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Director of Clinical Oncology - Biotech - Waltham, MA

Company: Michael Page
Location: Waltham
Posted on: July 15, 2021

Job Description:

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

*Description*

* Lead strategic planning for the clinical development programs

* Develop clinical synopsis, protocols and amendments, investigator brochures, and clinical study reports

* Lead clinical study teams and provide appropriate medical monitoring for clinical studies

* Evaluate pharmacology, safety, and efficacy data from ongoing and completed studies

* Conduct literature reviews and prepare summaries to support clinical development programs

* Be medical resource for design and interpretation of clinical and preclinical programs to support development pipelines

* Evaluate potential business development opportunities and conduct due diligence for assessing scientific, medical and development feasibility

* Interact with key opinion leaders related to assigned compounds and therapeutic area

* Being responsible for the relevant section of pre-IND, IND, and other regulatory submissions

* Carrying the primary responsibility in interaction of KOL, PI, consultants for strategic decision making

* Ensure the patient safety in clinical trials

* At least 10 years of Oncology Clinical Development experience

* Clinical practice experience: Board certification in oncology preferred

* Strong leadership skills, and ability to lead clinical team and work effectively with cross functional teams and leaders

* Superior communication, interpersonal and negotiating skills to interact with internal leadership team, external partners and investigators/medical professionals

* Global perspective and mindset, ability to work effectively with colleagues from myriad cultures, backgrounds and geographies

* Ability to proactively look into issues and solve problems

* Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams

* Knowledge in FDA, EMA, JMPD and other regulatory requirements, GCP/ICH

Our client is a startup immuno-oncology immunotherapy company located in Waltham MA.

* Competitive base salary

* Exciting opportunity to join innovative start up focused on immuno-oncology

* Build Clinical Development department from the ground up

Keywords: Michael Page, Waltham , Director of Clinical Oncology - Biotech - Waltham, MA, Other , Waltham, Massachusetts

Click here to apply!

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