Careers

About Inhibikase

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of pulmonary arterial hypertension (PAH).

Accounting Manager

Inhibikase is seeking a highly motivated finance professional to play a significant role in carrying out the accounting responsibilities of the company. The right candidate will have relevant experience in the biotech/pharma industry and bring a positive attitude with the ability to multi-task and meet required reporting deadlines. The Accounting Manager is primarily responsible for managing the month-end close process and completing monthly account reconciliations and journal entries, as well as assisting with systems implementations and other projects. This position will report to the Senior Director, Corporate Controller.

Key Responsibilities

• Manage the month-end / quarter-end close tasks and checklist
• Prepare journal entries and reconciliations for all balance sheet accounts
• Calculate and record various accruals, including clinical trial and contract manufacturing accruals
• Prepare bank and investment account reconciliations and record related journal entries
• Ensure controls are performed in accordance with SOX narratives
• Provide support for internal control walkthroughs and testing
• Assist with managing AP process, including review of credit card transactions and expense reporting
• Review vendor invoices for proper GL coding and posting dates
• Provide support for external financial audits and tax reporting
• Assist with various systems implementations and workflow improvements (including PO system and expense reporting system)
• Manage and record semi-monthly payroll processing and reporting
• Ensure compliance with US GAAP
• Assist Finance team with ad hoc projects as needed

Education and Training

• BS in Accounting or Finance required, MSA/MBA preferred
• CPA a plus
• 7+ years of experience
• Life science industry experience a plus
• Public company experience a plus
• Knowledge of US GAAP
• Experience with managing the financial close and recording R&D accruals
• Experience with ERP systems (Sage and/or NetSuite a plus)

Skills and Abilities

• Highly motivated
• Strong attention to detail
• Ability to multi-task and meet tight deadlines
• Positive and collaborative attitude
• Excellent organizational and communication skills
• Team player
• Highly proficient in Microsoft Office (namely Excel)

Inhibikase is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, veteran status, or any other status protected under federal, state, or local law.

Please send resumes and expression of interest to: careers@inhibikase.com

About Inhibikase                                                         

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), is a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of pulmonary arterial hypertension (PAH). 

In-House Clinical Research Associate (IHCRA)

We are seeking a dynamic individual in the role of an in-house Clinical Research Associate to support and manage start-up and execution activities of clinical trials. The ideal candidate thrives in a fast-paced, small-company environment where daily activities can fluctuate, requiring prioritization, flexibility and the ability to navigate uncertainty. Reporting directly to the Global Trial lead (Sr. Clinical Trial Manager and above).  The In-house Clinical Research Associate (IHCRA) supports the clinical trial by managing and oversee clinical study site activities.  This role will serve as Inhibikase primary liaison with the clinical study sites and contribute to building a culture of team, site and patient centricity. This role is accountable for clinical site activities from site identification through close out of the study site.  The CRA has ‘in-house’ responsibilities (e.g., management/oversight of vendors, enrollment tracking, data tracking), and as required by project scope, performs visits at the clinical study sites (e.g., oversight activities, co-monitoring visits).  The IHCRA, under the direction of the Global Trial Lead independently collaborates with the Clinical Trial Manager and/or Site Monitor. 

Responsibilities

In-house responsibilities 

• Assists and contributes to the development of study documents (e.g., protocols, case report forms, informed consent forms) 
• Assist with the development and implementation of project specific processes, tools, and documents (e.g., annotated visit reports, site email templates, site trackers) 
• Coordinate or manages, either directly or through supervised delegation, study-wide activities such as external vendors, recruitment efforts, sample handling, data review, and Trial Master File review 
• Assist with the identification and selection of appropriate clinical trial sites and investigators 
• Supports field based CRAs to provide them EDC metrics to manage site’s data entry and query resolutions
• Support site engagement with the site and serve as a site liaison
• Supports and contributes to eTMF – completeness, timeliness, and quality on assigned programs.  Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance of CRO and Sponsor files  
• Participate in internal and external study team meetings  
• Assist with investigator meeting preparations, including the creation of training materials for both CROs and clinical study sites, and helps coordinate the investigator meeting planning and logistics 
• Assist with tracking study metrics (e.g., monitoring KPIs) for report to management 
• Reviews CRO site visit reports and generates oversight visit reports;
• Performs oversight on CROs monitoring activities including the resolution of action items and protocol deviations
• Oversee CROs monitoring metrics inclusive of SDV data
• May support some aspects of study level vendor management  
• May support study team on some aspects of internal clinical data review  

Field monitoring responsibilities 

• May attend oversight monitoring visits to evaluate site and site monitor performance 
• May support routine study visits as needed to qualify, initiate, and close-out study sites, and perform site monitoring to ensure study sites’ compliance with study timelines, protocol requirements, and applicable regulatory guidelines 
• May review and ensure data integrity, accuracy, and completeness at the clinical study sites 
• Escalate site related issues to the study team 
• Ability to travel up to approximately 25% 

Education and Training

• Bachelor's degree or higher, with 4-6 years of experience with at least 1 year working in biotech/CRO in a similar or lesser role
• Experience with on-site or remote monitoring experience desired
• Experience working in a fast-paced and dynamic environment 
• Certification as a Clinical Research Associate (CCRA) or equivalent a plus
• Knowledge of therapeutic areas relevant to Inhibikase’s portfolio a plus  

 Skills and Abilities

• Working knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations 
• Knowledgeable with the CDISC TMF reference model 
• Good communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight  
• Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems 
• Proficient computer skills and standard Microsoft Office Suite (Word, Excel, PowerPoint)
• Knowledgeable of clinical trial processes and study conduct 
• Excellent organizational and time management skills 
• Strong critical thinking and problem-solving skills
• Detailed oriented 

Inhibikase is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical​​​ condition, pregnancy, genetic information, gender, sexual orientation, veteran status, or any other status protected under federal, state, or local law.

Please send resumes and expression of interest to: careers@inhibikase.com

About Inhibikase

Inhibikase is Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of pulmonary arterial hypertension (PAH).

Clinical Trial Assistant (CTA)

We are seeking a dynamic individual for the role of Clinical Trial Assistant (CTA) that can support the start-up and execution of clinical trials. The ideal candidate thrives in a fast-paced, small-company environment where daily activities can fluctuate, requiring prioritization, flexibility and the ability to navigate uncertainty. Reporting directly to Director level and above. The CTA supports the Clinical Trial Team in the planning, designing, executing, monitoring, and reporting of trial milestones. This may include creation of study documents, implementing and maintaining trackers, coordinating vendor payments and supplies, and support cross-functional study staff with related administrative activities. The CTA, under the direction and guidance of the Global Trial Lead will support and collaborate with other functional members as needed.

Responsibilities

• Acts as a central contact for the Clinical Trial Team for designated project communications, correspondence, and associated documentation.
• Supports the Clinical Trial Team cross-functionally as necessary to complete all study activities
• Supports the set up and maintain study specific electronic Trial Master Files
• Supports tracking of study specific training
• Performs Quality Control (QC) reviews of essential study documents and Trial Master Files (TMF) to ensure ongoing inspection readiness and compliance with applicable regulations and Good Clinical Practices
• Supports team in completing and reviewing of site documentation (CDAs, Contracts, Licenses, 1572s, CVs, Financial Disclosure forms, etc.)
• Prepares and tracks study documents (e.g., contracts, budgets, IRB documentation, sample management, etc.)
• Organize and/or participate in meetings internally and externally. Ensure appropriate meeting minutes are prepared, reviewed and filed in TMF
• Supports logistics and development of materials for Investigator Site meetings
• Can prioritize and use time efficiently to meet deadlines

Education and Training

• Associate degree or higher, with 1-3 years of relevant experience in Clinical Trial or related discipline in life sciences 
• Knowledgeable at managing multiple tasks and multifunctional resources concurrently while maintaining high attention to detail and responding to rapidly changing priorities
• Knowledgeable in Microsoft suite of products; Microsoft Word, Excel, PowerPoint, Outlook, etc. 

 Skills and Abilities

• Knowledgeable at ICH/GCP and applicable regulations 
• Knowledgeable with the CDISC TMF reference model 
• Able to communicate in written, verbal and face-to-face communication to present information internally and externally as needed 
• Strong critical thinking and problem-solving skills
• Able to develop organizational, communication and presentation skills
• Detailed oriented

Inhibikase is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical​​​ condition, pregnancy, genetic information, gender, sexual orientation, veteran status, or any other status protected under federal, state, or local law.

Please send resumes and expression of interest to: careers@inhibikase.com

About Inhibikase                                                         

Inhibikase is Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of pulmonary arterial hypertension (PAH). 

Senior Clinical Trial Manager (Sr. CTM)

We are seeking a dynamic and experienced Senior Clinical Trial Manager. This role requires a self-motivated person who can manage the start-up and execution of large, global clinical trials. The ideal candidate thrives in a fast-paced, small-company environment where daily activities can fluctuate, requiring prioritization, flexibility and the ability to navigate uncertainty. Reporting directly to a Director level in Clinical Operations. The Senior CTM is accountable for operational planning and execution at the study or regional level with responsibility for the overall or regional clinical study plan and implementation (start up thru close out), including timeline, quality, and budget. A key focus will be the oversight of and interactions with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission/inspections. The Senior CTM will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries and is expected to provide leadership within Global Clinical Operations and guidance with regards to operational deliverables.

Responsibilities

• Accountable for overall or regional management of assigned clinical trial
• Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols.
• Responsible for managing relationships with CROs and other vendors for all study activities including study start-up, close out, and completion of Trial Master File.
• Demonstrates consistent and regular Sponsor Oversight and performance management for all utilized vendors and/or CRO third party contracted vendors.
• Responsible for accurate drug accountability/reconciliation for investigational product (IP) issued during the trial to the site and at the end of the trial
• Responsible for ensuring sufficient ancillary supplies are available and shipped for the trial (i.e., templates, binders, forms, supplies, etc.)
• Proactively identify and resolve issues that arise during the course of the trial, maintaining a sense of urgency and attention to detail.
• Works cross-functionally to establish and ensure clinical trial timelines and goals are met and risks are appropriately escalated to Management.
• Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion.
• Experienced in developing all Clinical trial plans including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets.
• Collaborate with the CRO in the collection, preparation, and review of regulatory documentation prior to study start-up.
• Responsible for the set-up of all third-party vendor specifications (i.e. IWRS, eCRF, central laboratory/ECG, etc.) and on-time third party deliverables.
• Responsible for negotiating site Clinical Trial Agreements in conjunction with the Legal Department and CRO.
• Responsible for vendor budget, invoice review and study scope changes
• Accountable for eTMF – completeness, timeliness, and quality on assigned programs. Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance of CRO and Sponsor files.
• Responsible for participating in and presenting at Investigator Meetings, SIVs and other program meetings.
• Support trial-related audits and inspections as needed, ensuring complete and accurate documentation is available.
• Demonstrated success in managing teams, including mentoring Clinical Trial Associates or similar roles.
• Ability to travel 25% including possible international travel.

Education and Training

• Bachelor's degree with a minimum of 8-10 years of experience within the pharmaceutical, biotechnology industry with a minimum of 2 years of experience in Biotech industry strongly preferred.
• Experience with Phase 1 and Phase 2 global trials
• Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight
• Experience working in a fast-paced and dynamic environment
• Knowledge in cardio-pulmonary therapeutic area relevant to Inhibikase’s portfolio a plus
• Additional Certifications a plus

 Skills and Abilities

• Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations
• Experienced with the CDISC TMF reference model
• Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight
• Experienced with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
• Excellent presentation skills and the ability to present scientific information to varied audiences
• Excellent computer skills and standard Microsoft Office Suite (Word, Excel, PowerPoint)
• Excellent written, verbal and face-to-face communication to present information internally and externally as needed
• Excellent organizational and time management skills
• Strong critical thinking and problem-solving skills
• Detailed oriented

Inhibikase is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, veteran status, or any other status protected under federal, state, or local law.

Please send resumes and expression of interest to: careers@inhibikase.com