces functional tissue. We are seeking to develop therapies to modify disease progression, and in some cases, potentially reverse the fibrotic damage to tissue.

Blade is advancing a risk-diversified product portfolio to address various fibrotic diseases and their underlying pathophysiology. The Company has assembled a critical mass of fibrosis expertise and a top-tier leadership team and world-class network of advisors with unparalleled experience in anti- fibrotic drug R&D. Blade’s founding programs are based on the discoveries of Hal Dietz, M.D., Victor A. McKusick Professor of Genetics and Medicine, Johns Hopkins University, whose pioneering research has elucidated a biological pathway that is enabling the discovery of small molecules to treat and potentially reverse fibrosis.

Blade’s objective is to be the leading anti-fibrotic company with a pipeline of novel therapies designed to address the unmet needs for innovative treatments to treat various fibrotic conditions.

ROLE: VICE PRESIDENT REGULATORY AFFAIRS

The VP of Regulatory Affairs develops and implements regulatory and related strategies to gain regulatory approval in the US and global markets for the development and commercialization of BLADE Therapeutics’ products. Ensures adequate planning and accurate regulatory submissions for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements.

KEY RESPONSIBILITIES

  • Strategic management and communication of regulatory strategy to internal and external stakeholders (FDA, EMEA, and TGA).
  • Coordinates and ensures internal/external resources are appropriate to ensure quality and timeliness of global regulatory submissions.
  • Assists in the selection and early development of programs by developing regulatory strategies and identifying regulatory risks.
  • Responsible for ensuring Regulatory Affairs has resources (staffing and facilities) to maintain documentation and forecasts future staffing requirements.
  • Ensures internal and/or external resources are adequate to provide Regulatory Affairs support for company projects. Interacts with senior level regulatory personnel at external partner companies, contract manufacturers and regulatory agencies.
  • Ensures resources are identified to support short- and long-term corporate goals and communicates impacts to Project Management/Managers and senior management.
  • Evaluates industry organizations and governmental agency initiatives and prepares company responses.
  • Resolves significant conflicts and disputes within and/or across departments. Negotiates win/win scenarios for organizational productivity and efficiency.
  • Reviews and manages overall departmental activities, ensuring alignment with company project timelines.
  • Manages departmental budget to plan, communicating major deviations and impacts to senior management.
  • Forecasts the most efficient use of internal and external staffing resources to ensure appropriate program/project regulatory support.
  • Provides input to R&D department activities, including but not limited to; Regulatory Affairs staffing requirements, budget proposal and tracking, regulatory SOPs, training requirements, improvements in operational efficiencies, etc.
  • Provides regulatory opinion and guidance reflecting Regulatory Affairs department practice/philosophy/policy to executive management.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

  • Strategic thinker with ability to drive regulatory vision and communicate it to board and senior team.
  • Comfortable leading and building a small team.
  • History of success at developing and managing electronic investigational new drug applications with FDA (CDER); focus in hepatology, pulmonary, and cardiovascular therapeutic areas a plus.
  • History of successful completion of special protocol assessments, orphan drug designations, and fast track designation processes.
  • Experience with new drug applications [505(b)(1) and 505(b)(2)] and drug master files and demonstrated success at managing processes with EMEA.
  • Demonstrated experience and ability to successfully interact and negotiate with senior FDA/EMA/International Regulatory Agency reviewers on IND/CTA issues including but not limited to Pre-IND, FDA Types A-C, End of Phase II, and Pre-NDA Meetings with CDER.
  • Superior managerial skills including management of global teams and external vendors/partners.
  • Experienced at developing regulatory department policies and procedures including the establishment of SOPs, templates, databases, and electronic publishing systems.
  • Excellent leadership and organizational skills, written and verbal communication skills, and interpersonal skills are required; must be able to effectively use these skills to influence many diverse internal and external customer groups at various levels within organizations.
  • Must be experienced in staff and organizational development, motivating personnel/teams, and providing effective coaching, training and development.
  • Must be detailed oriented, self-driven and goal-oriented, and able to multi-task to achieve results.
  • Must be able to adhere to strict project time-lines and budgets, and to helm and advise teams and management of impacts and changes in project time-lines.
  • Ability to manage changing priorities, evaluate impact, and communicate time-line and resource impacts to project teams and management is required.
  • Up to 15% travel may be required.

EDUCATION

  • Advanced degree and a minimum of 10 years of regulatory experience

COMPENSATION

An attractive compensation package commensurate with this senior leadership role will be provided.

Please contact Marianne Eid, Human Resources at meid@blademed.com.


Pfizer – Postdoctoral Fellow, Inflammation and Immunology – Focus on Interaction of the Microbiome in Inflammatory Bowel Disease

Location: Cambridge, MA

ROLE SUMMARY
The microbiome has emerged as a key contributor to autoimmune and inflammatory disorders, including the pathogenesis of Inflammatory Bowel Diseases (IBD). The Epithelial Biology and Systems Immunology Groups within Pfizer’s Inflammation and Immunology Research Unit are actively examining host-microbiome interactions in IBD. We are seeking a highly motivated, talented, and creative postdoctoral candidate with a strong background in microbiology, molecular biology, microbial immunology or a related field, and familiarity with bioinformatic and/or statistical methods to investigate the role of host-microbiome interactions in health and disease in preclinical IBD models. The candidate will be responsible for running in vivo studies to examine how perturbations to the microbiome and host immune system affect disease outcomes, and use novel computational approaches to analyze and integrate multi-type omics datasets.

ROLE RESPONSIBILITIES

  • Collaborate closely with experimental and computational scientists to explore fundamental research questions with an emphasis on novel discoveries that will result in high impact publications.
  • Participate in design of targeted in vivo interventions to address key questions about the role of the microbiome in treatment efficacy and disease outcomes in preclinical IBD models.
  • Study the host and microbiome dynamics by applying discovery-based computational approaches to multi-type omics data.
  • Develop and utilize cell-based systems to functionally validate in vivo observations.
  • Organize, interpret, and analyze data, and identify areas where key knowledge is lacking.
  • Effectively communicate data and results at internal and external meetings/conferences.

BASIC QUALIFICATIONS

  • Recent Ph.D. in biology, microbiology, molecular biology, cell biology, or a related field.
  • Experience running in vivo disease models, including harvesting, processing, and analyzing tissue.
  • Experience with bacterial and mammalian cell/tissue culture and related techniques, including ELISA, qPCR, western blot, and/or fluorescence microscopy.
  • Excellent communication and organizational skills, and willingness to learn new skills.
  • Demonstrated research productivity by first-author publications in peer-reviewed journals.

PREFERRED QUALIFICATIONS

  • Familiarity with computational tools for analyzing genetic and genomic data.
  • Experience culturing aerobic and anaerobic bacteria, and running bacterial infection models in the gastrointestinal system.

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   Pfizer is an E-Verify employer.

Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Apply
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Pfizer – Postdoctoral Fellow, Inflammation and Immunology – Target Discovery for Rheumatoid Arthritis With a Focus on Synovial Fibroblasts

Location: Cambridge, MA

ROLE SUMMARY
At Pfizer, we strive to improve the life of patients through innovative therapy. Our work in the discovery group within the Inflammation & Immunology research unit is to build the foundation of tomorrow’s medicine by deciphering disease pathways in autoimmunity to identify novel therapeutic targets.

We are looking for a highly motivated scientist to join our group as a postdoctoral fellow. Your research will focus on identifying and characterizing the role of synovial fibroblast subsets in rheumatoid arthritis. Deepening our understanding of the protective and pathogenic roles of synovial fibroblasts will be crucial for the establishment of novel therapeutics that would be complementary to current therapies focused on modulating the inflammatory response.

In this project, you will have the opportunity to learn and apply cutting edge technology such as RNAseq, FACS sorting, multicolor histology and analysis of complex datasets. Moreover, the emerging importance of synovial fibroblast in RA pathogenesis will strategically position you as a new biology leader in the autoimmunity field while also giving you critical industry experience.

ROLE RESPONSIBILITIES

  • Computational analysis of complex datasets
  • Isolate specific cell population by flow cytometry to characterize them in vitro
  • Establish model systems to decipher interactions of synovial fibroblasts with innate immune cell types
  • Validate findings in murine models of arthritis
  • Present findings at internal and external conferences, and publish results in high impact peer-reviewed journals

BASIC QUALIFICATIONS

  • Recent PhD in immunology, bioinformatics or related field (0-4 years)
  • Strong track record of scientific publications
  • Hands-on experience with basic immunological techniques, including cell culture, cell isolation, multi-color flow cytometry, immunohistochemistry
  • Basic programming skills or understanding of systems immunology
  • Ability to work efficiently in a team
  • Excellent oral and written communication skills

PREFERRED QUALIFICATIONS

  • Molecular and computational expertise
  • Hands-on experience in murine model of arthritis

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Apply
Apply with LinkedIn


Homology Medicines – Director, Discovery Research – Immunology

Location: Bedford, MA

The Director , Discovery Research will work in a project team environment. Internally, she or he will interface directly with multiple functional areas including preclinical research, bioinformatics and molecular genomics, target biology, and vector production. In addition, the successful candidate will be a hands-on scientist, actively driving projects in the laboratory. Externally, she or he will also liaison to external alliance partners, CROs, vendors, academics, and others.

Essential Functions and Duties:

  • Play active hands-on role in investigating the host immune response to our novel AAVHSC vectors (Elispot, neutralizing antibody assays, etc) employing a variety of modern molecular/cell biology techniques
  • Develop and implement in vitro cell culture assays to assess AAVHSC-mediated
  • Manage external project communications in order to provide up-to-date project information and documentation to the team.
  • Company representative for management of programs at external CROs, academic centers, and research partners.

Experience:

  • PhD preferred, training in immunology is essential, background in viral gene therapy and AAV is preferred.
  • Hands on experience in wide variety of molecular techniques including FACS, Elispot, ddPCR, qPCR techniques, tissue culture etc.

Contact:

John Rynak
Senior Staffing Consultant
Homology Medicines
617-645-1345
jrynak@homologymedicines.com


Janssen Research & Development, L.L.C., a division of Johnson & Johnson’s Family of Companies is recruiting for an Associate Director, located in Spring House, PA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The primary responsibility for this position is to provide scientific leadership within the Immunopharmacology team and to interface with the Biology teams for the discovery of novel therapeutics for autoimmune diseases. Responsibilities will include shaping and influencing overall in vivo strategies in collaboration with discovery teams, leading a team of biologists in prosecuting project strategies and delivering high quality preclinical data packages to enable project progression. The Associate Director will also coach, mentor and manage people for performance and scientific growth. Additional responsibilities include but are not limited to:

  • Leads the analyses of highly complex scientific issues, establishes strategies and suggests actionable resolutions/decisions in a given program/project
  • Identifies novel scenarios and nascent scientific /technical opportunities
  • Track record of leading/managing complex research programs by effectively interfacing with various functional teams with in discovery and preclinical development (eg., Lead discovery, Formulations, DMPK, Preclinical Safety and Toxicology, Clinical Pharmacology and Early Clinical Development) to advance drug candidates from concept to clinic.
  • Designs and executes experimental plans, provides interpretation, troubleshoots and suggest next steps
  • PhD in Immunology/Pharmacology with at least 10 years of pharmaceutical industry experience with progressively advanced responsibilities is required; Post-doctoral training is preferred
  • Experience leading/ advancing drug discovery programs in immune-mediated diseases is required
  • A record of accomplishments evidenced by publications/patents is required
  • Solid background in Immunology/ Pharmacology is required
  • Broad understanding of autoimmune disease pathophysiology and mechanistic in vivo modeling is required
  • Preclinical modeling of autoimmune disease is preferred
  • Proven drug hunting experience and advancing projects from concept to clinic is required