Director, Clinical
Program Management

(Cell / Gene Therapy)


Job Number:    #0234


Location:      Montgomery County Maryland
Company:    Well established (the late 1990s) biopharmaceutical company

Focus:           Regenerative therapies - cell therapy
Misc:             There are eight key management employees listed at this company and we are responsible for the recruitment of three of them



POSITION SUMMARY                             

The Director, CPM will be responsible for supporting the Sr. Director, Clinical Operations to ensure all trial deliverables are met according to timelines, budget, operational procedures, and quality standards


Essential Duties & Responsibilities

  • Accountable for successful execution of clinical trials including feasibility, start-up, conduct, close-out, reporting, archiving, etc.

  • Establish and execute high quality, integrated cross-functional project plan for the program to deliver study milestones according to plan

  • Manage & track study timelines and key milestones; ensure transmittal of project/study metrics to Senior Management

  • Manage development team to implement operational strategy; oversee deliverables to support program objectives; identify risks, develop risk mitigation plans; escalate risks and risk mitigation as appropriate

  • Provide study oversight, including data monitoring (flow of data from sites, CRF completion, ensuring data entry in database, data listings, etc.)

  • Provide budget oversight for program activities and lead the development team to deliver project on time & within budget, adhering to required standards of quality & compliance

  • Collaborate with Sr. Director of Clinical Operations in oversight of CRO selection, management of activities and budget, including resolution of arising issues to ensure high-quality CRO service

  • Collaborate with development team to ensure effective communication with CRO(s), clinical sites and regulatory authorities for the program

  • Carefully manage relationships with responsible individuals at trial sites

  • Oversee and organize study meetings as applicable; ensure meeting minutes are finalized and filed

  • Accountable for the quality & accuracy of the development plan

  • Responsible for implementing the operational plan within the development team

  • Line management responsibilities for direct reports (e.g., goal setting, performance evaluation, professional development, etc.)

  • Keep current with industry trends to ensure best industry practices and high- quality project management

  • Assist with resource allocation

  • Assist with training/ mentoring of junior staff, as applicable

  • Help drive continuous improvement initiatives for clinical development

  • Develop and maintain Project Plan including risk mitigation and quality control as appropriate

  • Oversee the writing of key program-related/study-related documents (INDs, protocols, abstracts, presentations, CSRs, regulatory responses, NDAs) and SOPs

  • Provide guidance and motivate project team members to work collaboratively toward Department and Corporate goals/ objectives

  • Oversee development of annual/ quarterly goals, monitor ongoing performance and identify areas to strengthen as appropriate

  • Other duties are assigned and needed

Education & Experience

  • Master’s degree in science or related field

  • At least 12 years of Clinical Operations/Affairs experience

  • At least 5 years of management experience

  • Intermediate knowledge of principles of trial budgeting

  • Knowledge of 21CFR parts 312 (Investigational New Drug Application); 50 (Protection of Human Subjects) and 56 (Institutional Review Boards) and ICH E6 GCP

  • Computer skills which would include proficiency in Microsoft Office and Internet Explorer

  • Excellent written and verbal communication skills

  • PMP certification preferred



Links to Other Job Descriptions 

Sr. Clinical Research Associate
VP of Research & Development

Director/Sr. Director of Regulatory Affairs
Director/Sr. Director of Research & Development

VP of Regulatory Affairs

Clinical Trials Coordinator




Should you elect to send your resume to us, we will never forward it to anyone without first contacting you and receiving your approval to do so.


NOTE:   This is an unofficial document prepared by S L Collins Associates, Inc. to provide basic information concerning the position.   The company we are conducting this search for has the official job description.


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