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Medical Director

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

Job Description:

Company: Stratacuity: Proven Scientific Placement

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Senior/Medical Director, Clinical Development - OncologyCambridge, MA

Senior/Medical Director, Clinical Development-Oncology1074008

Job Scope &Purpose:

Our client in early stage development with an excitingoncology-focused platform is seeking a Sr./Medical Directorresponsible for clinical research activities pertaining to thecompany’s lead clinical asset as well as future clinical candidatesas they move from discovery into IND-enabling activities. TheMedical Director will engage relevant scientific/medical expertsand key opinion leaders in order to manage clinical data generationfrom company-sponsored trials and other sources with the goal ofobtaining regulatory approval for patients with an unmet medicalneed.

The ideal candidate will be a medical oncologist or equivalentwith a proven track-record in leading targeted therapy clinicalprotocols in patients with relevant solid tumors. The role willhave the opportunity to contribute on the clinical development ofnovel drug candidates intended to treat patients in a tumoragnostic fashion.

Primary Job Responsibilities:

Collaborate with internal stakeholder in discovery, preclinicaland clinical development and other relevant functions as well asexternal experts, as necessary, to develop and execute clinicaltrials from first-in-human to registration according to corporatetimelines.

Assume medical responsibility of ongoing and planned clinicaltrials. This includes real-time medical monitoring such as patienteligibility assessment, safety and efficacy assessment, addressstudy design and protocol procedure questions.

Perform single-case and aggregate safety review in collaborationwith CRO according to safety monitoring plans.

Assess expectedness of SUSARs to determine expedited regulatoryreporting.

Analyze, interpret and present clinical data. This includescollaboration with investigators on publications of abstracts,posters, and manuscripts.

Participate in writing of clinical study protocols,Investigator's Brochures, clinical study reports, and otherrelevant controlled documents.

Participate in writing of relevant documents and sections forINDs and NDAs as well as responding to questions from regulatoryauthorities and IRBs/ethics committees.

Primary Job Requirements:

MD (or equivalent) with successful academic or medical practiceexperience. Board certification or eligibility in medical oncologyhighly desired.

At least 4-5 years of clinical drug development experienceleading oncology clinical trials within biotechnology orpharmaceutical industry. Similar relevant experience in academiamay be considered.

Strong knowledge of clinical drug development activities inpatients with solid tumors and knowledge of the regulatoryrequirements domestically and ideally internationally.

Strong knowledge of personalized/precision medicine includingutility of relevant biomarker selection strategies, novel studydesign and stratification options. Should have basic knowledge ofcompanion diagnostic requirements.

Personal and professional relationship with relevantinvestigators and key opinion leaders in the medical oncologycommunity.

Strong knowledge about relevant GCP and ICH requirements and FDAregulations.

About Stratacuity:

Whether you are seeking a career change or simply interested inbecoming part of our network, you will appreciate the ethicsguiding each Stratacuity team member. We build lastingrelationships with exceptional biopharmaceutical talent and takegreat care to protect your personal information. Upon receivingyour inquiry, you may be directly contacted by a Stratacuity teammember to discuss your career goals. We will not share yourinformation with anyone without your direct prior consent.

Stratacuity is an Equal Employment Opportunity/AffirmativeAction Employer. All qualified applicants will receiveconsideration for employment without regard to race, color,religion, sex, age, sexual orientation, gender identity, nationalorigin, disability, protected veteran status, or any othercharacteristic protected by law. Stratacuity will considerqualified applicants with criminal histories in a manner consistentwith the requirements of applicable law. If you have visited ourwebsite in search of information on employment opportunities or toapply for a position, and you require an accommodation in using ourwebsite for a search or application, please contact us.

Apex Systems is an equal opportunity employer. We do notdiscriminate or allow discrimination on the basis of race, color,religion, creed, sex (including pregnancy, childbirth,breastfeeding, or related medical conditions), age, sexualorientation, gender identity, national origin, ancestry,citizenship, genetic information, registered domestic partnerstatus, marital status, disability, status as a crime victim,protected veteran status, political affiliation, union membership,or any other characteristic protected by law. Apex will considerqualified applicants with criminal histories in a manner consistentwith the requirements of applicable law. If you have visited ourwebsite in search of information on employment opportunities or toapply for a position, and you require an accommodation in using ourwebsite for a search or application, please contact our EmployeeServices Department at employeeservices@apexsystemsinc.com or844-463-6178.

Apex Systems dba Stratacuity, is an equal opportunity employer.We do not discriminate or allow discrimination on the basis ofrace, color, religion, creed, sex (including pregnancy, childbirth,breastfeeding, or related medical conditions), age, sexualorientation, gender identity, national origin, ancestry,citizenship, genetic information, registered domestic partnerstatus, marital status, disability, status as a crime victim,protected veteran status, political affiliation, union membership,or any other characteristic protected by law. Stratacuity willconsider qualified applicants with criminal histories in a mannerconsistent with the requirements of applicable law.

Keywords: Stratacuity: Proven Scientific Placement, Cambridge , Medical Director, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Medical Director, Other , Cambridge, Massachusetts

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