1. Contact CJ Prestia
617-448-5707
CJPrestia@Trident-es.com
Principle Consultant/Sr. Consultant
-Regulatory Strategy/Global Program Management/Clinical Development
(Ass. Director/Director level position)
Location: Remote-based role within Central/Eastern US Region
(Close to Hub), & Waltham, MA (Corp. HQ), Periodic visits
to client locations as needed.
Relationships:
Reports To: Principal Consultant/Managing Director
Directly Supervises: Consultants
Provides Work/Direction: Consultants
Works Closely with: Managing Directors, Principle & Consultants, Independent
Consultants, Clients.
External Relationships: Diverse Portfolio of Pharmaceutical, biotechnology, medical
device and life sciences service organizations and
collaborators.
Overview:
To provide best-in-class, high-level, strategic consulting expertise across multiple
functions managing Clinical Development from a Regulatory perspective to clients in the
biotech, pharmaceutical, medical device, & life sciences industry. Partnering with clients
at all levels of corporate structure in order to identify, assess, and implement effective
strategy improvements. Identifying business development opportunities with new and
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2. existing clients. Management of cost-effective resources with both internal & external
resources.
Key Accountabilities:
• Collaborates with the Principal Consultant/Managing Director to understand the
client expectations, internal team organization and roles and responsibilities.
Communicates with assigned team members, and creates and provides
deliverables within the scope of work and/or the engagement plan’s timeline and
budget, ensuring the deliverables meet quality and timeline expectations and are
prepared and received by the client to those expectations.
• Assists Managing Directors and/or Principal Consultants with assessments of the
infrastructure, strategy, structure, product development capabilities, efficiencies
and systems of relevant client organizations. Creates reports with
recommendations for client engagements and obtains input from the remainder of
the team to ensure inclusion of comprehensive findings and recommendations.
• Works directly with the Principal Consultant/Managing Director to design an
approach for fulfilling or expanding engagements as applicable. Contributes to
and understands the scope of the total project. Assists with communicating new
resource requirements and skills needed to expand the project and revises as
necessary through collaboration with Principal Consultant/Managing Director.
• Participates in strategic networking and business development efforts for the
company as defined in personal goals. When new opportunities for business are
identified or defined by client, ensures they are communicated to Principal
Consultant to investigate further.
• Performs ongoing independent assessments as outlined above on new projects
and/or ongoing expansion of relevant client engagements, communicating the
findings to the Principal Consultant/Managing Director, and applying the findings
to the project engagement plan moving forward as applicable.
• Contributes to creation of engagement debriefs/lessons learned with team and
Principal Consultant/Managing Director.
• Deepens trust-based relationships with clients and communicates real or potential
changes in client relationships to Principal Consultant/Managing Director on an
ongoing regular basis.
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3. • Maintains billable time expectations on assigned projects as defined by Principal
Consultant/Managing Director, and proactively communicates changes in
expectations in a timely manner.
Core Skills:
• Client focused approach to work.
• Relevant technical skills in at least two of the following- regulatory, clinical,
program management, quality systems
• Excellent interpersonal, verbal and written communication skills with specific
experience in scientific, medical or technical writing.
• A flexible attitude with respect to work assignments and new skills acquisition.
• Ability to manage multiple and varied tasks and prioritize workload with attention
to detail.
• Willingness to work in a matrix environment and to value the importance of
teamwork.
Education:
• Bachelor's degree in a life science, business, or management.
• Advanced degree preferred.
Language Skills:
• Must be proficient in English.
• Additional language skills a plus.
Work Experience:
• Typically the equivalent of 8-12+ years work experience in a biotech,
pharmaceutical or medical device company, or other area of the healthcare
industry in regulatory affairs/program management/clinical development/quality
systems.
• Experience relevant to assigned practice area(s) at a Director level or above.
• Experience working in an industry based service organization a plus.
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