Senior Director, Clinical Pharmacology
Found in: beBee jobs US - 3 weeks 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 of Clinical Pharmacology will provide leadership to the Clinical Pharmacology and Pharmacometrics team and be accountable for the overall strategy for determining the PK, PD, and immunogenicity properties of all programs at Dyne Therapeutics. This person will be the company's subject matter expert (SME)and will be responsible for . This position requires an individual with experience and expertise in matrixed leadership and team management, as they will be expected to lead, develop, and educate through cross-functional teams. This individual should be able to efficiently and effectively synthesize data to produce a clinical pharmacology strategy for the programs at Dyne. . The ideal candidate will have a strong knowledge of best practices in Clinical Pharmacology and Pharmacometrics, extensive experience in designing and executing clinical pharmacology studies, and a demonstrated ability to make data-driven decisions based on preclinical and clinical information. The person will also work very closely with team members in the bioanalytical and biomarker function. As a core member of cross-functional program teams the selected candidate will work in close collaboration with colleagues in discovery, research, clinical development, clinical operations, and project management contributing to multiple IND submissions, initiation of clinical development programs, late-stage development, and interactions with health authorities.
This role is based in Waltham, MA without the possibility of being a remote role.
Primary Responsibilities Include:
Lead the Clinical Pharmacology accountability for Dyne portfolio from IND to post-approval, including design and implementation of program specific clinical pharmacology studies, data analysis, internal decision points, and external regulatory interactions.
Represent Translational Biomarkers SME providing expertise and guidance on PK/PD and clinical pharmacology on discovery and program teams.
integrate clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical development, biostats, regulatory, nonclinical and research to support and impact development decisions
Develop clinical pharmacology plans to support the development and registration of Dyne programs.
Be responsible for protocol design of clinical pharmacology trials, study planning, review, data analysis / interpretation, and reporting of individual studies implemented to support clinical pharmacology components of project plans.
Determine scope, design, and planning and analysis of pharmacokinetic (PK) and pharmacodynamic (PD) studies, and modeling/simulations required from a drug development and regulatory perspective to take a project from concept to NDA submission.
Lead and prepare appropriate documents or sections of clinical protocols, clinical study reports with respect to Clinical Pharmacology studies or data.
Author regulatory documents (IND's, NDA's, IB's, etc.) and respond to regulatory inquiries related to DMPK, PK/PD, and clinical pharmacology.
Identify and manage consultants and vendors and monitor work with external vendors to ensure compliance with agreed protocols, quality standards and timelines.
Review external data, lead analysis, interpretation, and reporting of clinical pharmacokinetic and pharmacodynamic data.
Ensure that appropriate PK, PD and PK/PD data analyses (including population PK, PK/PD modeling and simulation) are conducted for each study/program while adhering to timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs.
Collaborate cross functionally with all relevant areas to support corporate objectives.
Education and Skill Requirements:
PhD, PharmD, or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines with at least 10 years of bio/pharmaceutical industry drug development experience in Clinical Pharmacology
Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
Demonstrated track record and ability to manage the clinical pharmacology/ pharmacokinetic components of programs in clinical stage of development.
Experienced in performing Modeling and Simulation (M&S) in drug development (i.e.. PK/PD, PBPK, mechanistic modeling, population PK)
Proficient and experienced in using common PK/PD modeling software packages (i.e., Phoenix WinNonlin, NONMEM, R, SAS, and other similar tools)
Experienced in preparing Clinical Pharmacology portions of regulatory documents such as the pre-IND, IND, IB, briefing documents, clinical study reports, CTA, and BLA submission documents.
Previous experience in antibody-drug conjugates and/or oligonucleotides is desirable.
Ability to innovate dosing strategies in a data-driven manner for this novel class of molecule.
Strong interpersonal and relationship building skills with demonstrated experience to lead and influence within a matrixed environment.
Ability to work and communicate in an open and clear manner, listening effectively and inviting responses and discussions with internal and external partners.
Must be independent and highly motivated, with the ability to multi-task, driving strategy and execution, in a fast-paced collaborative environment.
#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...
-
Associate Director, Medicinal Chemistry, TTD, Early Oncology
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States AstraZeneca Full timeAssociate Director, Medicinal Chemistry, TTD, Early OncologyThis role is part of our strategy to deliver next generation of therapeutics including, but not limited to, small molecule, peptide and antibody drug conjugates to treat cancer.Close collaboration with computational chemistry, in vivo pharmacology, structure biology, and related functions will be...
-
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 - 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 - 3 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....
-
SVP, Head of Clinical Development
Found in: beBee jobs US - 3 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 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....
-
Director, Clinical Quality Assurance
Found in: beBee jobs US - 3 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....
-
Associate Director, Clinical Scientist
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 - 1 week 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....
-
Director, Regulatory Affairs
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, CMC Regulatory Affairs
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Tscanrx Full timeWe are looking for an experienced CMC professional to join our team as a Director of CMC Regulatory Affairs supporting our growing pipeline of TCR T-cell therapies.The Director of CMC Regulatory Affairs will be responsible for supporting and leading the development and implementation of US, eventually global, CMC regulatory strategies for TScan's oncology...
-
Psychiatrist / Director
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Evoke Wellness at Waltham Full timeCompany Overview At Evoke Wellness, our mission is to empower individuals on their journey to recovery from addiction and mental health challenges. We provide compassionate, evidence-based care that fosters personal growth, resilience, and lasting positive change. Through comprehensive treatment and unwavering support, we aim to help individuals rediscover...
-
Associate Director, Statistical Programming
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....
-
Associate Director, Supply Chain Planning
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....
-
Associate Director, Regulatory Operations
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...
-
Associate Director, HR Operations
Found in: beBee jobs US - 5 days 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 - 3 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...
-
Practice Manager- Waltham
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Massachusetts General Hospital(MGH) Full timeSCOPE OF POSITIONReceiving general direction from the Administrative Director and the Associate Chief of Pediatric Primary Care. This role holds first-line responsibility for the supervision of the clinical administrative team (6 FTEs currently) which includes oversight of the development of policies and procedures, data tracking and reporting, and back-up...
