Head of Clinical Development

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Company: HCPro, Inc.

Location: Cambridge

Posted on: September 12, 2020

Job Description:

We are seeking a Head of Clinical Development who will provideclinical leadership in the development, execution, andcommunication of the development plan for our products. S/he willprovide a bold strategic vision and pragmatic roadmap, while takinga leadership role in fostering a culture of cross-functionalcollaboration and respect to integrate medical, scientific, andcommercial input into the clinical development program, includingproactive engagement with key opinion leaders to inform ourdevelopment and commercialization efforts. S/he will have a proventrack record in building cohesive and high-performing, mission-ledteams, and be a genuinely compassionate and inspirationalleader.

Responsibilities

Builds, leads and supports a team of professionals responsiblefor the development and execution of clinical research protocols,clinical study reports, and scientific publications. Reviews,interprets, and communicates strategy, progress, and emerging dataof ongoing research projects within and outside the organization.Forecasts and executes on departmental budget and financialreporting.

Ensures that clinical trials are conducted according to goodclinical practice and all applicable regulatory requirements,standard operating procedures, and other quality standards.

Oversees clinical content to regulatory documents. Contributesto the development of studies and plans for evidence generation andclinical content to support regulatory approvals, guidelineinclusion, coverage and reimbursement for Thrive’s current andfuture clinical tests. Provides clinical representation for keyengagements with health care authorities including the US Food andDrug Administration.

Stays abreast of scientific information and emerging technology.Attends and participates in company supported events at majormedical meetings and congresses.

Creates the clinical development strategy for current andplanned diagnostics and leads a team that includes medicaldirectors, clinical development operations, and clinical datamanagement.

Brings clinical perspectives to corporate strategy in order toensure alignment with current and future medical needs for patientsand translates that strategy into specific clinical projects thatsupport corporate goals.

Partners with internal stakeholders from biostatistics,technology development, business development, Research andDevelopment, Engineering, Computational Research, and ProductManagement to ensure that Clinical Development activities arealigned with strategy and to support clinical alignment inactivities developed by other departments. Collaborates withbusiness development by providing clinical and strategic insight tokey initiatives.

Manage and support the success of a growing team that includesClinical 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 anoncology-related sub-specialty.

Experience in developing and executing clinical trials in thebiopharmaceutical or diagnostics industry, or commensurate academicexperience, including protocol development and design.

Ability to analyze and interpret clinical and efficacy data anddevelop written reports and presentations of those data.

Experience selecting and working with CROs.

Demonstrated ability to understand and interpret the regulatoryrequirements under which medicines and/or medical devices aredeveloped, reviewed, and supported.

Direct experience interacting with health care authorities suchas FDA, EMA, PMDA to support clinical trial development andregulatory approval of medicines and/or IVDs.

Demonstrated experience with good clinical practice and clinicaloperations.

Demonstrated orientation and credibility with leading oncologyexperts, industry peers, and senior level company stakeholders tosupport scientific and business strategies.

Experience building and leading cross-functional teams and ableto effectively work in a fast-paced cross-functional environment.Able to manage and motivate a diverse work group.

Strong leadership experience managing direct reports andinfluencing in a matrix environment.

Able to plan and manage departmental budgets, includinglong-term planning and actual performance within target.

Excellent interpersonal, verbal and written Englishcommunication skills.

Job Information

Job ID: 54113524

Location:

Cambridge, 553096, United States

Position Title: Head of Clinical Development

A cancer diagnosis is something no one wants to hear. Today, itis detected late, once it has spread and treatment options areoften limited. But cancer is curable if caught in the earlierstages. At Thrive Earlier Detection, our goal is to transform thisoutlook: to catch cancer earlier, when it can be more effectivelytreated. We are developing CancerSEEK, a blood-based test that isdesigned to be affordable and utilized as part of routine medicalcare to detect multiple types of cancer at earlier stages. Ourapproach goes...

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Keywords: Amazon Workforce Staffing, Cambridge , Head of Clinical Development, Other , Cambridge, Massachusetts