Clinical Operations

Location
Cambridge, MA
Posted
Jun 24, 2022
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Contract
Sr. Manager/Associate Director

Clinical Operations

Location: Cambridge, MA  

Hybrid: Yes

 

General Summary

Orum Therapeutics is seeking to expand our in-house Clinical Operations Team with the addition of a Clinical Operations Leader (COL).  The COL will be responsible for providing strategic leadership to the Clinical Operations team to ensure the successful operational execution of clinical trials of assigned portfolio assets.  The successful candidate will be an experienced hands-on leader that will serve as a subject matter clinical operations expert for Orum’s Clinical Operations team.  The COL will be responsible for the design, plan and execution of clinical studies and the delivery of quality data through all clinical trial phases in compliance with ethical and regulatory requirements, within timelines and budget and in accordance with company SOPs, GCP and ICH guidelines.  In addition, the COL will work collaboratively with other functional leaders within Orum to improve the effectiveness and efficiency of processes and procedures supporting clinical trials.  Strong project management is required to ensure the studies are carried out in accordance with the appropriate quality standards, including ICH/GCP, and applicable regulations on time and within the agreed budgets.

 

Principle Duties and Responsibilities

·         Provide operational and clinical expertise and strategic insights to develop a life-cycle strategy and evaluation of new programs to be prioritized or advanced into clinical development.

·         Manage ongoing trials being undertaken on behalf of 3rd Party Vendors, delivering the Clinical Development objectives, and achieving clinical excellence through coordination of a multi-disciplinary team and Clinical Research Organizations (CROs).

·         Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines for assigned projects, ensuring they are performed to the most rigorous standards of quality, within the agreed timeframes and budget.

·         Act as primary contact for the vendor, monitoring performance, identifying issues, and overseeing and co-ordination of corrective actions.

·         Chair internal and external meetings related to assigned clinical studies.

·         Implement a strong quality culture within Clinical Operations ensuring all clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/ policies and industry best practices.

·         Responsible to ensure clinical trials are conducted in compliance with applicable regulatory requirements and are inspection ready.

·         Ensure that the necessary regulatory, safety and data evaluation requirements are met to allow the conduct of clinical related actives in conjunction with the regulatory and pharmacovigilance processes. 

·         Lead initiatives to build clinical department infrastructure and to improve efficiency and effectiveness of processes and procedures. 

·         Contributes to development of SOPs.

·         Foster and develop a team approach to all activities associated with the implementation of clinical studies.

Skills, Abilities & Competencies

·         The successful candidate will be an innovative and collaborative individual who thrives in a “get it done” type of environment with diverse clinical operations experience and the following mix of personal and professional characteristics:

·         10+ years’ experience of Clinical Operations experience at biotechnology, pharmaceutical or CRO, with a focus on Oncology studies

·         Must have proven experience in CRO oversight, vendor selection & contract negotiation

·         Pre-clinical to Ph III experience with a particular focus on Phase I & II global clinical trials

·         Excellent leadership and interpersonal skills; ability to collaborate across disciplines with demonstrated ability to effectively lead multi-disciplinary global teams

·         Experience working with Antibody Drug Conjugates (ADCs) will be a plus

·         Budget & financial management

·         Strong organizational and time management skills. Ability to organize and prioritize to meet deadlines in an unknown environment with competing priorities.

·         Excellent oral and written communication skills, auditing skills, and proven ability to work autonomously and effectively in a teal organizational environment.

Education-   Minimum B.A./B.S. degree in science/healthcare field. MS preferred.

Orum offers a Core benefits program which includes: medical, dental, short and long term disability, life insurance and a 401k.

*U.S. citizens and those authorized to work in the U.S. (green card) are encouraged to apply. We are unable to sponsor at this time.

*Candidate must be able to pass a background investigation.

*Unable to work with 3rd party candidates or agencies.

 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Orum Therapeutics is an Equal Opportunity Employer (EOE).