Immunome, Inc.
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.
Position Overview The Senior Manager, Medical Writing will be responsible for directly authoring and/or leading the creation of high-quality medical and scientific documents that support the development, regulatory approval, and commercialization for one or more of our products. The role will require close collaboration with internal groups, such Clinical Operations, Clinical Development, Regulatory Affairs, Biometrics, and other stakeholders, to ensure high-quality and on-time deliverables that meet regulatory standards. Candidates should possess strong medical writing and scientific communications experience, with a strong understanding of early and late-stage drug development processes. This position reports to the Head of Medical Writing.
Responsibilities Regulatory and Clinical Documents
Author and/or manage the preparation of medical writing deliverables such as clinical study protocols, CSRs, IBs, eCTD written/tabular summaries, clinical overviews, briefing packages, Module 2 summaries, and IND enabling documents.
Develop submission strategies in collaboration with stakeholders and ensure document preparation, review, and approval follow prescribed processes and conform with appropriate regulatory guidance (i.e., GCP, ICH guidelines, and eCTD requirements).
Ensure timely and successful responses to health authority questions and/or requests.
Authoring of ICF and other patient facing materials
In collaboration with stakeholders, facilitate the redaction of clinical study protocols and other documents that fall within the scope of the implementation of EU-CTR.
Publications
Author and/or manage the preparation of manuscripts, abstracts, and posters for medical and scientific conferences and journals.
Collaborate with subject matter experts and external authors to develop high-quality publications.
Ensure publications align with strategic communication plans and company objectives.
Process Development
In collaboration with internal partners, develop and implement suitable document templates, style standards, and quality control checklists to ensure consistent and high-quality deliverables.
Ensure the development and maintenance of relevant SOPs and internal best practices.
Innovation and Digital Solutions
In collaboration with the Head of Medical Writing, evaluate and drive adoption of innovative approaches medical writing and communication strategies that may assist in document development, review, and/or QC.
Qualifications
Advanced degree (PhD, PharmD, MD) in a scientific discipline or related field preferred. Other relevant experience will also be considered.
A minimum of 6 years of experience in medical writing and scientific communications within the pharmaceutical or biotechnology industry; oncology experience a plus.
Knowledge and Skills
Knowledge of regulatory requirements and guidelines (e.g., ICH, GCP, FDA, EMA, AMA style guide).
Excellent writing, editing, and verbal communication skills.
Strong project management skills with the ability to manage multiple projects simultaneously.
Proficiency with medical writing software and tools.
Exceptional attention to detail and a commitment to excellence.
Strong business acumen and a deep knowledge and understanding of the drug development process.
Experience managing vendors and contractors a plus.
Strategic thinker with strong analytical skills and ability to work in a fast-paced environment.
Collaborative and able to build effective working relationships across the organization and with external stakeholders and collaborators.
Strong ethical standards and integrity.
Washington State Pay Range $168,934 - $202,671 USD
E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Interested in building your career at Immunome, Inc.? Get future opportunities sent straight to your email.
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Position Overview The Senior Manager, Medical Writing will be responsible for directly authoring and/or leading the creation of high-quality medical and scientific documents that support the development, regulatory approval, and commercialization for one or more of our products. The role will require close collaboration with internal groups, such Clinical Operations, Clinical Development, Regulatory Affairs, Biometrics, and other stakeholders, to ensure high-quality and on-time deliverables that meet regulatory standards. Candidates should possess strong medical writing and scientific communications experience, with a strong understanding of early and late-stage drug development processes. This position reports to the Head of Medical Writing.
Responsibilities Regulatory and Clinical Documents
Author and/or manage the preparation of medical writing deliverables such as clinical study protocols, CSRs, IBs, eCTD written/tabular summaries, clinical overviews, briefing packages, Module 2 summaries, and IND enabling documents.
Develop submission strategies in collaboration with stakeholders and ensure document preparation, review, and approval follow prescribed processes and conform with appropriate regulatory guidance (i.e., GCP, ICH guidelines, and eCTD requirements).
Ensure timely and successful responses to health authority questions and/or requests.
Authoring of ICF and other patient facing materials
In collaboration with stakeholders, facilitate the redaction of clinical study protocols and other documents that fall within the scope of the implementation of EU-CTR.
Publications
Author and/or manage the preparation of manuscripts, abstracts, and posters for medical and scientific conferences and journals.
Collaborate with subject matter experts and external authors to develop high-quality publications.
Ensure publications align with strategic communication plans and company objectives.
Process Development
In collaboration with internal partners, develop and implement suitable document templates, style standards, and quality control checklists to ensure consistent and high-quality deliverables.
Ensure the development and maintenance of relevant SOPs and internal best practices.
Innovation and Digital Solutions
In collaboration with the Head of Medical Writing, evaluate and drive adoption of innovative approaches medical writing and communication strategies that may assist in document development, review, and/or QC.
Qualifications
Advanced degree (PhD, PharmD, MD) in a scientific discipline or related field preferred. Other relevant experience will also be considered.
A minimum of 6 years of experience in medical writing and scientific communications within the pharmaceutical or biotechnology industry; oncology experience a plus.
Knowledge and Skills
Knowledge of regulatory requirements and guidelines (e.g., ICH, GCP, FDA, EMA, AMA style guide).
Excellent writing, editing, and verbal communication skills.
Strong project management skills with the ability to manage multiple projects simultaneously.
Proficiency with medical writing software and tools.
Exceptional attention to detail and a commitment to excellence.
Strong business acumen and a deep knowledge and understanding of the drug development process.
Experience managing vendors and contractors a plus.
Strategic thinker with strong analytical skills and ability to work in a fast-paced environment.
Collaborative and able to build effective working relationships across the organization and with external stakeholders and collaborators.
Strong ethical standards and integrity.
Washington State Pay Range $168,934 - $202,671 USD
E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Interested in building your career at Immunome, Inc.? Get future opportunities sent straight to your email.
#J-18808-Ljbffr