The Company:

It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You’ll find that rare opportunity at PharmaEssentia. Join us, and let’s transform lives, together.

PharmaEssentia Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one approved product and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking.

Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taipei Exchange (TPEx: 6446) and are expanding our global presence with operations in the U.S., Japan, China and Korea, along with a world-class biologics production facility in Taichung. 

Position Overview:

The Director, Clinical Operations is a key contributor to the company’s clinical development programs and is primarily responsible for directing the planning and execution of global clinical studies in order to successfully move programs through the clinical research process in a timely and quality manner and in adherence with GCP, appropriate SOP’s and appropriate government regulations. This position will work closely with Trial Monitoring, Program Management, Medical, Commercial and Financial Operations in the creation and management of the clinical development plans, driving the planning activities to ensure successful execution and completion of the clinical trial(s).

Essential Duties and Responsibilities:

Will lead the clinical trials implementation and have oversight of clinical trial CROs and clinical laboratory vendors and supervise the Clinical Trial Leaders. Represents Clinical Operations at Program Management team meetings and collaborates with Clinical Research and Medical.

Job duties include, but are not limited to, the following:

• Development and maintain effective Clinical Study Teams, as needed, overseeing deliverables to support program objectives as defined and approved; identify risks, develop risk mitigation plans, and escalate risk mitigation strategies to the VP, Clinical Operations as appropriate.
• Evaluates and determines specific resources needed in the conduct of clinical trials and determines current sourcing strategy.
• Directs progress of trials, study scope, timelines, and resources within defined and approved parameters through clinical study teams.
• Identification and management of Clinical Research Organization(s) and other contractors as needed.
• Provides strategic planning for site selection, contract negotiations and patient recruitment programs.
• Conducts protocol feasibility analysis, country assessment, site identification, and patient recruitment planning.
• Identify investigative sites and provide assistance to facilitate timely selection of investigators and sites.
• Recruitment of patients and manage logistics for getting patients to sites for clinical trials globally.
• Directs the preparation and review of required documentation for the conduct of the global clinical trial(s).
• Interact with investigators as warranted to obtain necessary documentation and information before, during and after the study.
• Ensure accurate inventory of central, investigator site and core files on an ongoing basis to ensure that the files are complete and can be used as a source of reference.
• Ensures that SOPs are current and complete.
• Assist with the preparation and presentation at investigator meetings as required to ensure that the clinical and investigational site staff team is well informed about the study and related procedures.
• Represents Clinical Operations in presentations to Senior Management
• Provides oversight and support to Clinical Study Teams and assigned Clinical Trial Leaders through coaching, mentoring, supervising and providing developing/training opportunities for the staff who are involved in Clinical Operations.
• Responsible for creating clinical policies and procedures to provide strong and efficient clinical trial management, including working with other departments for shared responsibilities.
• Responsible for determining staffing needs for management of clinical trials, including personnel requisitions, and hiring and assigning of staff, contract staff, and CRO support.
• Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
• Responsible for observing all Company, Health, Safety and Environmental guidelines.

Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.

Required:

• Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and clinical trials guidelines and basic understanding of the phases of clinical development is required. Familiarity with the drug approval process through NDA is required.
• Proven track record of successfully delivering projects on time, to budget and the required quality.
• Excellent interpersonal, verbal and written communication skills (including experience in making presentations).
• High degree of customer focus for both internal and external customers and proven ability to build and maintain effective internal and external relationship.
• Leadership and interpersonal skills are a necessity. Must be able to facilitate and work in a team environment.
• Demonstrated ability to effectively negotiate business terms and financial cost.
• Requires computer literacy in several software packages, especially Microsoft Office applications and database software.
• Educated to degree level (biological science, medicine, pharmacy, or other health related discipline preferred) or equivalent nursing qualification/experience.
• Minimum 10 years of industry experience within clinical research/operations. Strong knowledge of Clinical Development, Site Monitoring, Contract Management, Project, and functional outsourcing management.
• Previous supervisory experience required.
• Experience managing global clinical trials.
• Strong meeting facilitation and decision-making skills.

Benefits of working with our team:

PharmaEssentia USA strives every day to improve the lives of patients as well as our employees.

As a valued member of PharmaEssentia USA, you will enjoy the following benefits:

• Comprehensive medical coverage
• Dental and vision coverage
• Generous paid time-off
• 401(k) retirement plan with competitive company match
• Medical & Dependent Care Flexible Spending Account
• Up to $100 monthly cell phone allowance
• Employee Assistance Program

EEO Statement:

At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.

PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies.