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

Accounting Manager: Apply Now

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

Senior Clinical Trial Manager (Sr. CTM): Apply Now

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).

Global Regulatory Lead

The Global Regulatory Lead (GRL) will have leadership responsibility for global regulatory strategy within a Clinical Development Team (CDT).  They serve as team leaders or co-lead of marketing application submission teams for indications that are in late-stage development.

• Lead the development of strategy and content for global dossiers
• Develop target labeling and co-lead the cross-functional labeling team. Ensure consistent positions are presented in responses to global health authority (HA) queries
• Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input
• In collaboration with the EU regulatory leader, we develop global submission plans and HA interaction plans
• Provide input into the development of protocol synopses and protocols
• Co-lead the cross-functional response teams to respond to IND and Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines 

Responsibilities

• Participating in Clinical Development Team. Provide leadership to the CDT on critical project issues
• Lead the development of regulatory pathways and plans for product registration, including associated risk assessments and identification of precedence
• Lead the identification of innovative approaches to resolve complex regulatory issues and increase speed to market
• Lead the content planning for regulatory submissions, strategic documentation and project reviews. Align regulatory plans with commercial and development plans
• Establish one regulatory voice for communication with key stakeholders
• Participate in the development of strategies for product partnering (out-licensing, divestiture, co-development, in-licensing, and acquisitions)
• Assure that priority market and non-priority market regulatory issues are addressed in the global development plan
• Assure CMC elements of the overall global regulatory plan are robust
• Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, etc. Review and approve key regulatory documents, including IBs, INDs, IMPDs, CTAs, RMPs, Pediatric Plans etc.
• Facilitate identification and internal agreement of optimal product labeling. Provide strategic input on Target Product Profile, CCDS and country-specific labels
• Support effective interactions with HAs globally. Create an asset-specific global HA interaction strategy, integrating regional/local objectives and strategies.  Support the preparation of, and participate in/lead (as appropriate), key HA interactions.  Assure consistent positions on common issues are presented to global HAs.  Review and approve content of responses to queries from HAs for respective regions/countries
• Drive the creation and execution of the global submission plan. Formulate integrated global submission plan for simultaneous filings and communicate rationale for deviation from simultaneous submissions

Education and Experience

• Solid scientific background, Ph.D., M.D., PharmD, MS, or BS with equivalent professional experience
• Understanding medical and scientific content and associated complexities
• Significant knowledge of the drug development process is required
• Understanding of strategic and tactical role and deliverables of regulatory strategy in the product development and commercialization process
• Understanding policy, laws, regulations and guidelines as they apply to HAs globally for drug development and approval
• Strong interpersonal skills: willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment
• Experience in successfully leading submission teams
• Direct experience in developing strategy and leading teams through interactions with health authorities
• Track record of resolving issues with HAs
• Experience in developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives
• Experience in communicating the regulatory strategy, issues, and risks in written and verbal format to management and other governing bodies
• Ability to broadly represent department functions on project team in a matrix organization.
• Demonstrated ability to coordinate global activities, drive quality decision-making, organize/prioritize tasks, negotiate with and influence others, and facilitate issue resolution and conflict management

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

Global Regulatory Lead: Apply Now