Sr Director, Clinical Program Optimization
Company: Insmed Incorporated
Location: Bridgewater
Posted on: August 6, 2022
Job Description:
Insmed is a growing global biopharmaceutical company powered by
our purpose to deliver life-altering therapies to small patient
populations experiencing big health problems. Our most valuable
resource is our employees, and a patients-first mentality guides
everything we do. Today, we are building a world-class team of
talented individuals who are willing to challenge the status quo,
solve problems, and work collaboratively and with a sense of
urgency. Come join us if you are ready to roll up your sleeves and
be recognized for your efforts while working alongside team members
who share your passion for serving patients and their
families.Named -Science's -2021 Top EmployerInsmed is dedicated to
creating a collaborative environment where our team can thrive.
Every day, our employees turn their passion for science and
research into innovative solutions for patients. That's why we were
named the No. 1 company to work for in the biopharma industry in
-Science's -2021 Top Employers Survey.A Certified Great Place to
WorkWe believe we have built something truly special at Insmed, and
our employees agree. Each day, we show up for each other and for
the patients we serve. That's why we were recently certified as a
Great Place to Work in the U.S.The Senior Director, Clinical
Program Optimization is responsible for identifying areas of
greatest opportunity to improve clinical trial performance and
increasing consistency, efficiency, and effectiveness across
programs. - This dynamic role requires the ability to analyze
situations, synthesize recommendations, and lead special projects
and cross-functional process improvement initiatives. - The
Individual needs to be able to plan long-term and visualize the
future state while remaining focused and deeply involved in
executing short-term activities to meet planned goals. - The ideal
candidate will have strong foundational knowledge and experience in
Clinical Operations, which can be tapped into to drive his/her
thinking. - The Role will serve as a member of the Development
Operations Leadership Team and participate in setting the strategic
direction for the Department and executing against functional
goals. - -This is a non-supervisory position, but could have
coaching and mentoring responsibilities. - -This role could have
responsibility to oversee vendors and/or Contractors. -Additional
representative responsibilities will include, but not necessarily
be limited to, the following: -Work collaboratively to identify and
solve pain points
Work with Development Operations and
Cross-Functional Stakeholders to improve business outcomes by
identifying pain points or inefficiencies and leading solution
generation and implementation:
Define key business questions,
analyze data and trends, identify improvement opportunities, and
develop process improvement plans. Lead development and
presentation of business cases, summarizing the situation,
opportunity, cost, expected value returned and anticipated
challenges or risks.Work with Clinical Trial Ops, Clinical Business
Ops and Study Teams to optimize clinical programs:
Refine and/or streamline operational
strategies, vendor partnerships, and systems.Identify lessons
learned and best practices through evaluation of processes and
methodologies. Increase reliable delivery against commitments
(e.g., clinical trial milestone targets and budgets).Stimulate key
business processes (e.g., study feasibility, start-up,
enrollment).Use KPIs and metrics to demonstrate improvement over
time and acceleration of clinical programs.
Develop an understanding of
effectiveness and efficiency at the Program- and regional-levels
and integrate into Portfolio- and Department-level views. Identify
opportunities to standardize/harmonize and ensure initiatives align
with our overarching strategy.Propose new ways of working by
applying knowledge of Industry trends and best practices with an
assessment of internal processes and functional capabilities.
Support the development and implementation of new/enhanced
standards, tools, and templates to help Teams be more efficient and
effective.Identify and evaluate new and emerging clinical trial
solutions and technologies aimed at trial optimization.Engage in
external scouting (e.g., conferences, special interest groups,
networking events) to identify new vendors and partner with
Procurement on category analyses to enhance our strengths and fill
gaps.Metrics Champion /Cycle Time Optimization
Function as the SME for clinical
trial operational performance metrics management and continuous
improvement. Analyze and report out on performance metrics relative
to industry benchmarks at the enterprise, Project, Regional and CRO
Partner level using internal and external (e.g., KMR) data
sources.Harness clinical trial performance metrics to drive cycle
time optimization. -Demand Planning and Capacity Management
Own resource management and
demand/capacity planning process for the Dev Ops Leadership Team.
Develop strategies to help the Team grow/scale up (FTE, Contractor,
FSP) to meet pipeline needs. -Leadership
As a LT Member, contribute to setting
annual clinical trial and non-project initiative goals and
prioritization. Serve as a central member on strategic
decision-making teams. Utilize negotiation skills, cultural
sensitivity/awareness, and technical knowledge to win support and
cooperation from other functional areas and influence decision
making. -Miscellaneous Run clinical program/trials, if
needed.Qualifications:
Bachelor's Degree required. Master's
Degree preferred. Minimum of 12 years of relevant and progressive
Dev Ops/Clin Ops experience required, including a minimum of 10
years running clinical trials for a Sponsor company.Leadership
experience requiredKnowledge & Experience:
Proven experience developing and
executing strategies which elevate organizational performance.
Adept at identifying opportunities to enhance productivity and
driving positive business outcomes. Inquisitive Leader who
challenges the status quo and possess a continuous improvement
mindset. Strong foundation and experience running global clinical
trials/programs, preferably in rare diseases, to enable critical
evaluation of processes and identification and implementation of
best practices.Deep knowledge of drug development and the
interconnectivity between Functions. Proven ability to develop
strong cross-functional partnerships and work collaboratively to
solve problems. -Effectively negotiates and influences to
successfully lead Teams and solve high impact problems.
Demonstrates leadership skills necessary to serve as a Leader
within Dev Ops and be viewed as same by Insmed Senior Management,
cross-functional Stakeholders, and external Suppliers. Understands,
identifies, communicates, and mitigates risks at both strategic and
operational levels. Ability to set goals, prioritize and manage
multiple responsibilities simultaneously.Detail- and
quality-oriented with a demonstrated track record of driving
projects/deliverables to completion within established timelines,
budget, and allocated resources.Well-connected in the Industry with
deep knowledge of relevant vendors and
software/technology.Successfully exhibits Insmed's core values:
Collaboration, Accountability, Passion, Respect, and Integrity.
Experience functioning at a high level in a dynamic workplace.
Ability to think strategically and translate ideas into tactical,
actionable plans.Experience in the areas of Change Management and
Project Management. Functions independently and is a
self-starter.Up to 20% travel -Insmed Incorporated is an Equal
Opportunity/Affirmative Action employer. All qualified applicants
will receive consideration for employment without regard to sex,
gender identity, sexual orientation, race, color, religion,
national origin, disability, protected Veteran status, age, or any
other characteristic protected by law. -Unsolicited resumes from
agencies should not be forwarded to Insmed. Insmed will not be
responsible for any fees arising from the use of resumes through
this source. Insmed will only pay a fee to agencies if a formal
agreement between Insmed and the agency has been established. The
Human Resources department is responsible for all recruitment
activities; please contact us directly to be considered for a
formal agreement. -Please note that we review every submission, and
we will keep all submissions on file for six months. -
Keywords: Insmed Incorporated, Trenton , Sr Director, Clinical Program Optimization, Healthcare , Bridgewater, New Jersey
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