Deerfield Management Companies

Director/Senior Director, Clinical Operations

Job Locations US-PA-Bala Cynwyd
ID
2018-1035
# of Openings
1

Overview

Chondrial Therapeutics, Inc., is an emerging biotechnology company focused on the treatment of rare mitochondrial diseases. Our mission is to develop therapies for diseases that are rare and where there is an unmet medical need.   We are initially targeting Friedreich’s Ataxia (FA), which is a progressive disease that affects multiple body systems, particularly the brain and heart. FA is the most common ataxia in man and is caused by a deficiency of a key protein, frataxin, which is normally present in the mitochondria of all tissues.  Children and young adults progressively lose the ability to walk and speak, and their hearts become very thick and weak, and can eventually fail. There is currently no cure for FA.

 

Scope of the position

Chondrial is anticipating the Director/Senior Director of Clinical Operations will be a key member of the senior management team.  The position will play an important role in execution of the clinical development of CTI-1601, Chondrial’s lead drug candidate, as well as the clinical development of new pipeline compounds.

Qualifications

  • BS/BA degree required in science/health-related field. A Master’s or doctorate degree is preferred.
  • The candidate should have a minimum of 10 years of clinical research and/or clinical project management experience in domestic and international clinical trials.
  • Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
  • In-depth understanding and experience across the clinical operations value chain, with a track record of success in study planning, execution, data cleaning, database locking, study report generation, regulatory interactions and regulatory inspection.
  • Able to work independently and make appropriate strategic decisions to operationalize and progress clinical trials to completion.
  • Excellent written and oral communication and presentation skills
  • The ability to manage multiple priorities, while maintaining attention to detail is critical.
  • Experience operating effectively within an entrepreneurial start-up small biotechnology environment.
  • Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities.
  • Possesses strong and influential leadership skills with proven ability to lead internal and external team members at all levels to effectively manage people and projects.
  • A results-oriented team player with strong interpersonal and communications skills, capable of working collaboratively with colleagues
  • Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms).

PM18

Responsibilities

The Director/Senior Director of Clinical Operations will be responsible for the following activities:

 

  • Creates, executes, and proactively manages clinical trial processes to facilitates high quality conduct of clinical trials.
  • Oversees and leads cross-functional team resources and external service providers (including clinical operations, medical monitoring, safety, data management, and consultants) to conduct trials on time, on budget, in compliance with Good Clinical Practice, laws and regulatory authority regulations, and conduct trials of the highest quality.
  • Coordinates/executes all operational aspects of clinical studies (including identification and management of vendors, and availability of clinical supplies at the sites).
  • Works collaboratively with cross-functional internal and external teams including regulatory affairs, medical writing and data management, biostatistics, and quality
  • Identifies, qualifies and facilitates audits, and manages all external vendors, including CROs. Takes initiative to continually monitor each external vendor in performance management, escalates issues where appropriate, and makes the appropriate changes in order to ensure trial conduct is completed in compliance and meets Chondrial’s business objectives.
  • Facilitates all start-up activities, including but not limited to investigational site contracts/budgets, and investigational site and IRB/ethics committee submissions.
  • Identifies, qualifies, manages, and maintains relations with clinical trial sites, including collaborating with Principal Investigators and field team on developing robust study protocols, drives site selection process, and coordinates subject recruitment programs to deliver enrollment targets. Performs site monitoring with field team as needed.
  • Ensures clinical trial team and clinical trial sites are properly trained and in compliance with company and/or CRO SOPs, regulatory authority regulations, ICH GCP guidance, and study protocol.
  • Identifies any gaps in company/CRO SOPs and facilitates the development of internal SOPs as needed along with the Chondrial quality team.
  • Represents all aspects of Clinical Operations and provides updates as required to the Senior Management Team, Project Teams, Board of Directors, and other key internal stakeholders.
  • Leads & mentors Clinical operations staff to support successful internal training and its implementation and serves as an advocate for professional development of Clinical Operations staff.
  • Responsible for writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB submissions/approvals, site activations, monitoring plan and tools, CRFs, DMP, edit checks, safety plan, IDMC charter, close-out plans, and CSRs.
  • Assists with the development of presentations, handouts, and coordination of Investigator Meetings.
  • Responsible for ensuring the trial is “audit ready” at all times.
  • Works with appropriate team members to ensure that all TMF-related documentation is current, on-file at respective sites, CRO, and sponsor locations throughout trial conduct. Oversight of final TMF. Notifies and prepares team for regulatory agency audit and addresses any audit observations appropriately and in a timely manner.
  • Performs oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported.
  • Develops key performance indicators to track clinical activity. Proactively monitors and reports trial progress and performance, timelines, and financial metrics on an ongoing basis to management team, including current status of study milestones and forecast of budgetary requirements based on scope of work.  Provides regular updates to vendors and contract staff concerning status and progress of the trial.
  • Accountable for the authorship of operational sections of protocols and investigator brochures.
  • Develops and maintains strong relationships with CROs, external experts and Investigators to ensure effective execution of internal and external clinical projects.
  • Provides clinical support for regulatory submissions, supporting dossier development and participating in interactions with FDA, EMA and other regulatory agencies.

 

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