VP, Head of Compliance
Found in: beBee jobs US - 2 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:
In this role, the Head of Compliance will design, implement, and administer a comprehensive compliance program appropriate to the size and stage of Dyne that is scalable as Dyne transitions to a commercial stage company. The Head of Compliance also will act as the primary resource for healthcare law legal counseling across the entire organization. The person in this role will work with our CEO and Board of Directors
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:
Strategic compliance advisor to the Board of Directors and the management team
Healthcare law and data privacy legal advisor to the entire company
Responsible for the compliance program with respect to data privacy/protection, anti-bribery, and corporate compliance.
Senior member of the Legal & Compliance team, a highly visible representative for the team
Design, implement and maintain an effective global healthcare compliance program encompassing compliance with healthcare laws and ethical codes
Engage employees, management and Board with the compliance agenda, its strategic importance to the business and its relationship to our values and goals;
Design, implement, administer, and continuously improve an effective global healthcare compliance program, including policies and procedures, compliance committees, training, communication, monitor and auditing, enforcement, and investigations
Design, implement, and maintain system to check for excluded individuals/entities;
Review and advise on publications, promotional / pre-promotional materials, presentations, and agreements concerning dealings with Healthcare Professionals (HCPs), patients, patient advocacy groups, payors, and reporting.
Responsible for the compliance program with respect to data privacy/protection, anti-bribery, and corporate compliance in partnership with other subject matter experts and functional leads
Responsible for implementing and conducting price and transparency reporting
Responsible for providing legal advice to the organization on pre-commercial and commercial healthcare law issues as well as data privacy issues
Responsible for managing any external resources that may be required, ensuring company receives high-quality advice on time and on budget
Stay connected across the business in a monitoring role to identify and proactively address compliance issues
Support the Head of Legal in compliance and healthcare law matters as well as administrative matters
Grow and mature the Compliance function and the Healthcare legal function
Education and Skills Requirements:
JD from accredited law school and license to practice in at least one US jurisdiction; compliance certification preferred
Minimum of 15 years of experience in healthcare compliance and healthcare law, preferably with experience in a clinical-stage biotechnology company and a top-tier law firm
Comprehensive knowledge of and experience in all US compliance topics
Experience with compliance regimes outside of the US in major ex-US markets
Experience with data privacy (g., GDPR, state privacy laws)
Experience in an in-house role
Experience interacting with a management team and/or a Board of Directors
Experience in the design and implementation of a healthcare compliance program for a growing biotechnology company
Proven self-starter and multi-tasker in a fast-paced environment
Excellent communication, writing and computer skills
Ability to collaborate well with internal and external stakeholders
Excellent analytical, organizational and information-seeking skills; detail oriented
Exceptional business judgment, with the ability to think strategically and give practical advice while balancing business needs with legal risks
#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.
-
SVP, Head of Data Analytics
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....
-
SVP, Head of Data Analytics
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....
-
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....
-
VP, Global Market Access
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....
-
Assistant City Solicitor
Found in: beBee jobs US - 3 days ago
Waltham, Massachusetts, United States City of Waltham Full timeThe city of Waltham is seeking qualified applicants for the position of Assistant City Solicitor to join its Law Department to provide legal counsel, representation, advocacy, prosecution, defense and litigation services. Under the general supervision of the City Solicitor, this position will require defending the city in state and federal courts and will...
-
Associate Director, Statistical Programming
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....
-
Program Lead
Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Bank of America Full timeJob Description:At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. Responsible Growth is how we run our company and how we deliver for our clients, teammates, communities and shareholders every day.One of the keys to driving Responsible Growth is being a great place to work for our...
-
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....
-
VP, Head of Compliance
4 days ago
Waltham, United States Dyne Therapeutics Inc 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...
-
VP, Head of Compliance
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...
-
VP, Head of Compliance
Found in: Jooble US O C2 - 3 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...
-
Counsel, Legal
Found in: Jooble US O C2 - 3 weeks ago
Waltham, MA, United States dynaTrace software GmbH Full timeDynatrace is looking for an experienced corporate and compliance lawyer to join its global Legal team in a newly created role. Reporting into the VP, Legal – Corporate and ESG, you will help support general corporate legal and public company matters and other projects within the Dynatrace Legal Team and also provide in-depth counsel and legal advice on a...
-
SVP, Head of Clinical Development
Found in: beBee S US - 3 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...
-
SVP, Head of Data Analytics
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...
-
Medical Device Quality
Found in: Appcast Linkedin GBL C2 - 7 days ago
Waltham, United States Client of Nachman BioMedical Full timeGreat QA/RA Project Management opportunity with a well-established and growing developer of a range of specialized medical temperature sensing devices for clinical and consumer settings. The experienced and successful QA/RA Project Manager in this new role will report to the VP of QA/RA and work with a cross functional team to assure all aspects of a new...
-
Medical Device Quality
Found in: Appcast US C2 - 1 week ago
Waltham, United States Client of Nachman BioMedical Full timeGreat QA/RA Project Management opportunity with a well-established and growing developer of a range of specialized medical temperature sensing devices for clinical and consumer settings. The experienced and successful QA/RA Project Manager in this new role will report to the VP of QA/RA and work with a cross functional team to assure all aspects of a new...
-
Medical Device Quality
7 days ago
Waltham, United States Client of Nachman BioMedical Full timeGreat QA/RA Project Management opportunity with a well-established and growing developer of a range of specialized medical temperature sensing devices for clinical and consumer settings. The experienced and successful QA/RA Project Manager in this new role will report to the VP of QA/RA and work with a cross functional team to assure all aspects of a new...
-
SVP, Head of Clinical Development
2 days ago
Waltham, United States BioSpace Full timeJob DetailsCompany 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...
-
Senior Director, Head of Market Expansion
Found in: Resume Library US A2 - 1 day ago
Waltham, Massachusetts, United States ServiceNow Full timeJob Description Reports to: VP Emerging Workflows and Market Expansion (M&A) What you get to do in this job: Develop and own the sales point of view on where ServiceNow should target inorganic growth Develop a framework for exploring options for growth (franchise, partnerships, acquisitions, co-created solutions) Assess opportunities in concert with...
-
VP, Global Market Access
Found in: beBee S US - 3 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...
-
Quality System Supervisor
2 weeks ago
Waltham, United States BostonGene Full timePosition Summary BostonGene is seeking a Quality Systems Supervisor to join our QA team. This role will integrate and manage quality assurance activities across all business units, which includes pre-analytical, analytical, and post-analytical groups under Laboratory Operations. Responsibilities ? Ensure all activities are conducted in compliance with...
-
Quality System Supervisor
Found in: Appcast US C2 - 2 weeks ago
Waltham, United States BostonGene Full timePosition SummaryBostonGene is seeking a Quality Systems Supervisor to join our QA team. This role will integrate and manage quality assurance activities across all business units, which includes pre-analytical, analytical, and post-analytical groups under Laboratory Operations.Responsibilities● Ensure all activities are conducted in compliance with...
-
Quality System Supervisor
Found in: Appcast Linkedin GBL C2 - 3 weeks ago
Waltham, United States BostonGene Full timePosition SummaryBostonGene is seeking a Quality Systems Supervisor to join our QA team. This role will integrate and manage quality assurance activities across all business units, which includes pre-analytical, analytical, and post-analytical groups under Laboratory Operations.Responsibilities● Ensure all activities are conducted in compliance with...
-
Quality System Supervisor
2 weeks ago
Waltham, United States BostonGene Full timePosition SummaryBostonGene is seeking a Quality Systems Supervisor to join our QA team. This role will integrate and manage quality assurance activities across all business units, which includes pre-analytical, analytical, and post-analytical groups under Laboratory Operations.Responsibilities● Ensure all activities are conducted in compliance with...
-
Human Resources Manager
2 days ago
Waltham, United States Ophthalmic Consultants Of Boston Full timeUnder the general direction of the VP, HR, the Human Resources Manager is responsible a broad range of administrative functions with primary focus on support for staff in the areas of onboarding, training and development, performance management, employee engagement and employee relations. The HR Manager actively partners with the HR team and Ophthalmic...
-
Human Resources Manager
1 week ago
Waltham, United States Ophthalmic Consultants Of Boston Full timeUnder the general direction of the VP, HR, the Human Resources Manager is responsible a broad range of administrative functions with primary focus on support for staff in the areas of onboarding, training and development, performance management, employee engagement and employee relations. The HR Manager actively partners with the HR team and Ophthalmic...
-
Human Resources Manager
3 weeks ago
Waltham, United States Ophthalmic Consultants of Boston Full timeJob DescriptionJob DescriptionUnder the general direction of the VP, HR, the Human Resources Manager is responsible a broad range of administrative functions with primary focus on support for staff in the areas of onboarding, training and development, performance management, employee engagement and employee relations. The HR Manager actively partners with...
-
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...
