Colorado School of Mines Alumni Job Center We are seeking a Head
of Clinical Development who will provide clinical leadership in the
development, execution, and communication of the development plan
for our products. S/he will provide a bold strategic vision and
pragmatic roadmap, while taking a leadership role in fostering a
culture of cross-functional collaboration and respect to integrate
medical, scientific, and commercial input into the clinical
development program, including proactive engagement with key
opinion leaders to inform our development and commercialization
efforts. S/he will have a proven track record in building cohesive
and high-performing, mission-led teams, and be a genuinely
compassionate and inspirational leader.
Builds, leads and supports a team of professionals responsible
for the development and execution of clinical research protocols,
clinical study reports, and scientific publications. Reviews,
interprets, and communicates strategy, progress, and emerging data
of ongoing research projects within and outside the organization.
Forecasts and executes on departmental budget and financial
Ensures that clinical trials are conducted according to good
clinical practice and all applicable regulatory requirements,
standard operating procedures, and other quality standards.
Oversees clinical content to regulatory documents. Contributes
to the development of studies and plans for evidence generation and
clinical content to support regulatory approvals, guideline
inclusion, coverage and reimbursement for Thrive’s current and
future clinical tests. Provides clinical representation for key
engagements with health care authorities including the US Food and
Stays abreast of scientific information and emerging technology.
Attends and participates in company supported events at major
medical meetings and congresses.
Creates the clinical development strategy for current and
planned diagnostics and leads a team that includes medical
directors, clinical development operations, and clinical data
Brings clinical perspectives to corporate strategy in order to
ensure alignment with current and future medical needs for patients
and translates that strategy into specific clinical projects that
support corporate goals.
Partners with internal stakeholders from biostatistics,
technology development, business development, Research and
Development, Engineering, Computational Research, and Product
Management to ensure that Clinical Development activities are
aligned with strategy and to support clinical alignment in
activities developed by other departments. Collaborates with
business development by providing clinical and strategic insight to
Manage and support the success of a growing team that includes
Clinical Development and Clinical Study Operation.
Medical Doctor or non-US equivalent of MD degree or Pharm.D,
board certified or board eligible in oncology or an
Experience in developing and executing clinical trials in the
biopharmaceutical or diagnostics industry, or commensurate academic
experience, including protocol development and design.
Ability to analyze and interpret clinical and efficacy data and
develop written reports and presentations of those data.
Experience selecting and working with CROs.
Demonstrated ability to understand and interpret the regulatory
requirements under which medicines and/or medical devices are
developed, reviewed, and supported.
Direct experience interacting with health care authorities such
as FDA, EMA, PMDA to support clinical trial development and
regulatory approval of medicines and/or IVDs.
Demonstrated experience with good clinical practice and clinical
Demonstrated orientation and credibility with leading oncology
experts, industry peers, and senior level company stakeholders to
support scientific and business strategies.
Experience building and leading cross-functional teams and able
to effectively work in a fast-paced cross-functional environment.
Able to manage and motivate a diverse work group.
Strong leadership experience managing direct reports and
influencing in a matrix environment.
Able to plan and manage departmental budgets, including
long-term planning and actual performance within target.
Excellent interpersonal, verbal and written English
Job ID: 54113524
Cambridge, Massachusetts, United States
Position Title: Head of Clinical Development
A cancer diagnosis is something no one wants to hear. Today, it
is detected late, once it has spread and treatment options are
often limited. But cancer is curable if caught in the earlier
stages. At Thrive Earlier Detection, our goal is to transform this
outlook: to catch cancer earlier, when it can be more effectively
treated. We are developing CancerSEEK, a blood-based test that is
designed to be affordable and utilized as part of routine medical
care to detect multiple types of cancer at earlier stages. Our
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