Senior Director, Translational Biomarkers
Found in: beBee jobs US - 1 week ago
Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).
Role Summary:
The Senior Director, Translational Biomarkers supports the development of Dyne's translational strategy for programs currently in late research/early development working collaboratively with cross functional team members. This role is responsible for designing and execution of preclinical and clinical development plans in terms of endpoints and biomarkers with a focus on quick win/fail early strategies and early proof of concept. This individual also builds strategies to establish surrogates to enable later stage development. This position works collaboratively across therapeutic areas and research teams to ensure planning, execution, and delivery of the strategy for clinical trials conducted by Dyne.
This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.
Primary Responsibilities Include:
Develop a biomarker strategy to support clinical development for early-stage clinical programs
Lead the clinical prioritization of biomarkers for early clinical development programs for early proof-of-concept and late-stage clinical development
Develop and provide input and recommendations into all study related documentation (including protocol, informed consent form, and amendments) and processes
Assist in the selection of clinical diagnostic biomarkers and explore new technologies through collaboration and partnerships, internal and external
Evaluate technologies to identify, define and implement clinical biomarker strategies to support the clinical development of Dyne's programs
Author the biomarker sections of Investigator Brochures, Clinical Study Protocols and Reports, program documents, regulatory submissions and responses (INDs/CTAs) as well as co-author, assist and support the development of publications, abstracts, and presentations
Partner with biostatisticians and computational experts to ensure delivery and interpretation of high-quality data to support internal decision-making and health authority filings
Partner closely with cross-functional experts in Research, Non-Clinical/Pre-Clinical, Clinical Development, Biostatistics, Bioinformatics, Regulatory, and external partners
Education and Skills Requirements:
M.D. or Ph.D. required with at least 15 years of experience in the pharmaceutical/biotechnology industry or equivalent government/academic experience
Experience with rare disease development or related science focus is required
Experience designing and building clinical development plans preferred
Thorough understanding of rare muscle diseases, with experience integrating novel endpoints and biomarkers into clinical trials
Must be familiar with scientific methods including assays (binding and cell based), flow cytometry, transcriptomics, sequencing, and diagnostic assays
Experience in clinical translational or biomarker work and its role across drug development from early phase through licensure
Solid experience in the application of biomarkers during development of assets is preferred, including experience with clinical translational research
#LI-Onsite
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
-
Senior Living Sales Director
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Benchmark Senior Living Full timeJob Description Waltham Crossings, a Benchmark Senior Living community, is looking for a Sales Director Joining the Benchmark Senior Living team means putting your passion to work. Our associates feel a sense of belonging with the care that they provide, empowered by the open and reliable team that surrounds them. Our diverse and skilled workforce takes...
-
Senior Director, Clinical Pharmacology
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
-
Executive Director, Medical Director
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
-
Senior Director, FP
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Ventus Therapeutics Full timeVentus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop medicines...
-
Senior Director, Drug Safety and Pharmacovigilance
Found in: beBee jobs US - 1 week ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
-
Senior Director of Revenue Operations
Found in: beBee jobs US - 6 days ago
Waltham, Massachusetts, United States Allego Full timeThe Senior Director of Revenue Operations at Allego is responsible for ensuring the smooth and efficient functioning of the Sales and Marketing teams through effective processes, tools, and analytics. This role involves leadership, coordination, and management of various support functions including reporting, budgeting, forecasting, and systems development....
-
Senior Scientist, Bioanalysis
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
-
Director of Product Portfolio
Found in: beBee jobs US - 1 week ago
Waltham, Massachusetts, United States REVVITY Full timeJob TitleDirector of Product Portfolio - Signals Workflows (REMOTE)Location(s)US Remote - DC, US Remote - DE, US Remote - FL, US Remote - GA, US Remote - ID, US Remote - IL, US Remote - IN, US Remote - KY, US Remote - MA, US Remote - MD, US Remote - ME, US Remote - MI, US Remote - MN, US Remote - NC, US Remote - NH, US Remote - OH, US Remote - OR, US Remote...
-
Director, Regulatory Affairs
Found in: beBee jobs US - 1 week ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
-
Senior Program Manager
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Boston Engineering Full timeCompany DescriptionBoston Engineering improves the way people work and live through innovative product design and novel engineering. We are product designers and engineers for the Medical, Industrial, Commercial, and Defense sectors. Experts in robotics, motion control and embedded systems, DFX, and digital transformation, we are ISO 9001 and ISO 13485...
-
Director, Clinical Quality Assurance
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
-
HR Program Manager, Diversity
Found in: beBee jobs US - 1 week ago
Waltham, Massachusetts, United States Thermo Fisher Scientific Full timeJob DescriptionDiversity and Inclusion Program ManagerWe are seeking a passionate and experienced Diversity and Inclusion Program Manager to join the Culture and Counsel platform within the HR team at Thermo Fisher Scientific. As a Diversity and Inclusion Program Manager, you will play a vital role in supporting and implementing programs defined by our...
-
SVP, Head of Clinical Development
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
-
VP, Head of Compliance
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
-
Senior Director, Translational Biomarkers
Found in: beBee S US - 2 weeks ago
Waltham, United States Dyne Therapeutics Full timeCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...
-
Principal Investigator, Translational Science
Found in: Appcast US C2 - 1 week ago
Waltham, United States Ventus Therapeutics Full timeAbout us:Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop...
-
Director of Translational Medicine
Found in: Resume Library US A2 - 2 weeks ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob Description We are seeking an experienced, highly-motivated and engaged Director of Translational Medicine. The successful candidate will have extensive experience as a Translational Medicine lead for clinical trials ranging from Phase 1 through Phase 3. This person will have an understanding of clinical development and experience developing...
-
Senior Living Sales Director
Found in: beBee S US - 2 weeks ago
Waltham, United States Benchmark Senior Living Full timeJob Description Waltham Crossings, a Benchmark Senior Living community, is looking for a Sales Director! Joining the Benchmark Senior Living team means putting your passion to work. Our associates feel a sense of belonging with the care that they provide, empowered by the open and reliable team that surrounds them. Our diverse and skilled workforce takes...
-
Senior Director, Clinical Pharmacology
Found in: beBee S US - 2 weeks ago
Waltham, United States Dyne Therapeutics Full timeCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...
-
Data Science Communities, Associate Director
Found in: Jooble US O C2 - 2 weeks ago
Waltham, MA, United States Taleo BE Full timeAssociate Director, Oncology Data Science Join our Early Data Science team in the Oncology R&D department at AstraZeneca, where we are growing to meet the strategic challenges pursued by AZ Oncology. We are looking for a talented and highly motivated Associate Director of Data Science to join a team designing and applying cutting-edge computational...
-
Senior Director, Drug Safety and Pharmacovigilance
Found in: Jooble US O C2 - 2 weeks ago
Waltham, MA, United States Dyne Tx Full timeSenior Director, Drug Safety and Pharmacovigilance With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed toovercome limitations in delivery to muscle tissue.Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonicdystrophy type 1 (DM1) and Duchenne muscular...
-
Executive Director, Medical Director
Found in: beBee S US - 7 days ago
Waltham, United States Dyne Therapeutics Full timeCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...
-
Waltham, United States Taylor Strategy Partners Full timeDescription Sr. Director, GMP Quality Assurance, Commercial Position Summary: The Senior Director Quality Assurance will provide expertise and guidance on Good Manufacturing Practice for all commercial products. They will adhere to applicable regulations and work with stakeholders to proactively identify compliance issues and risks and implement corrective...
-
Senior Director, GMP Quality Assurance, Commercial
12 hours ago
Waltham, United States Taylor Strategy Partners Full timeDescription Sr. Director, GMP Quality Assurance, Commercial Position Summary: The Senior Director Quality Assurance will provide expertise and guidance on Good Manufacturing Practice for all commercial products. They will adhere to applicable regulations and work with stakeholders to proactively identify compliance issues and risks and implement corrective...
-
Senior Director, GMP Quality Assurance, Commercial
Found in: Jooble US O C2 - 2 weeks ago
Waltham, MA, United States Taylor Strategy Partners Full timeDirector, GMP Quality Assurance, Commercial The Senior Director Quality Assurance will provide expertise and guidance on Good Manufacturing Practice for all commercial products. They will adhere to applicable regulations and work with stakeholders to proactively identify compliance issues and risks and implement corrective actions, risk mitigation. They...
-
Waltham, United States Benchmark Senior Living Full timeJoining the Benchmark Senior Living team means putting your passion to work. We invite you to connect with your calling, find purpose in your career, and gain lifelong relationships through the power of human connection by transforming the lives of seniors! The Director of Health and Infection Prevention Control partners with Resident Care, Quality, Risk...
-
Senior Director, Drug Safety and Pharmacovigilance
Found in: beBee S US - 2 weeks ago
Waltham, United States Dyne Therapeutics Full timeCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...
-
Director of Health and Infection Prevention Control
Found in: Appcast US C2 - 1 week ago
Waltham, United States Benchmark Senior Living Full timeJoining the Benchmark Senior Living team means putting your passion to work. We invite you to connect with your calling, find purpose in your career, and gain lifelong relationships through the power of human connection by transforming the lives of seniors! The Director of Health and Infection Prevention Control partners with Resident Care, Quality, Risk...
-
Senior Director, Process Development
1 week ago
Waltham, United States HireMinds Full timeSenior Director, Process Development Waltham, MA We're seeking a highly motivated and talented Senior Director to lead our drug substance process development and manufacturing team. The successful candidate will play a key role in overseeing internal process development, technology transfer, and external manufacturing to support the development portfolio....
-
Senior Director, Drug Safety and Pharmacovigilance
Found in: Jooble US O C2 - 2 weeks ago
Waltham, MA, United States Dyne Tx Full timeOur commitment to people with muscle diseases is our greatest strength Senior Director, Drug Safety and Pharmacovigilance Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.With its proprietary FORCE platform, Dyne is developing...
-
Executive Director, Medical Director
Found in: Jooble US O C2 - 2 weeks ago
Waltham, MA, United States Dyne Tx Full timeOur commitment to people with muscle diseases Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed toovercome limitations in...
-
Internal Sales Director
1 week ago
Waltham, United States Maplewood at Weston Full timeCommunity Relations Director Generous base salary and commission plus comprehensive benefits package! Want to know what makes our employees eager about going to work every day? The people we serve. Being apart of Maplewood requires passion and a desire to help others. Each employee has the ability to touch the hearts of all our seniors and be a part of...
-
Senior Director, GMP Quality Assurance, Commercial
Found in: Jooble US O C2 - 2 weeks ago
Waltham, MA, United States Taylor Strategy Partners Full timeDescription Sr. Director, GMP Quality Assurance, Commercial Position Summary: The Senior Director Quality Assurance will provide expertise and guidance on Good Manufacturing Practice for all commercial products. They will adhere to applicable regulations and work with stakeholders to proactively identify compliance issues and risks and implement...
-
Senior Director, FP
Found in: beBee S US - 7 days ago
Waltham, United States Ventus Therapeutics Full timeVentus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop medicines...
