Assistant Director, Clinical Operations

Ionis Pharmaceuticals, Inc.

Posted: April 4, 2016

Job ID: 147

Job Summary

Term: Full-Time
Required Education: Bachelor’s Degree
Required Experience: 4+ years
Compensation: DOQ

Job Description

Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat complex and challenging diseases. We are the pioneer in the discovery and development of antisense drugs with more than 1300 patents.

Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our founding goals have changed little in over 27 years and our success is a direct result of our outstanding employees. We are interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.

ASSISTANT DIRECTOR, CLINICAL OPERATIONS

The Assistant Director, Clinical Operations is accountable for providing strategic and tactical leadership to one or more clinical programs under the sub-title Clinical Program Leader. The Assistant Director ensures successful execution of protocols within the program; achieving quality, timely completion, and on target spending with established budgets. Additionally, the Assistant Director assumes functional management of Clinical Operations team members; ensuring successful development of skills and talents for the benefit of the organization.

RESPONSIBILITIES:

Oversees one or more programs simultaneously, ensuring the following: trials are executed within timelines and budget forecasts, operational issues across protocols are identified and resolved expeditiously, implementation of standards across studies are seamless
Provides strategic and tactical guidance in risk management
Provides guidance on the development and implementation of clinical protocols within the program
Engages in partnership alliance relationship management, as applicable
Provides framework for contract negotiations and vendor selection
Reviews and approves contracts and vendor selection
Serves as the Clinical Operations representative at the program level
May perform the Clinical Trial Manager (CTM) function on one or more trials as needed and may provide coverage to CTM when necessary
Provides leadership to develop the Clinical Trial Management function as a Center of Excellence
Manages and develops the ongoing performance of one or more Clinical Operations team members, including annual performance evaluations
Creates a positive work environment by encouraging mutual respect, innovation and accountability at all levels
Develops and motivates others through goal-setting, ongoing feedback, formal evaluation, and effective delegation of decision making
Ensures that direct reports are trained and proficient in the incorporation of Ionis Standard Operating Procedures and ICH/GCP guidelines into clinical trial execution
Participates in Quality Assurance efforts
Regularly reports program status, resource requirements and staff performance to the Head of Clinical Operations
Participates in department management meetings to plan and implement operational activities to increase quality, productivity, and efficiency of the Clinical Trial Management functions
Supports and/or leads functional initiatives, as assigned
Assists with development and management of program budgets
Anticipates and meets internal and external customer needs and implements feedback mechanism from customers to ensure needs are met
Ensures optimal relationships with key internal partners and stakeholders to enable successful execution of trials
Maintains clinical trial management expertise through clinical trial literature review, ongoing awareness of industry practices and participation in professional activities
Utilizes appropriate IT systems and ensures that direct reports utilize and update systems and tools to enable successful trial execution

COMPETENCIES IDENTIFIED FOR SUCCESS:

Proven track record with leading teams on high priority projects
Demonstrated ability to identify and execute staff development strategies
Displays a high level of commitment
Ability to anticipate and solve problems proactively
Ability to analyze complex activities and information to arrive at logical conclusions
Ability to think globally and strategically and to execute risk management plans
Effective written and verbal communication skills
Outstanding organizational skills with the ability to multi-task and prioritize
Flexible to an ever-changing environment
Effective delegation skills
Self-motivated and resourceful

EDUCATION, EXPERIENCE, AND OTHER REQUIREMENTS:

Bachelor’s Degree
Minimum of eight years of relevant clinical research experience, including three years in a supervisory role, either as a functional/line manager or co-accountable for performance management within a team matrix, or combination of equivalent experience
Comprehensive knowledge of GCP, ICH and FDA guidelines; sufficient knowledge of Competent Authority regulations in regions outside the US
Demonstrated knowledge in several relevant therapeutic areas
Advanced computer skills in Word, Excel, PowerPoint, and Project
Travel may be required
An ability to be productive and successful in an intense work environment

Excellent salary and benefits package offered.

For more information on Ionis and to apply for this position, please visit our website, www.ionispharma.com.

Reference Requisition #15-0056

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. is proud to be an EEO employer.