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The position involves collaboration with protein science, in-vivo biology, single-cell sequencing, bioinformatics, translational and clinical teams to execute and advance HiFiBiO's drug discovery and translational research.
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The individual will be responsible for TM and clinical biomarker activities to support drug development programs in neurodegeneration and neuropsychiatric indications. Experience in late stage drug development and activities required for and related to clinical trial initiation, maintenance and completion.
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You will play a critical role in shaping the company's brand perception and driving the launch of an innovative drug to an underserved rare disease community. As the Director of Patient Marketing at ITF Therapeutics, you will be responsible for developing and implementing strategic initiatives that align with the brand strategy to engage and collaborate with the individuals, caregivers, and families of those living with Duchenne muscular dystrophy, a rare, genetic, neuromuscular disease.
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Provides ad-hoc programming support to Clinical Operations, Data Management, Statistical Programming, Biostatistics, Drug Safety, Clinical Science, Medical Writing and Drug Safety to ensure rapid access to clinical study data for data cleaning/validation, SAS listings review, TLF, dry runs, etc.
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Experience in immuno-oncology drug development is a must. Advanced scientific degree (MD, PhD, DVM, PharmD), with a minimum of 12 years of relevant work experience developing translational medicine strategies, developing and testing hypotheses in the clinic, biomarker identification and development, biomarker data interpretation.
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Ability to communicate on topics of basic science is essential; a working knowledge of global drug development including preclinical & clinical is required. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development.
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The Principal Scientist of Analytical Development and QC at Foghorn Therapeutics will drive the analytical development and QC functions, ensuring the successful advancement of small molecule candidates from preclinical through NDA for both drug substances and drug products.
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This key leadership role will require an individual to direct and oversee in vitro pharmacology efforts, participating in drug discovery and early development activities. With a highly experienced drug development team and access to the wide ecosystem of Flagship companies, Pioneering Medicines is well positioned to conceive new medicine ideas both internally and in collaboration with strategic partners and advance these assets through to significant value inflection.
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Excellent working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. The Senior Director of Clinical Development will lead and oversee clinical development programs from early-stage trials through to regulatory approval, ensuring alignment with the company’s strategic objectives.
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Provides input into the Translational Medicine Plan that defines the biomarker strategy and other aspects to increase the knowledge about the pathway and effects of the drug. The Clinical Research Director (CRD), Amlitelimab, Immunology and Inflammation Therapeutic Area is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to the Clinical Lead in charge of the clinical strategy.
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The Sr. Product Director, Pipeline Management Lead works across multiple, complex product initiatives across our innovative drug development suite. The Sr. Product Director, Pipeline Management Lead works across multiple, complex product initiatives across our innovative drug development suite.
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Minimum of 10 years experience in drug development, clinical research and operational strategy experience including responsibility ensuring studies and programs are executed to quality, timelines and budget (at least part of this time in a Biotech/Pharma environment is preferred.
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Strong understanding of the drug development process including strategic and operational aspects from preclinical through lifecycle management. Director/Senior Director, Program Management Company Overview Repertoire Immune Medicines is a biotechnology company working to unlock and direct the remarkable power of the human immune system to treat cancer, autoimmune disease and infectious disease.
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The CDxL pushes the boundaries of seamless Dx strategy and implementation to select the right patient at the right time, to fulfill regulatory commitment and enable commercial success, thus optimizing access to the right drug, with a patient-centric perspective; Based on this vision, the CDxL is responsible for implementing CDx strategies throughout precision drug development, from early clinical stages to on-market support & life cycle management.
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The Director, External Manufacturing, will report to the VP, Commercial Manufacturing & Supply Chain, and is accountable for the business, relationship and operational management of all activities performed within Viridian's Contract Manufacturing Organization (CMO) network (includes biologics Drug Substance and Drug Product manufacturing, device component production, combination device assembly and commercial finished goods production.
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drug job Title: director in Waltham, MA
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