Careers

Your Path to Endless Opportunities

If you’re looking to push the envelope and join an innovative company where technology meets drug discovery and development and you’re enthusiastic, creative, with a passion for cutting-edge research, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of oncology and neuroscience programs, as well as for our partners across major therapeutic areas.

Are You Ready to be Part of the Next Innovation?

The AVP/Executive Director of Managed Markets Access, Value, and Strategy will play a critical role in driving a successful launch of BXCL501 with focus on achieving broad formulary access across managed care and hospital accounts. The position will be responsible for developing the overall market access launch plan for BXCL501, including strategy for pricing, hospital-associated reimbursement, and formulary coverage, as well as the development of marketing plans and communications programs to promote BXCL501’s clinical and economic benefits with payers and customer accounts.  Effectively and efficiently interfacing with customers, internal and external team members, partners and vendors is a critical component of this position.

MAJOR ACTIVITIES AND RESPONSIBILITIES

  • Partner cross-functionally to lead the development of US Payer access strategies and payer launch readiness plans for BXCL501 and pipeline products
  • Develop payer channel and customer insights to inform launch access strategies and annual operating plans
  • Define critical processes and timelines across payer types to establish rapid access, formulary coverage and reimbursement 
  • Develop payer segmentation and prioritization plans with defined customer engagement timelines
  • Develop payer value proposition and associated messaging platform
  • Support channel optimization planning across IDNs, hospital systems/hospitals, long-term care, drug treatment centers, and the retail marketplace
  • Lead the creation, editing, production and deployment of digital and non-digital communications programs (message platform and sales aid, educational programs, conference booths and materials, relationship marketing programs, promotional campaigns, training materials, etc.) to support the overall product strategy and corporate objectives with managed markets customers
  • Develop success metrics and measurements for market access initiatives and programs.
  • Generate insights from monitoring and analyzing market trends and competitor activities to identify opportunities and overcome potential challenges.
  • Build and lead the Managed Markets Marketing team including recruiting, training, and managing talent to achieve company an brand goals

BACKGROUND REQUIREMENTS

  • Master’s degree or doctoral degree (in a relevant field)
  • Minimum 10 years of pharmaceutical industry experience
  • People management experience and success
  • Knowledge of the IDN and hospital marketplace
  • Analytical skills
  • Ability to work across multiple stakeholders
  • Strong creative and conceptual thinking skills
  • Clear communication skills, both verbal/presentation and written
  • Strong interpersonal skills
  • Financial/budgetary experience
  • Ability to travel up to 25%
AVP/Executive Director, Managed Markets Access, Value, and Strategy: Apply Now

Reports To

The Clinical Operations Professional will report to VP and Head, Clinical Operations and Project Management. 

Job Overview

Responsible for all operational aspects of assigned global clinical research activities and will liaise closely with other departments as well as with CRO/vendors. Responsible for appropriate execution and oversight of clinical operational development for several trials in various indications. Accountable for all activities associated, directly or indirectly with trial execution and clinical development, reporting and submission activities of the compound, as appropriate. Job title/role can be tailored to the right individual based on a combination of strengths and experience 

Responsibilities and Duties

  • Oversee and manage clinical operations activities to successfully execute the assigned clinical trial globally.
  • Ensure that all work is carried out in strict adherence with relevant protocols, SOPs, and in compliance with FDA and global health authority regulations and guidelines, as well as ICH/GCP
  • Oversees study operational teams and manages resources to ensure that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission.
  • Actively contributes to Clinical Operations departmental activities and process improvement
  • Ensure timely feedback on study deliverables and reporting to senior leadership.
  • Develop, amend, and review clinical documents such as protocols, ICFs, Investigator Brochures, clinical reports, pharmacy manual and any other documents/plans supporting multiple clinical
  • Develop standards for internal documents such as: protocols, ICFs, safety management plans,
  • Training and oversight of all vendors associated with the assigned clinical trial.
  • Coordinate and drive clinical development programs with appropriate U.S. and International focus.
  • Provide routine direction, guidance and mentorship to clinical operations
  • Prepare or supervise preparation of a clinical monitoring plan for each project with realistic
  • Supervise conduct of clinical programs to ensure on time and on budget delivery of clinical
  • Manage staff to monitor clinical programs and studies for protocol compliance, user interface with product, and accuracy of
  • Prepare and manage the annual clinical operations
  • Ensures accurate documentation and control of all essential study documents, with the support of QA/Compliance.
  • Oversee the development of program and study timelines and
  • Oversee external vendors including research organizations, CROs, and central
  • Review and approve all research agreements and confidentiality requirements.
  • Any other responsibilities assigned by direct manager

Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy or Medicine required; advanced degree preferred, i.e. PhD, PharmD, MS, MPH.
  • At least 7+ years of clinical research experience in a pharmaceutical, biotech, or medical device industry is required; including 4+ years of clinical program management experience.
  • Experience managing a CRO partner in the conduct of clinical studies is required.
  • Knowledge and understanding of current regulations related to Phase I through IV clinical research.
  • Strong working knowledge of IRB regulations, GCP/ICH guidelines.
  • Knowledge of project management tools and practices.
  • Ability to understand and review detailed clinical reports.
  • Deep understanding of therapeutic area.
  • Experience managing a team of Clinical Operations staff with a demonstrated track record of effective clinical management.
  • Experience managing a budget and other concurrent multiple projects.
  • Solid basis in scientific approach and an ability to deal with in-depth technical information.
  • Fosters a high degree of scientific credibility with clinical agencies.
  • Demonstrated ability to manage conflict situations.
  • Ability to comfortably interact and clearly communicate with individuals at all levels of the organization including working closely with senior management.
  • Excellent verbal and written communication skills.
  • Ability to multi-task and prioritize.
  • Experience in Clinical Research Monitoring and Clinical Project Management; Comprehensive knowledge of Microsoft Word, Excel and PowerPoint.
Clinical Operations Professional: Apply Now

Reports To

The Chief Financial Officer

Job Overview

Responsible for monitoring the Company’s financial direction by the preparation and analysis of budgets, forecasts and management reporting. Coordinate with the rest of the finance team in meeting deadlines for financial reports provided to the Securities & Exchange Commission, Internal Revenue Service and other government agencies.

Responsibilities and Duties

  • Preparation of budget and updates of budgets and forecasts.
  • Assume responsibility for the installation of the Me brokerage and reporting system for the Company’s Incentive Award programs. Vetting of information, input of new grants, footnote disclosure, DWAC coordination, control log etc.
  • Coordination of the reporting for the Company’s clinical trials accruals.
  • Preparation and review of the Company’s Tax footnotes in coordination with EisnerAmper (“EA”) and BDO. Provide supplemental information to EA for completion of tax returns.
  • Comparison of actual to budgeted results and related commentary.
  • Assist in the identification and implementation of a new accounting software system.
  • Assist in the identification and implementation of a new Expense Report software system.
  • Present Quarterly and Annual Results at the Board of Directors meetings.
  • Maintain option and equity control logs.
  • Preparation of two journal entries [will assist in knowledge of systems & backup for Controller]
  • Ad hoc reports.

Qualifications

  • Bachelors Degree in Accounting
  • Combination of Public and Private Accounting Experience.
  • Knowledge of internal controls.
  • Attention to detail.
  • Certified Public Accountant preferred but not required.
  • Knowledge of financial software applications.
  • Seasoned professional

We are an exciting growing biotechnology company offering an unlimited growth opportunity.  Please send us your resume and a cover letter.

Director Financial Planning and Analysis: Apply Now

Reports To

The Executive Director, Regulatory Affairs will report to the SVP & Head, Translational Medicine, Clin. Pharm. & Reg. Affairs.

Job Overview

The Executive Director, Regulatory Affairs will be responsible for developing and executing the global regulatory strategy for one or more projects. This individual will, with a high sense of urgency, provide strategic and operational regulatory input to cross-functional teams responsible for global development programs.  The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

Responsibilities and Duties

Provide a bullet point list of the responsibilities and duties of this job.

  • Using experience in regulatory affairs and drug development, prepares global regulatory strategy for compounds in development starting from IND/IMPD to NDA/MAA submissions.
    • Leads the development and preparation of regulatory documents, with input from global product team members. Documents must meet current regulatory standards (for e.g. FDA, EMA, MHRA, etc) and must be of high quality, consistent, and approvable by regulatory authorities. This includes, but may not be limited to, IND, Type B or C meeting documents, EOP2, NDA/MAA documents prepared in the electronic Common Technical Document (eCTD) format,
    • Responsible for the preparation of regulatory documents such as Orphan Drug Applications, Pediatric Study Plans, Pediatric Investigational Plans, EMA Scientific Advice documents, etc
    • Prepared DSUR and/other documents to meet annual reporting requirements
    • Leads IND maintenance to support all clinical development activities.
    • Manages and participates in post-approval, global product activities. This includes, but may not be limited to, change control, product complaints, supplements and variations leading to labeling updates.
    • Works with the team to develop a timeline for responding to regulatory inquiries from global regulatory agencies to ensure issues are addressed in a timely manner. Assists in the preparation and review of responses to global health authorities.
    • Participates in regulatory health authority meetings and assists with the preparation of meeting request, meeting packages and summaries/minutes.
    • Reviews and edits technical documents provided by the clinical, clinical pharmacology and nonclinical functions and extracts information necessary for regulatory submissions. This may also involve recommending changes to technical documents to ensure conformance with existing regulatory approvals.
    • Remains current on regulatory guidance documents from the FDA, EMA, ICH, etc.
  • Directs regulatory strategy development and implementation for allocated products. Effectively interprets regulatory guidance and provides recommendations to key stakeholders. 
  • Actively collaborates with development teams to execute US regulatory strategies and contingencies for assigned projects from IND, to NDA to post-marketing activities. Plans and manages regulatory activities, including the development and maintenance of regulatory budgets and timelines. Ensures adherence to relevant regulatory guidance and regulations, as well as company Standard Operating Procedures (SOPs).  Participates in decision-making and risk-management process.
  • Creates, maintains, and executes regulatory project plans, timelines, and other tools required to facilitate planning and coordination of deliverables for each assigned Project. Facilitates the development of the integrated project plans relevant to the regulatory deliverables and ensures alignment across relevant functions and smooth transitions among pipeline stages.  Facilitates contingency and risk mitigation planning.
  • Interacts with head of regulatory and other Sr. Management / executive levels. Exercises judgment and exerts influence on the overall objectives and long-range goals of assigned projects.  May represent the department in relevant internal/external committees.
  • Responsible for development and implementation of regulatory strategies for BXCL501 dementia, opioid withdrawal and follow up programs
  • Responsible for the development an implementation of regulatory strategies for BXCL701 including strategies for neuroendocrine prostate cancer and pancreatic cancer
  • Manages regulatory operations for programs under management

Qualifications

  • At least 15 years in pharmaceutical industry regulatory affairs, including experience in leading regulatory teams and participating in cross-functional development teams.
  • Strong knowledge of drug development and regulatory policy; excellent scientific and business judgment.
  • Experience in all phases of development across multiple therapeutic areas including IND, NDA, and CTA experience.

Education

  • Master’s, Pharm D, or PhD Degree in a related discipline
Executive Director, Regulatory Affairs: Apply Now

Mission:

Strategy and execution responsibility for the establishment and operation of BioXcel’s commercial pharmaceutical supply chain and distribution, including ownership of or contributions to global contract manufacturing/packaging, enterprise resource planning (ERP), development of BioXcel’s third-party logistics process, as well as Sales and Operations Planning (S&OP).

Duties & Responsibilities:

  • High-level strategic planning and analytical skills are required with ability to effectively communicate the vision for a successful global product supply and distribution system.
  • Partner with Drug Development and cross-functional leadership to ensure that the product distribution system and commercial supply agreements are established and ready to support product launches and ongoing supply.
  • Responsible for successful development and implementation of BioXcel’s long-term supply chain and distribution strategy including establishment of necessary company infrastructure, procedures, policies, and budgets.
  • Responsible for on-time manufacture and delivery of trade and sample products to the 3PL distributor and sales reps, avoids product stock-outs, and ensuring sufficient safety stock inventory at all times.
  • Contribute to selection and implementation of an ERP system and establish processes for use by the supply chain team
  • Coordinate manufacturing plans and evaluate supply chain redundancy needs, ensuring that necessary product manufacturing and distribution backup resources are in place to avoid failure of supply to the marketplace.
  • Responsible for developing strategic business plans and budgets for the Supply Chain and distribution functions.
  • Responsible for implementation of and ongoing compliance with DSCSA serialization requirements.
  • Sets company standards for the establishment of distribution practices and provides guidance for monitoring ongoing distribution key performance indicators to ensure the highest level of service is always provided to internal and external customers.
  • Establishes S&OP team and practices and provides leadership and direction to process and team
  • Provides leadership and direction for the hiring and development of the commercial supply chain team, as necessary.
  • Promotes best distribution practices with respect to efficiency and cost containment. Meets or exceeds Supply Chain and Distribution performance objectives.
  • Acts, as needed, to quickly implement corrective and preventive actions (CAPA) in the event of a Manufacturing or Distribution incident, Serious Adverse Event or Recall.

Knowledge and Skills:

  • Excellent leadership, verbal and written communication, and organizational skills.
  • Ability to develop corporate strategy as well as operationalize and execute on strategic directives.
  • Must be highly motivated with a strong work ethic and attention to detail. Ability to function independently and work with cross-functional teams in a highly dynamic work and geographically dispersed environment.
  • Must be knowledgeable in licensing, regulations and infrastructure required to establish a pharmaceutical distribution network within the US.
  • Fosters strong spirit of cooperation, and teamwork with contractors and colleagues, with an entrepreneurial and customer-focused orientation.
  • Knowledge of Good Distribution Practices and DSCSA product serialization requirements.
  • In-depth knowledge of rules and regulations governing import/export of pharmaceutical products between USA and Europe.
  • Knowledge of ERP/MRP computerized control systems, inventory control methods, and distribution standard operating procedures.

Education & Experience:

  • BS degree in a relevant technical field. Advanced degree and/or MBA with a focus on logistics and supply chain management a plus.
  • Minimum 15 years of experience in supply chain and logistics roles in the pharmaceutical industry. At least 10 years of experience in a leadership role in a global pharmaceutical product supply chain and distribution system.  Experience with cold chain distribution, as well as serialization preferred.
  • Ability to travel domestically and internationally to contractor locations, as needed.
Head of Supply Chain: Apply Now

Job Overview

Responsible for cross-functional project management to ensure that projects are delivered on time and within budget.

Responsibilities and Duties

  • In coordination with project team, develop project strategy and plans.
  • Prepare project objectives in conjunction with all relevant stakeholders.
  • Develop and maintain detailed project timelines.
  • Ensure resource availability.
  • Continually track project status and progress.
  • Ensure efficient project execution, delivering projects on-time, within scope, and within budget.
  • Perform risk management to minimize project risks.
  • Manage all stakeholders.
  • Maintain comprehensive project documentation.
  • Develop and maintain high performing project teams.
  • Assess project performance.

Qualifications

  • MSc degree, PhD preferred.
  • At least 10 years’ experience in pharmaceutical industry, with at least 5 years’ experience in project management.
  • Project Management Professional (PMP) certification preferred.
  • Ability to lead multi-disciplinary teams.
  • Excellent written and verbal communication skills.
  • Strong organizational skills including attention to detail and multi-tasking skills.
Project Management: Apply Now