Associate Director Clinical Operations

FLSA Classification : Exempt/Salary

Schedule: 8:00 am – 5:00 pm; Monday - Friday

Department: Clinical Operations

Reports to: Head of Clinical Operations

Supervisory responsibilities: Yes

Location: Fully Remote

Position Summary/objective:

Global Clinical Trial Oversight.

Essential functions:

Main responsibilities of this position will include but are not limited to the following tasks:

• Provide oversight on feasibility analysis, clinical trial site selection, qualification and initiation of new clinical trial sites and contracting with clinical trial sites in USA
• Provides clinical monitoring strategy and oversight in USA
• Maintains expert-level current knowledge of GCP industry trends and “current-thinking”
• Resource planning and onboarding for internal Clinical Research Associates, Clinical Trial Manager and Site Operations Leads in USA
• Ensure appropriate line management and employee development for internal Clinical Research Associates, Clinical Trial Managers and Site Operations Leads in USA
• Provides oversight on all Immatics clinical trial site related activities, incl. clinical monitoring activities and site operations in USA
• Provides oversight of clinical trial site feasibility/selection in USA
• Provides oversight of qualification and initiation of new clinical trial sites in USA
• Ensures quality and adherence to relevant Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with guidelines and ICH GCP.

Competencies:

• Elevated level of individual responsibility & enthusiasm

Work environment:

This position is remote and should be performed in an office setting that simulates the work office environment. This office must be set up in a way that allows for privacy and quiet during work hours, as well as a comfortable chair and desk. This position uses phone, computer, office equipment and supplies on a regular basis. Noise levels should be at a level which would allow for proper communication with other members virtually.

Physical demands:

• Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.
• Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
• Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.
• Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
• Sitting – remaining in a sitting position for at least 50% of the time.
• Standing/Walking - remain on one's feet in an upright position at a workstation.

Travel required: Willingness to travel if necessary for business purposes

Required education and experience:

• Min. Master’s Degree, preferably in life science or nursing; or equivalent
• At least 2 years of working experience as a Clinical Research Associate
• At least 4 years of Clinical Monitoring experience (as Clinical Research Associate and Clinical Trial Manager) in the pharmaceutical / biotechnology industry, preferred in oncology and cell therapy
• 1 - 2 years line management experience Proactively driving high quality and efficiency to meet timelines and milestones
• Main driver of innovation and development in own area
• High degree of flexibility in an environment which is marked by a constant striving for excellence

Preferred education and experience:

• Ability to strategically think within Clinical Operations and beyond
• Proactively drive company standards and global harmonization within the Clinical Operations
• “Think outside the box” attitude and a high degree of flexibility in an environment which is striving for clinical excellence

Work authorization/security clearance requirements:

Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment.

Affirmative Action/EEO statement:

Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical​​​conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or ​expression, veteran status, or any other status protected under federal, state, or local law.”

Other duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description may not cover all duties that take place on a daily basis and may be changed as business needs change. Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.