Position Summary:

The Senior Director, Clinical Operations, Biospecimen Solutions will provide leadership, strategic oversight and guidance to all of Precision for Medicine Biospecimen Solutions Clinical Operations to ensure advancement of the goals and objectives of the service line. This role is based 3 days in the office at Norton, Ma and 2 remote.

 

Essential functions of the job include but are not limited to:

  • Works collaboratively with the relevant stakeholders of Precision for Medicine Biospecimen Solutions team to ensure the service line maintains an extensive and comprehensive supply network for all products and services for the Biospecimen Solutions service line
  • Manages, leads, and supervises clinical operations team
  • Develops, manages, and achieves annual goals, objectives, and revenue targets for the division in collaboration with other members of Biospecimen Solutions team
  • Articulates the vision of the division to all clinical operations staff
  • Regularly assesses operating results of programs against established objectives and implements appropriate measures to correct unsatisfactory results
  • Evaluates the results of overall operations regularly and systematically and reports these results through internal dashboard reports and other industry standard metrics
  • Coordinates with accounting/finance departments and the organization’s revenue cycle department to ensure that clinical and administrative functions are in place to adequately document and collect earned income
  • Ensures compliance with accrediting, licensing, and regulatory bodies through established QA/QC departments and staff
  • Ensures that all clinical operations are carried out in compliance with all applicable local, state and federal laws and regulations through established QA/QC departments and staff
  • Negotiates and executes contracts with physicians, independent contractors, research sites, labs and other professionals and ancillary organizations in order to achieve division objectives and goals
  • Responsible for strategic expansion, improvement, and new program creation/integration to leverage opportunities in the Biospecimen market
  • Evaluates general economic, business, and financial conditions and their impact on clinical operations, and identifies solutions where problems exist
  • Maintains the organizational structure and processes necessary to manage the organization’s current activities and its projected growth. Influences organizational change and efficiency as necessary to facilitate strategic initiatives and planned growth
  • Evaluates opportunities for efficiencies, centralization, and standardization within clinical operations with resulting implementation of efforts to promote such goals followed by regular assessment and re-tooling for maximum impact
  • Ensures ongoing collaboration and networking with appropriate partners, other health care providers/entities to promote Precision for Medicine Biospecimen Solutions as an essential partner and to establish referral relationships as needed
  • Ensures exemplary and consistent revenue, increased number of qualified/competent collection sites and increased number or scope of collections/requests/protocols from collaborative partners (sponsors) in the biotech/pharma/diagnostics industry
  • Ensures consistent evaluation of customer feedback and collaborates with the General Manager or Partner Experience Manager to implement activities to enhance the customer experience (site and sponsor)
  • Collaborates with operations team to ensure staff training programs are designed and implemented to equip staff with the knowledge necessary to perform their jobs effectively, efficiently and safely, to ensure adequate management development, and to provide for capable management succession
  • Partners with Human Resources and General Manager to promote creative and effective staff recruitment and retention activities to ensure that the organization is attracting and retaining motivated, energetic, dedicated staff at all levels
  • Actively participates in monthly Leadership Team and Management meetings
  • Develops and implement policies and procedures
  • Promotes, champions and facilitates integration, collaboration and teamwork between all departments throughout the organization to advance overall plans and initiatives
  • Represents Clinical Operations to internal and external constituencies, including other agencies’ committees and work teams, professional conferences, tradeshows, and other venues and partners as needed
  • May serve as a member of quality and risk management and compliance committees
  • Ensures a culture that embraces diversity, fair and ethical treatment of all persons, and customer-focused delivery throughout the organization
  • Oversee a portfolio of multiple collaborative projects involving the prospective and retrospective collections, labs, and other ancillary operations
  • Be available and willing to spend ~25% time or more as needed traveling for speaking, recruiting, training, sales and other partnership or business cultivation activities
  • Investigates, monitors and communicates with direct reports and Business Development team on new and potential sources of Biospecimen opportunities in support of new, existing, planned and contemplated programs and conducts integral feasibility assessment and proper project scoping
  • Investigates, implements expands Biospecimen Solution’s electronic and technical platforms to increase efficiency, compliance and quality
  • Creates and develops concepts for “direct-to-consumer” expansion of clinical research opportunities, including e-consent, and self-collect specimen initiatives
  • Creates and develops policies and procedures for virtual subject enrollment and strategic recruiting via social media to reach potential subjects (disease state and healthy normal) via social media platforms, and develops associated master, proprietary registry capable of transmitting e-communication blasts to facilitate rapid enrollment in our studies
  • Creates and develops appropriate Real-World Experience/Real World Data with collaborative sponsors to provide supplemental data related to new product development to enhance FDA submissions per 21st Century Cures Act or other regulatory/statutory requirements
  • Seeks out, identifies and increases the database of appropriate research sites based on enhanced/ongoing feasibility assessments and partner Biospecimen needs
  • Actively collaborates with Precision for Medicine’s established biobanking team to predictively and prospectively collect specimens and bank in appropriate storage conditions in anticipation of market increases for specific collection requests
  • Collaborate with Marketing to increase branding efforts and positive subject/partner impressions
  • Build, maintain and sustain intricate relationships with Clinical supply networks, sites, sponsors, CROs, labs, professional organizations, industry leaders, contractors, academia, activist organizations and others in order to cement Biospecimen Solution’s position as industry leader
  • Create and facilitate other strategic initiatives as needed to increase and enhance Biospecimen Solutions business model

 

Qualifications:

 

Minimum Required:

·         Bachelor's degree (B.S.) from four-year college or university; preferably with a focus in Nursing 

  • 10+ years directly managing multidisciplinary teams in clinical research, lab, or other healthcare systems directly related to Biospecimens or Clinical Research

 

Other Required:

  • Clinical Research Certification from an accredited organization (SOCRA, ACRP)
  • Project management skills and training
  • Ability to read, analyze and interpret general business periodicals, medical and professional journals, technical procedures, and governmental regulations
  • Ability to write reports, business correspondence, and procedure manuals
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, Board members, and the general public
  • Ability to apply advanced mathematical concepts
  • Ability to define problems, collect data, establish facts and draw valid conclusions
  • Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables
  • Good working knowledge of computer software (Microsoft Office applications)
  • The employee is frequently required to sit and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must frequently lift and/ or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.  Specific vision abilities required by this job include close vision, distance vision, depth perception and ability to adjust focus
  • Must be able to read, write, speak fluently and comprehend the English language

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