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Medical Director, Clinical Development

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

Job Description:

Medical Director/ Sr. Medical Director, Clinical Development Company: Black Diamond Therapeutics, Inc

Location: Cambridge

Posted on: September 12, 2020

Job Description:

661 University Avenue Toronto, ON M5G 0B7 Canada

Medical Director/ Sr. Medical Director, Clinical Development JobLocations US-MA-Cambridge

ID 2020-1036

Category Clinical Development

Type Regular Full-Time

Overview Black Diamond Therapeutics is a precision oncologymedicine company pioneering the discovery and development of smallmolecule, tumor-agnostic therapies. Black Diamond targets undruggedmutations in patients with genetically defined cancers for whomlimited treatment options currently exist. Black Diamond is builtupon a deep understanding of cancer genetics, protein structure andfunction, and medicinal chemistry. The Company’s proprietarytechnology platform, Mutation-Allostery-Pharmacology, or MAP,platform, is designed to allow Black Diamond to analyzepopulation-level genetic sequencing data to identify oncogenicmutations that promote cancer across tumor types, group thesemutations into families and develop a single small molecule therapyin a tumor-agnostic manner that targets a specific family ofmutations.

The Medical Director will be responsible for clinical researchactivities pertaining to Black Diamond's lead clinical asset,BDTX-189 as well as future clinical candidates as they move fromdiscovery into IND-enabling activities. The Medical Director willengage relevant scientific/medical experts and key opinion leadersin order to manage clinical data generation from company-sponsoredtrials and other sources with the goal of obtaining regulatoryapproval for patients with an unmet medical need.

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.

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.

Represent Black Diamond Clinical Development at scientificmeetings, advisory boards and other outreach, as needed.

Qualifications Experience & Qualifications :

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

At least 4-5 year 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.

Must be able to meet deadlines in a fast-paced quickly changingenvironment.

A proactive approach to problem-solving with strongdecision-making skills.

Professional level verbal and written communications skills.

This job operates in a professional office environment withtravel activities of approximately 20-30% of the time.

Physical Demands :

The physical demands described here are representative of thosethat must be met by an employee to successfully perform heessential functions of this job.

While performing the duties of this job, the employee isoccasionally required to stand; walk; sit; used hands to fingers,handle, or feel objects, tools, or controls; reach with hands andarms; climb be stairs; talk or hear. The employee must occasionallylift or move office products and supplies, up to 20 lbs.

Black Diamond Therapeutics is an equal opportunity employer andwelcomes and encourages all applications. Diversity and inclusionare important core values and will encourage our creativity andgrowth as a company. Accommodations are available on request forcandidates taking part in all aspects of the selection process. Wethank all applicants for their interest, however, only thoseselected will be invited for an interview.

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Keywords: Black Diamond Therapeutics, Inc, Cambridge , Medical Director/ Sr. Medical Director, Clinical Development, Other , Cambridge, Massachusetts

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