Executive Director, Regulatory Science
2 days ago
We are seeking an experienced Executive Director in Regulatory Science to lead our Regulatory CMC group and provide strategic leadership to support multiple gene therapy programs. As a senior member of our team, you will be responsible for developing innovative CMC regulatory strategies and preparing high-quality CMC sections of INDs and CTAs.
Key Responsibilities- Develop and manage the Regulatory CMC group, ensuring effective collaboration with regulatory team members, CMC and Quality teams, contract manufacturing organizations, and external experts.
- Lead the development of CMC regulatory strategies for all Tessera development programs, anticipating phase-appropriate and future commercial requirements.
- Communicate CMC regulatory program strategies with functional heads and executive team members, ensuring alignment and buy-in.
- Lead discussions with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally to refine CMC development strategies.
- Oversee planning, preparation, and submission of high-quality regulatory CMC dossiers, requiring a good understanding of the underlying science.
- Provide regulatory CMC guidance to internal teams and lead cross-functional teams to prepare briefing packages, Module 3 and 2.3 sections for INDs and equivalent IMPD sections for CTAs.
- Assess the regulatory impact of proposed manufacturing process changes and track regulatory CMC commitments.
- Manage on-going regulatory submissions and future reporting requirements, including annual reports.
- Effectively build, maintain, and motivate a high-performing regulatory CMC team, including hiring, developing, coaching, and mentoring a diverse, talented, and driven staff.
- Maintain knowledge of the global regulatory CMC environment and applicable regulations and guidelines, leading reg-CMC intelligence activities.
- Support Quality and CMC teams during GMP inspections.
You are an experienced Executive Director in Regulatory Science with specialized experience in Chemistry Manufacturing and Controls (CMC) for biologics. You are excited about being responsible for the development and management of the Regulatory CMC group and providing regulatory CMC strategic leadership to support multiple gene therapy programs, both in the US and internationally.
As a senior member of our team, you will be responsible for leading the development of innovative CMC regulatory strategies and the preparation and submission of high-quality CMC sections of INDs and CTAs, in close collaboration with regulatory team members, our in-house CMC and Quality teams, contract manufacturing organizations, external experts, and global health authorities.
At Tessera, you will find a highly collaborative, matrixed environment defined by rapid scientific innovation and a mission-driven culture dedicated to transforming the lives of patients with devastating genetic diseases.
You will make our mission possible by implementing state-of-the-art approaches to achieve operational excellence, optimize clinical trial efficiency, and accelerate the development of our gene therapies.
Tessera leaders are empathetic and transparent coaches with a strong sense of integrity. They are committed to the growth and development of their teams, the organization, and themselves.
-
Somerville, Massachusetts, United States TBWA\Chiat\Day Full timeAbout the RoleWe are seeking a visionary leader to join our team as Executive Director/Vice President, Program Leadership. As a key member of our Leadership Team, you will be responsible for establishing vision and strategy to lead two Program teams developing genome editing therapies for rare diseases.Key ResponsibilitiesEstablish and execute strategic...
-
Director of Biostatistics
3 weeks ago
Somerville, Massachusetts, United States Bristol-Myers Squibb Full timeAbout the RoleBristol Myers Squibb is seeking a highly skilled and experienced Director of Biostatistics to join our team. As a key member of our clinical development team, you will be responsible for leading the development of statistical analysis plans, designing and implementing studies, and providing statistical support for regulatory submissions.Key...
-
Regulatory Affairs Specialist
2 weeks ago
Somerville, Massachusetts, United States VCLS Full timeUnlock Your Potential as a Regulatory ScientistVCLS is a dynamic team dedicated to providing exceptional support for our clients' regulatory needs. As a Regulatory Scientist, you will play a crucial role in shaping the future of life-changing therapies.Key Responsibilities:Develop and implement regulatory strategies for the development of new drugs and/or...
-
Corporate Sustainability Director
2 days ago
Somerville, Massachusetts, United States Tbwa ChiatDay Inc Full timeJoin Our Team as a Corporate Sustainability DirectorWe are seeking a highly motivated and experienced Corporate Sustainability Director to lead our company's sustainability initiatives and drive innovative strategies that promote environmental stewardship and corporate responsibility.This role is ideal for a collaborative leader with a proven track record of...
-
Somerville, Massachusetts, United States Bristol-Myers Squibb Full timeJob SummaryBristol Myers Squibb is seeking an experienced Associate Director, Drug Development Project Manager to join our team. As a key member of our Early Development Project Management organization, you will be responsible for leading cross-functional teams and driving the execution of drug development programs.Key ResponsibilitiesLead cross-functional...
-
Director of Performance Central Reporting
3 weeks ago
Somerville, Massachusetts, United States Bristol-Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled Director of Performance Central Reporting to join our team.About the RoleThis is a unique opportunity to work with our innovative pipeline, developing and delivering...
-
Corporate Sustainability Director
2 weeks ago
Somerville, Massachusetts, United States Triumvirate Environmental Full timeCorporate Director of SustainabilityTriumvirate Environmental, a leading environmental services firm in North America, is seeking a Corporate Director of Sustainability to drive innovative strategies and initiatives that promote our commitment to environmental stewardship and corporate responsibility.This highly motivated, data-driven individual will be...
-
Director of Human Resources
2 weeks ago
Somerville, Massachusetts, United States Greentown Labs Full timeAbout Greentown LabsGreentown Labs is a leading nonprofit organization accelerating climatetech innovation and commercialization. As the largest climatetech startup incubator in North America, we empower entrepreneurs and enable collaboration to drive climate action. Our mission-driven team is dedicated to creating a sustainable future, and we're seeking a...
-
Director of Software Engineering
2 days ago
Somerville, Massachusetts, United States Motorola Solutions Full timeJob Title: Director of Software EngineeringAt Motorola Solutions, we're driven by a shared purpose - to help people be their best in the moments that matter. As a Director of Software Engineering, you'll play a critical role in shaping our software development strategy and leading a team of talented engineers to deliver innovative...
-
Somerville, Massachusetts, United States Triumvirate Environmental Full timeJob Title: Director of Environmental Health and Safety OperationsWe are seeking a highly motivated and customer-focused individual to join our Corporate EHS Compliance team as a Director of Environmental Health and Safety Operations.Job Summary:The Director of Environmental Health and Safety Operations will be responsible for developing, implementing, and...
-
Somerville, Massachusetts, United States Triumvirate Environmental Full timeJob Title: Director of Environmental Health and Safety OperationsWe are seeking a highly motivated and customer-focused individual to join our Corporate EHS Compliance team as a Director of Environmental Health and Safety Operations.Job Summary:The Director of Environmental Health and Safety Operations will be responsible for developing, implementing, and...
-
Somerville, Massachusetts, United States Bristol-Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol-Myers Squibb is a leading pharmaceutical company dedicated to discovering and developing innovative treatments for patients with serious diseases. We are seeking a highly skilled and motivated individual to join our team as an Associate Director, Quantitative Systems Pharmacology.About the RoleThis is an...
-
Senior Nursing Director
3 weeks ago
Somerville, Massachusetts, United States Mass General Brigham Full timeJob Title: Senior Nursing DirectorMass General Brigham is seeking a highly skilled and experienced Senior Nursing Director to lead our nursing team in Somerville, Massachusetts.About the Role:Lead the nursing team in providing high-quality patient care and services.Develop and implement nursing policies and procedures to ensure compliance with regulatory...
-
Director of Environmental, Health, Safety
4 weeks ago
Somerville, Massachusetts, United States Triumvirate Environmental Full timeJob Title: Director of Environmental, Health, Safety & Transportation OperationsWe are seeking a highly motivated and customer-focused individual to lead our Corporate EHS Compliance team as the Director of Environmental, Health, Safety & Transportation Operations.Key Responsibilities:Develop and implement EHS&T strategies, policies, and programs tailored to...
-
Cybersecurity Director
3 weeks ago
Somerville, Massachusetts, United States RadNet Full timeJob SummaryThe Director of Cybersecurity Operations plays a critical role in ensuring the protection of RadNet's critical assets and developing comprehensive Cybersecurity strategies. This role integrates security trust principles into organizational operations through the enforcement of SOX IT Controls and Standards. The Director of Cybersecurity Operations...
-
Somerville, Massachusetts, United States Triumvirate Environmental Full timeJob Title: Director of Environmental Health and Safety OperationsTriumvirate Environmental, a leading environmental services firm in North America, is seeking a Director of Environmental Health and Safety Operations to join our Corporate EHS Compliance team.Job Summary:We are looking for a highly motivated and customer-focused individual to develop,...
-
Senior Nursing Director
4 weeks ago
Somerville, Massachusetts, United States Mass General Brigham Full timeSenior Nursing Director Opportunity at Mass General BrighamMass General Brigham is seeking a highly skilled and experienced Senior Nursing Director to lead our Perioperative and Procedural Care Units. As a key member of our nursing leadership team, you will be responsible for overseeing the delivery of high-quality patient care, managing staff, and driving...
-
Art Director Graphic Design
2 days ago
Somerville, Massachusetts, United States PUMA Group Full timeJob Title: Art Director Graphic DesignPUMA Group is seeking an Art Director with a Graphic Design background to join our Creative Services team in Boston. As a key member of our internal creative agency, you will be responsible for creating original solutions for consumer experiences, including OOH, Digital, and Retail assets.Key Responsibilities:Utilize...
-
Somerville, Massachusetts, United States Mass General Brigham Health Plan Full timeJob SummaryWe are seeking a highly skilled and experienced Medical Director to lead our Medicare and Special Investigations Unit. The successful candidate will be responsible for providing clinical oversight and leadership for the Medicare Advantage line of business, as well as overseeing clinical review and responsibilities for the Special Investigation...
-
Director of Environmental Health and Safety
2 weeks ago
Somerville, Massachusetts, United States Ferreira Construction Co Inc Full timeJob Title: Director Environment Health SafetyThe Ferreira Group is a leading construction company that prioritizes the health and safety of its employees, clients, and the environment. We are seeking a highly skilled and experienced Director of Environmental Health and Safety to join our team.Job Summary:The Director of Environmental Health and Safety will...