Director/Associate Director Clinical Operations

Job#: 1374507

Job Description:

Director, Clinical Operations 1374507

Location: Needham, MA (Onsite)

Therapeutic Areas: Immunology

Job Overview: 

Working closely with an experienced VP Clinical Operations Leader to drive early phase programs forward.

Responsibilities:

• Provide operational and implementation expertise to Clinical Operations trial team(s) to enable timely progression of clinical development programs
• Function as Clinical Operations lead for clinical development program(s) ensuring successful planning, implementation and conduct of all assigned clinical trials
• Work with the cross-functional project team to identify and evaluate issues in the program and suggest and implement solutions
• Provide oversight for development of trial-specific documents (e.g., informed consent forms, study plans/guidelines, operation manuals & training materials)

Qualifications:

• BA/BS in a scientific field of study with a minimum of 8 years of relevant experience working in in the pharmaceutical/ biotech industry, including at least 4 years of clinical trial management experience and full trial life-cycle experience (e.g., start up to closeout)
• Multi-dimensional Clinical operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning etc.
• In-depth understanding of industry standards and applicable guidelines including FDA regulations and ICH GCP guidelines
• Experience in developing Clinical Operations SOPs and trial metrics
• Proven team leadership experience with the desire and ability to work in a fast-paced, matrixed, start-up environment

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

[email protected]

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.