Associate Medical Coding Director (Biotechnology Oncology)

SUMMARY/JOB PURPOSE:

The Associate Medical Coding Director is responsible for the delivery of timely and quality coding deliverables for clinical trials and programs. This position develops and implements a long-term coding strategy to ensure that Exelixis meets industry and regulatory requirements for clinical trial coding. The Associate Medical Coding Director manages and oversees Exelixis staff, strategic partners, and vendors who conduct coding activities. They are responsible for conducting oversight of Data Management Coding activities at the portfolio, as performed by Exelixis coding specialists, CROs, or other 3rd Party Vendors, to ensure they meet deliverables per study timelines and comply with Exelixis coding conventions and procedures.

*** This role is an onsite role that can be either located in Alameda, CA or King of Prussia, PA

Essential Duties And Responsibilities:

• Provides and enables solutions for complex problem solving that align with the Exelixis values.
• Establishes Program(s) or Portfolio level dictionary coding strategies and is accountable for the management of vendor partnerships to maximize effectiveness and maintain budgets.
• Leads clinical trial coding deliverables and activities that support Exelixis regulatory commitments including submission of safety data
• Provides coding expertise and capability in support of global development programs
• Serves as a medical coding subject matter expert within Exelixis
• Partners with stakeholders including CDM Systems and Digital Transformation to optimize technology that supports efficient dictionary management processes and with Global Patient Safety and Clinical Development for oversight of vendor coding quality.
• Develops and maintains Exelixis coding conventions to ensure consistency across studies and programs
• Reviews program and study-level clinical trials, serious adverse events (SAE), concomitant medications, and other relevant coded data performed by vendors for quality and consistency.

Supervisory Responsibilities:

None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree with related health science background (e.g. Nursing, Pharmacy) and a minimum of 11 years of related experience; or,
• MS/MA degree with related health science background (e.g. Nursing, Pharmacy) and a minimum of 9 years of related experience; or,
• PhD in related discipline and a minimum of 5 years of related experience, or;
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

• 10+ years of related experience and/or combination of experience and education/training.
• 10+ years of pharmaceutical/biotechnology/CRO in Medical Dictionary Coding, Clinical Data Management and project management.
• Advanced knowledge of ICH-GCP guidelines and applicable drug development regulations.
• Strong understanding of drug development and clinical trial execution, including other required functional areas involved in clinical trials.

Knowledge/Skills:

• Must have a strong understanding and utilization of medical terminology.
• Experience in coding medical data (adverse events and concomitant medications) and understanding of the clinical coding process is required. Working knowledge of MedDRA, and WHODrug is strongly required.
• Developing and maintaining dictionary management processes and synonym lists.
• Experience with Clinical trial data systems and/or EDC coding tools is required with Medidata Coder experience preferred.
• Ability to prioritize and multi-task successfully in a fast-paced and changing environment
• Excellent interpersonal and communication skills, both written and oral, including ability to develop strong relationships with internal and external stakeholders.
• Excellent organizational skills with strong attention to detail; proven ability to handle multiple tasks efficiently, effectively, and timely.
• Demonstrated ability to think strategically across the organization.
• Self-motivated, calm under pressure and adaptable to a dynamic environment with the ability to support successful change.
• Must be detailoriented with the ability to handle multiple projects and priorities
• Demonstrates effective interpersonal and communication skills.
• Ability to contribute to the definition and timely achievement of area projects and goals and serve as a representative for Coding on cross functional projects.
• Problem solving skills should involve identification of problems and proper escalation
• Must be able to work independently as well as in a team environment and effectively collaborate with stakeholders for effective outcomes.

JOB COMPLEXITY:

• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.

• Creates formal networks involving coordination among groups.

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.