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Head of Clinical Development

Company: Colorado School of Mines Alumni
Location: Cambridge
Posted on: September 15, 2020

Job Description:

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.

Responsibilities

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 reporting.

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 Drug Administration.

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 management.

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 key initiatives.

Manage and support the success of a growing team that includes Clinical Development and Clinical Study Operation.

Qualifications

Medical Doctor or non-US equivalent of MD degree or Pharm.D, board certified or board eligible in oncology or an oncology-related sub-specialty.

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 operations.

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 communication skills.

Job Information

Job ID: 54113524

Location:

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 approach goes...

View Full Profile

More Jobs from Thrive Earlier Detection Corp. Cloud Engineer Cambridge, Massachusetts, United States 20 days ago Product Lead, Radiology Cambridge, Massachusetts, United States 30+ days ago Senior Scientist, Machine Learning Cambridge, 553096, United States 30+ days ago

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Keywords: Colorado School of Mines Alumni, Cambridge , Head of Clinical Development, Other , Cambridge, Massachusetts

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