Asahi Kasei Pharma America (AKP America) is actively hiring new employees in the Boston area to support its product development efforts for ART123. AKP America offers a competitive salary and benefits, a stimulating environment that values teamwork, and the opportunity and expectation for individual excellence.
Asahi Kasei Pharma America Corporation is an Equal Opportunity Employer. Pre-employment background check and drug testing required.
Asahi Kasei Pharma America (AKPA) is recruiting for a Contracts Associate. This newly created role offers the qualified candidate an opportunity to contribute to overall success and efficiency of the Alliance Management function within AKPA.
The Contracts Associate will be responsible for updating and maintaining contracts within our contracts tracking system as well as following up on the status of contracts under negotiation between parties. He/she will also manage the internal signature control process in addition to preparing and troubleshooting global investigator payment reports.
This position operates in an environment that demands strong attention to detail, as well as strong organization, prioritization and problem solving skills. A basic understanding of the clinical contracting process with sites and vendors is also required.
The Contracts Associate will work closely with the Manager of Clinical Contracts and our Director of Alliance Management on a day to day basis and will work with varying levels of independence on special projects/requests as appropriate. To succeed in this role, you must have the ability to prepare and analyze detailed financial reports. You will assist in the review of contracted budget assumptions vs. actuals expenditures troubleshoot invoices, and follow up directly with clinical sites and/or vendors to ensure accurate and timely payment. A strong professional presence along with a high level of professional maturity is required as you will interact with company senior management, principal investigators and vendors.
Experience and Qualifications
- Minimum of 2 years’ experience in a clinical research/pharmaceutical environment in a budgeting, finance or contracts management function.
- Bachelor’s Degree required. Business, finance or science focus preferred.
- Experience with Clinical Trial Management System is highly desirable.
- Able to work constructively in a matrix environment.
- Self-motivated, pro-active with strong technical skills in all MS Office Suite programs.
Senior Medical Director
Asahi Kasei Pharma America is recruiting for a Senior Medical Director, based in our Waltham, MA corporate office, to support ongoing clinical development programs related to our Phase III trial. Reporting to the Vice President, Medical Affairs, this is a key leadership role and the qualified candidate will work in close collaboration with Medical Affairs, Clinical Operations, Safety & Pharmacovigilance, and Regulatory Affairs.
As a Senior Medical Director you will be involved in authoring protocols, investigator brochures, informed consent documents, responses to questions from regulatory agencies, institutional review boards and ethics committees, and clinical study reports. The role also involves safety monitoring as well as oversight of clinical sites for adherence to both company standards, and government/industry regulations (GCP/ICH).
To be considered you must possess:
- MD. degree from an accredited college or university. Prefer at least 3 years progressive experience in Pharmaceutical or Biotech industry, working in Medical Affairs and/or clinical research and development or related fields.
- Experience in or knowledge about drug-development procedures.
- Industry/academic experience in planning, executing and reporting clinical trials is preferred. Strong understanding of clinical trials process with demonstrated ability to have designed and implemented programs and initiatives directed towards defined strategic objectives is also preferred.
- Strong leadership skills
- Strong understanding of GCP/ICH, FDA and EMA approval process
Senior Clinical Research Associate
Asahi-Kasei Pharma America (AKPA) is looking to hire a Senior Clinical Research Associate based in a Western US home office. This is a tremendous opportunity for a seasoned CRA to enhance our success by utilizing diverse professional skills in identifying, selecting, initiating, monitoring and closing-out investigational sites for our clinical studies. We are looking to identify and hire a high-energy individual interested in having an immediate impact on current and future study activity. This is a high-visibility role that, based on the impact that you have, can put your career on the “fast-track” in a growing, dynamic clinical operations group.
- Key responsibility includes management and monitoring sites in accordance with our Clinical Monitoring Plan, applicable SOPs and ICH/GCP:
- Perform Pre Study Site Visits (PSSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close Out Visits (COV).
- Perform 100% SDV of data, verify documentation and timely reporting of ICF, AEs and SAEs, laboratory sample collection and distribution, eCRFs including resolution of queries, ensure proper storage, dispensation and accountability of the investigational product
- Provide site updates/communicate study issues/escalate serious or outstanding issues to Clinical Project Manager
- Work with project management team to:
- Assist with study start up, study maintenance and study close-out activities
- Attend and present at Investigator Meeting(s) and/or Study Coordinator Meetings
- At least 5 years of CRA experience with all aspects of clinical monitoring (start up to close out and site management) of acute care clinical trials required. ICU/CCU/SICU experience as well as Phase 3 clinical trial experience with intravenous products is preferred.
- Bachelor degree preferably in a clinical, science or health-related field (nursing, pharmacy and medical technology preferred) or relevant clinical experience
- In-depth understanding and proficiency in ICH / GCP, FDA and local regulations is an absolute requirement
- Excellent written and verbal communication skills, interpersonal skills and organizational skills
- Must have a valid driver’s license and be willing to travel up to 50% within North America
Asahi Kasei Pharma America (AKP America) does not accept unsolicited resumes from any third-party recruiters, agencies or individuals. Any such third party recruiters, agencies or individuals seeking to work with AKP America must first contact the staffing group at firstname.lastname@example.org. Only approved staffing vendors will be allowed to provide services to AKP America. Unsolicited resumes will be deemed the property of AKP America to follow up with as it sees applicable and no fee will be paid in the event the candidate is hired as a result of the referral or by other means. Submission of unsolicited resumes does not create any implied obligation on the part of AKP America.