ARKAY Therapeutics is a privately-held pharmaceutical company developing novel and innovative pancreatic beta-cell combination products for the treatment of Type II diabetes and Prediabetes. The company has filed U.S. and PCT patent applications. ARKAY has completed proof-of-concept pre-clinical studies and is advancing its clinical candidate, RK-01. The Company has assembled a world-class team of board members and scientific advisors. Please visit www.arkaytherapeutics.com to learn why now is an excellent time to seize this exciting opportunity.
Chief Financial Officer
As a key member of the Executive Management team, the Chief Financial Officer will report to the Chief Executive Officer and assume a strategic role in the overall management of the company. The CFO will have primary day-to-day responsibility for planning, implementing, managing and controlling all financial-related activities of the company. This will include direct responsibility for accounting, finance, forecasting, strategic planning, job costing, legal, property management, deal analysis and negotiations, investor relationships and partnership compliance and private and institutional financing.
- Provides leadership in the development for the continuous evaluation of short and long-term strategic financial objectives.
- Reach out to angel investors and VCs to raise capital.
- Contribute to refining company’s pitch to the investors, pitch to the investors and play a lead role in raising capital for the company.
- Ensure credibility of Finance group by providing timely and accurate analysis of budgets, financial trends and forecasts.
- Take hands-on lead position of developing, implementing, and maintaining a comprehensive job cost system.
- Direct and oversee all aspects of the Finance & Accounting functions of the organization.
- Evaluates and advises on the impact of long range planning, introduction of new programs/ strategies and regulatory action.
- Establish and maintain strong relationships with senior executives so as to identify their needs and seek full range of business solutions.
- Provide executive management with advice on the financial implications of business activities.
- Manage processes for financial forecasting, budgets and consolidation and reporting to the Company.
- Provide recommendations to strategically enhance financial performance and business opportunities.
- Ensure that effective internal controls are in place and ensure compliance with GAAP and applicable federal, state and local regulatory laws and rules for financial and tax reporting.
Qualifications & Requirements:
- BS in Accounting or Finance, MBA and/or CPA highly desirable.
- 10+ years in progressively responsible financial leadership roles, preferably in pharmaceutical industry in general, start-up biopharmaceutical industry environment in particular.
- Ability to travel, up to 25% travel time.
- A track record for raising capital for life science companies.
- Strong interpersonal skills, ability to communicate and manage well at all levels of the organization essential.
- Strong problem solving and creative skills and the ability to exercise sound judgment and make decisions based on accurate and timely analyses.
- High level of integrity and dependability with a strong sense of urgency and results-orientation. Emotional maturity and ability to effectively facilitate change in an environment where the structure may evolve rapidly.
Other Skills & Abilities:
PC proficiency is essential (Windows environment) and strong working knowledge of GANNT chart software and Excel is preferred.
Chief Medical Officer
The Chief Medical Officer is a key member of the Senior Executive team and reports to the Chief Executive Officer. The Vice President & Chief Medical Officer for ARKAY will possess extensive experience in advancing clinical trials successfully. With a background in metabolic diseases, cardiovascular diseases and chronic Inflammatory diseases. The successful candidate will bring a robust knowledge of Protocol design, experience in working with Key Opinion Leaders and overseeing, implementation and execution of successful clinical trials to the position. The candidate will be a strong leader and strategic thinker with a background in a high productivity environment.
- MD, MD/PhD with 10+ years of experience in investigational drug development.
- Board certification in endocrinology with experience in diabetes.
- Experience in a related therapeutic specialty such as cardiovascular disease and chronic Inflammatory or other related specialty.
- Pharmaceutical industry experience in the successful development, registration and commercialization of new drug products is preferred.
- Experience in pharmaceutical or biotech industry working with Phase 1-3 clinical trials, and/or serving as principal investigator with a background in clinical trial design and protocol development.
- Familiarity with ICH guidelines and FDA requirements.
- Experience working with Contract Research Organizations is a must.
- A working knowledge of biostatistics as relevant to the design and analysis of clinical trials.
- Ability to travel, up to 25% travel time.
- Prior experience at senior levels working in and/or leading cross-functional teams.
- Team player with executive presence and demeanor coupled with excellent written and verbal communication skills as well as outstanding analytical abilities.
- Comfortable working both internally and externally with technical and medical experts in providing input into future drug development strategies.
- Independent, self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive management style.
Scope of Responsibility
- Supervises and directs the activities of other Clinical Research staff to include Biostatistics, Data Management, Clinical Operations, Regulatory, Quality and Medical Affairs.
- Responsible for clinical development strategies including Phase 1 through 3, lifecycle management, medical affairs, safety responsibilities, scientific interactions with regulatory bodies, and interactions with corporate partner(s).
- Leads and oversees the strategic definition and tactical development of clinical trials programs, including protocol writing, interpretation of clinical data, and literature reviews.
- Ensures the consistent application of state-of-the-art scientific and ethical methods to design clinical investigational trials of the highest quality.
- Ensures that all clinical trials are in keeping with approved timelines and budgets, with potential obstacles identified and solutions implemented to avoid delays in clinical trial implementation.
- Ensures the work with colleagues and collaborators are coordinated and that all people, systems, processes and materials required for clinical trials are available and appropriately prepared.
- Ensures that clinical trials are conducted in accordance with applicable regulatory requirements and guidelines.
- Ensures the identification, recruitment and selection of appropriate clinical investigators and contract research organizations, resulting in appropriate negotiation of contracts.
- Ensures timely medical review and reporting of adverse events.
- Assists Regulatory Affairs to ensure the timely preparation of documents to be submitted to the FDA and other health authorities for review.
- Ensures the timely preparation of presentations reporting results of clinical trials to internal and external audiences.
- Collaborates with colleagues in discovery research and preclinical development line functions to move product candidates for entry into clinical investigations.
- May represent the Clinical Research line function on multidisciplinary project teams.
- Participates as an active member of the executive team of the company.
- Works with marketing to evaluate product candidates, determine product indications and design post-marketing studies, as appropriate.
Desirable Traits & Skills
- Well-developed problem solving skills combined with experience working with outside consultants in a positive and collaborative fashion.
- Excellent oral, written and presentation skills.
- High energy, enthusiastic, goal driven.
- Enjoys being ‘hands-on’ and able to work in a ‘virtual’ environment. Adept at managing external service providers to meet objectives and budgets.
- A demonstrated track record in the clinical development process with experience in successfully compressing the cycle of getting drugs to market.
- Fast learner with ability to deal with technical and business issues with equal skill and able to deal with many ambiguities inherent in an emerging pharmaceutical company without becoming rigid or mechanical.
- Able to work in an environment where sharing responsibility for success and the shortcomings of others on the team is critical to the overall success of the Company.
- Emotional maturity and ability to effectively facilitate change in an environment where the structure may evolve rapidly.