Careers

Summary

The Clinical Project Manager is a key member of our Clinical Team and is responsible for the feasibility, selection, set up, conduct and closure of clinical trials according to the study plans. The Clinical Project Manager handles the operational management of clinical studies, ensuring compliance with the study procedures, timelines, milestones and budget.

The Clinical Project Manager also acts as the main line of communication to relevant stakeholders and provides input on feasibility, study design, budget development and ensures progress reporting (resources, budget and timelines). Acts as monitoring team(s) leader in the designated territory for the trial and ensures the team is trained properly.

Essential Duties and Responsibilities

• Participates in and handles the feasibility, selection, set up, conduct and closure of clinical trials within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Standard Operating Procedures. 
• Manges operational tasks associated with clinical studies, ensuring the compliance with timelines, milestones and budget.
• Creates and implements study-specific clinical monitoring tools and documents.
• Identifies, enlists and selects sites, and coordinates site management activities.
• Arranges and oversees site visits.
• Gathers and examines trial documents.
• Provides input on study related documents (e.g. ICF, CRF, monitor plan, protocol, study Procedure Manual etc.), set-up and maintains study files.
• Other duties may be assigned.

Supervisory Responsibilities

This job involved managing field CRAs.

Competencies

• Team Work
• Professionalism
• Judgement
• Ethics
• Interpersonal
• Project Management

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be willing and able to travel 50% of the time and has high energy levels.

Education and/or Experience Required

• Degree in medicine, health care, life sciences or related fields.
• Minimum of 5 years of experience in clinical research.
• Knowledge of clinical trial design and development.
• Experience with coordinating and leading a team.
• In-depth knowledge of ICH-GCP, local legislation and procedures.
• Excellent organization and management skills.
• Good negotiation and communication skills.
• Results oriented.
• Fluent in English and in the country's native language.

Computer Skills

Microsoft Word, Excel and PowerPoint.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 10 pounds.  

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

The Director of Financial Planning and Analysis leads the Company FP&A and reporting process while building strategic finance initiatives and business reviews. Responsible for strategic planning, budgeting and related systems as well as researching and analyzing financial information to help the Company make informed decisions, develop and improve financial processes and monitor financial movements.  Engages in broad strategic dialog with Management to drive the growth of the Company.

Essential Duties and Responsibilities

• Serves as a financial and business partner to the Company.
• Contributes actively to the evolution and execution of the Company’s strategic and operational plans, maximizing opportunities to accelerate revenue growth while controlling profitability.
• Builds and manages the financial and information technology functions including, financial reporting, strategic planning, product profitability, cash and working capital management.
• Manages the Company’s cash flow and works with CFO to address capital needs.
• Prepares business plans and operating results for the Board of Directors.
• Develops long-term, trusted relationships and credibility with key external partners including external auditors, banking relationships and other advisors.
• Actively participates in M&A opportunities, including financial due diligence and integration of potential acquisition targets.
• Provides leadership, mentorship and coaching to the accounting and finance team that fosters an environment of problem solving, collaboration, efficiency, improved business practices and attracts and retains talent in a growing and ever-changing environment.
• Develops, implements and ensures GAAP compliance with financial and accounting policies, procedures and related systems and internal controls. 
• Other duties may be assigned.

Supervisory Responsibilities

This position is currently a sole contributor but it is anticipated that this role will build out the FP&A team to support the business growth objectives.

Competencies

• Agile.
• Strategic Thinker.
• Leadership.
• Written and Verbal Communication Skills.
• Technically Savvy.
• Problem Solving.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Must be self-motivated, results orientated, have the ability to organize/manage multiple tasks and be a critical thinker.
• Superior communication skills with the ability to communicate complex issues in a crisp, clear and concise way is ideal.
• Ability to identify problems, formulate solutions, influence others, and drive results are important leadership skills for this role.
• Technical experience establishing financial systems and infrastructure to enable scale.
• Ethical Conduct. 
• This position requires up to 10% travel (may include minimal international travel). 

Education and/or Experience Required

Required

• MBA in Finance, accounting or related field
• A minimum of 10 years of progressively responsible financial leadership experience

Preferred

• CPA or other additional relevant advanced degree(s) and/or certification(s).
• M&A Experience
• Previously held Finance roles within the pharmaceutical industry and exposure to Gross To Net challenges.

Language Skills

Superior communication skills with the ability to communicate complex issues in a crisp, clear and concise way is ideal.

Computer Skills

• Technical software skills and experience
• Experience establishing financial systems and infrastructure to enable scale, including ERP systems, Business Intelligence Tools and experience optimizing data analytics to enact business decisions.

Physical Demands

While performing the duties of this Job, the employee is regularly required to sit. The employee is frequently required to talk or hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds. 

Work Environment

The noise level in the work environment is usually moderate. 

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

The Senior Director/V.P. of Clinical Operations position will be responsible for the leadership and oversight of clinical study operations by organizing and coordinating the planning, implementation, management, execution and completion of clinical programs according to applicable FDA and EU regulations and guidance, ICH and GCP, for biosimilar products. This position will also be responsible for the development of clinical systems/processes and effective communication within and outside the corporation related to the implementation of processes and successful completion of studies.

Essential Duties and Responsibilities

• Manages the development process for clinical systems and critical study documents, including.
• Supports clinical studies activities with regard to protocol development, data collection, data analysis and reporting requirements, to include but not limited to: Post market study reports, US FDA Supplements, Progress Reports, and other required reports (e.g., site enrollment); European Union notified body clinical study interim and final reports in support of CE mark activities; adverse event reporting to quality assurance, as appropriate; local Ethics Committee and Institutional Review Board (IRB) submissions as they relate to regulatory requirements during the course of clinical trials.
• Determines study objectives, strategy, scope and schedule in order to meet business needs.
• Develops study materials, including investigator’s brochures, regulatory binders, and case report forms.
• Oversees data management activities (e.g. creation of CRFs, CRF completion guides, data management plan, monitoring plan, actual monitoring data validation).
• Interfaces with statisticians regarding analysis plans, report tables, audits and logic checks.
• Oversees maintenance of all clinical (site) files.
• Interfaces with central IRB(s).
• Creates clinical SOPs and guidelines as necessary, and is responsible for ensuring compliance.
• Selects, interfaces with, and assures training of investigators and clinical staff.
• Ensures adequate monitoring is conducted on all clinical trials.
• Enlists support and specifies tasks for various clinical team members to assure meeting study objectives/schedule.
• Communicates study progress site and company personnel on a regular basis.
• Evaluates clinical data/information, providing interim and final reports, convening and directing investigator conferences to review findings and provide advice on direction.
• Provides input and support for planning post-clinical activities and market launch of products.
• Develops and manages budgets for assigned studies, including allocating payments to sites for CRF completion and for study activities/procedures (if applicable).
• Controls clinical product distribution and allocation.
• Other duties may be assigned.

Supervisory Responsibilities

It is anticipated that this position will involve managing clinical trial managers and field CROs/CRAs.

Competencies

• Team Work
• Professionalism
• Judgement
• Ethics
• Interpersonal
• Project Management

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be willing and able to travel 35% of the time and has high energy levels.

Education and/or Experience Required

• Degree in medicine, health care, life sciences or related fields.
• Minimum of 5 years of experience in clinical research.
• Knowledge of clinical trial design and development.
• Experience with coordinating and leading a team.
• In-depth knowledge of ICH-GCP, local legislation and procedures.
• Excellent organization and management skills.
• Good negotiation and communication skills.
• Results oriented.

Language Skills

• Fluent in English and in the country's native language.

Computer Skills

• Microsoft Word, Excel and PowerPoint

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 10 pounds.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.