Stoke Therapeutics

Director, Global Regulatory Affairs

Bedford, Massachusetts, United States · Director

Sponsorship not specified$248k-$280kDetected 28 days ago

NegotiationFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingRegulatory Affairs

About the role

About Stoke: Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine.
Stoke's first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study.
Stoke's initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency).

Defines and drives regulatory strategy for assigned activities/programs.
Oversee preparation and submission of global regulatory submissions to support program development, registration and maintenance activities.
Develops and maintains current regulatory knowledge and provides guidance to regulatory staff and company management
Develops and maintains current regulatory knowledge and provides guidance to regulatory staff and company management; identifies the need for new or expanded regulatory policies, processes and SOPs, and approves and ensures implementation to establish a compliant culture.
Our values guide our work to deliver meaningful medicines for people who need them.

Experience in the preparation of major regulatory submissions and supportive amendments or supplements for programs, including both early phase and late phase aspects of the project
direct experience in interfacing with relevant regulatory authorities.
Well organized, self-motivated hard worker, smart independent thinker, demonstrated ability to work well under pressure and deadlines, detail oriented, with effective written and oral communication skills.
Required Skills & Experience:

8+ years minimum of Regulatory Affairs experience in the pharmaceutical industry.
S., M.S. or Ph.D. in a scientific discipline preferred
Experience in rare disease drug development preferred and neurology indications ideal.
Excellent verbal, written, negotiation, and interpersonal skills.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

The anticipated salary range for this role is $248,000 - $280,000.
In addition to base salary, Stoke offers an annual bonus and equity participation.
Culture & Values:
At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically.
We allow for flexibility in work arrangements that balance individual's needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.
Our values guide our work to deliver meaningful medicines for people who need them.

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.
In addition to base salary, Stoke offers an annual bonus and equity participation.
The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location.

STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine.
Using Stoke's proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels.
Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke's proprietary approach.
Stoke is headquartered in Bedford, Massachusetts.
For more information, visit https://www.stoketherapeutics.com/
At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically.
We allow for flexibility in work arrangements that balance individual's needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.
We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us.
We embrace diversity within a unique culture that is defined by our values.
Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do.

https://www.stoketherapeutics.com/careers/
All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.
Stoke participates in E-Verify.

This listing is sourced directly from Stoke Therapeutics's careers page and normalized into a canonical job model.