Clinical Trial Manager, Clinical Operations
Apply NowCompany: Stoke Therapeutics, Inc.
Location: Bedford, MA 01730
Description:
About Stoke:
Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to addressing the underlying cause of severe diseases. The company is pursuing an entirely new approach to treating severe diseases. We are initially focused on diseases of the central nervous system and the eye, with an emphasis on haploinsufficiencies, which are diseases caused by a loss of about half of the normal protein levels. Rather than replace, repair or edit faulty genes, we aim to increase - or stoke - protein output from healthy genes to restore functional protein levels using our proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) platform. In all, Stoke has identified ~6500 genes with a TANGO signature, representing broad potential for our approach to help people with severe diseases.
We recently announced landmark data that support the potential for STK-001 to be the first disease-modifying medicine for Dravet syndrome, a severe and progressive genetic epilepsy that is characterized by frequent, prolonged and refractory seizures, beginning within the first year of life. The disease is classified as a developmental and epileptic encephalopathy due to the developmental delays and cognitive impairment associated with the disease.
Stoke is also advancing STK-002, a potential treatment for autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Currently there are no approved treatments for ADOA. Clinical studies of STK-002 are anticipated to start in 2024. The company is pursuing potential new medicines for three additional neurodevelopmental disorders, including Syngap1 and Rett syndrome, in collaboration with Acadia Pharmaceuticals.
Position Purpose:
The Clinical Trials Manager (CTM) is responsible for the successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables. The CTM typically works on studies with moderate complexity (in terms of design, location, phase, etc.), and proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required. The CTM assures that the study is conducted per protocol, per business requirements (e.g., timing and budget), and in accordance with applicable regulations and guidance. The CTM is responsible for a broad scope of varying activities to support both department and corporate goals.
Key Responsibilities:
Required Skills & Experience:
Location(s):
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is a hybrid position with an office setting based in our Bedford, MA and/or Cambridge, MA location.
Travel:
This position will require approximately 5% travel.
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. 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 Committee (DIB) underscores the importance of DIB to who we are and what we do.
Benefits & Compensation:
At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible.
Interested candidates: Please visit Stoke's website to learn more and apply directly to the position listed on our Career Center:
https://www.stoketherapeutics.com/careers/
For more information, visit https://www.stoketherapeutics.com/ or follow the company on Twitter at @StokeTx.
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.
Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to addressing the underlying cause of severe diseases. The company is pursuing an entirely new approach to treating severe diseases. We are initially focused on diseases of the central nervous system and the eye, with an emphasis on haploinsufficiencies, which are diseases caused by a loss of about half of the normal protein levels. Rather than replace, repair or edit faulty genes, we aim to increase - or stoke - protein output from healthy genes to restore functional protein levels using our proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) platform. In all, Stoke has identified ~6500 genes with a TANGO signature, representing broad potential for our approach to help people with severe diseases.
We recently announced landmark data that support the potential for STK-001 to be the first disease-modifying medicine for Dravet syndrome, a severe and progressive genetic epilepsy that is characterized by frequent, prolonged and refractory seizures, beginning within the first year of life. The disease is classified as a developmental and epileptic encephalopathy due to the developmental delays and cognitive impairment associated with the disease.
Stoke is also advancing STK-002, a potential treatment for autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Currently there are no approved treatments for ADOA. Clinical studies of STK-002 are anticipated to start in 2024. The company is pursuing potential new medicines for three additional neurodevelopmental disorders, including Syngap1 and Rett syndrome, in collaboration with Acadia Pharmaceuticals.
Position Purpose:
The Clinical Trials Manager (CTM) is responsible for the successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables. The CTM typically works on studies with moderate complexity (in terms of design, location, phase, etc.), and proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required. The CTM assures that the study is conducted per protocol, per business requirements (e.g., timing and budget), and in accordance with applicable regulations and guidance. The CTM is responsible for a broad scope of varying activities to support both department and corporate goals.
Key Responsibilities:
- Work in a matrix management organization, responsible for leading and managing all aspects of assigned clinical study(ies) (i.e. Phase 1-3, Open Label Extensions) with partner CROs and vendors, by ensuring assigned studies are conducted according to timelines and budget per the Clinical Development Plan (CDP).
- Assume a lead role in the identification process of Investigators and vendors, and oversight of clinical site and vendor qualification prior to study execution.
- Provides input into clinical study protocols, informed consent forms (ICFs) and other clinical study documents.
- Develop and oversight of study operational plans to ensure study compliance and quality is maintained.
- Oversees the development of and adherence to clinical study timelines as per the Clinical Development Plan (CDP) and collaborates with internal functional stakeholders for alignment.
- Proactively identify study risks and coordinate risk identification and mitigations with the study team, CRO and vendors.
- Coordinates the relevant and timely exchange of study status with internal functional stakeholders to support clinical study delivery per the CDP.
- Coordinates with CMC regarding drug forecasting and supply of drug products to sites.
- Supports timely and efficient database lock by ensuring monitoring plans are in place and by participating in data review / reconciliation efforts.
- Adheres to clinical study budgeting process and provides input to finance on budget accruals and forecasts.
- Participates in clinical study scenario planning (estimates timelines and cost) with support and alignment with the Director, Clinical Operations.
- Utilizes project management skills to ensure consistency in processes and drive Clinical Operations performance.
- Demonstrates a high level of knowledge of clinical operations' methodologies, organizational, project management and study team leadership capabilities.
- Actively participates in the development of department initiatives, including the development /definition of SOPs and processes.
Required Skills & Experience:
- Strong knowledge of ICH-GCP guidelines and regulations.
- Strong knowledge of Drug Development process
- Bachelor's degree or higher in a scientific or healthcare discipline preferred.
- Minimum of 4-6 years of progressive experience in clinical operations within biotech, pharmaceutical, CRO industry or equivalent clinical research experience.
- Experience conducting and/or overseeing PSVs, SIVs, IMVs, and COVs required.
- Rare Disease and Neurology clinical study experience are highly desirable.
- Proficiency in Microsoft Word, Excel, and Outlook, PowerPoint, and MS Project
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively, as required, in a fast-paced start-up environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Location(s):
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is a hybrid position with an office setting based in our Bedford, MA and/or Cambridge, MA location.
Travel:
This position will require approximately 5% travel.
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. 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 Committee (DIB) underscores the importance of DIB to who we are and what we do.
Benefits & Compensation:
At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible.
Interested candidates: Please visit Stoke's website to learn more and apply directly to the position listed on our Career Center:
https://www.stoketherapeutics.com/careers/
For more information, visit https://www.stoketherapeutics.com/ or follow the company on Twitter at @StokeTx.
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.