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Clinical Development Leader

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

Job Description:

Clinical Development Leader - TB Therapeutics Company: Bill & Melinda Gates Foundation

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Clinical Development Leader – TB Therapeutics Cambridge, MA

Reporting to the TB Therapeutics Lead, the Clinical DevelopmentLeader – TB Therapeutics will initially have responsibility for theInstitute’s portfolio of tuberculosis therapeutic programs in earlystage clinical development. Responsibilities will include guidingthe development of individual compounds in preparation forinclusion in the assembly and testing of novel multi-drug regimensfocused on transforming TB treatment. This work will be conductedboth internally as well as in close collaboration with a variety ofnon-profit and industry partners, and the Clinical DevelopmentLeader will contribute to building and maintaining emergingpartnerships that will enable regimen construction with compoundsoriginating from a diverse set of drug developers. Emphasis will beplaced on the development of a standardized set of tools(nonclinical and preclinical models, quantitative science tools,biomarkers) for enabling innovative approaches to TB drug testingand regimen design, ultimately enabling adaptive platformapproaches to novel universal drug regimen development. Whileinitial approaches are expected to focus on anti-mycobacterialcompounds, the portfolio may expand to include host-directedtherapies as well. In all programs, emphasis will be placed onusing cutting-edge translational science to deeply characterize thehost-pathogen interface, enabling the development of novelbiomarkers and therapeutic strategies.

The Clinical Development Leader will be expected to develop thetranslational medicine strategy for a portfolio of 3 to 5 productcandidates from early preclinical development through later stageregimen development. Working closely with an integrated projectmanager and a cross-functional team, the Clinical DevelopmentLeader will author TPPs, clinical development plans and integratedproduct development plans, and oversee protocol authorship andclinical study execution. Study designs may range from highlytranslational experimental medicine studies to large adaptive Phase2b/2c trials Working closely with assay development andquantitative sciences colleagues within the Institute, the ClinicalDevelopment Leader will apply novel technical, bioinformatics andmodeling approaches to the assessment of pharmacokinetics,pharmacodynamics, safety and clinical activity. The ClinicalDevelopment Leader will also build a network of consultingrelationships, collaborations and partnerships with leadingacademics, nonprofits, biotechnology/bioinformatics companies, andregulatory authorities that will place the Institute on the leadingedge of innovation in the tuberculosis drug development space.

QUALIFICATIONS

The successful candidate will be an innovative, resourceful, andhighly creative individual who thrives in a “get it done” type ofenvironment with a strong track record of hands on experience intranslational medicine. (S)he will have the following mix ofprofessional characteristics:

MD, ideally with training in Infectious Disease; training and/orresearch in other relevant areas also considered (e.g.,pharmacology, immunology, etc.)

7+ years of leadership experience in early-phase small moleculedrug development across strategic and operational roles.Antimicrobial drug development experience is a plus.

Translational medicine and clinical pharmacology experience,including a good understanding of preclinical small and largeanimal models, biomarkers, and systems pharmacology, including QSPand model-informed drug development is preferred

Experience working with multinational partners is highlypreferred

Comfortable working across a number of disease areas and able toshift gears quickly. Must be open to change and the unknown with acreative and resourceful nature; a self-starter, proactive andresults-oriented with high performance standards

Strong interpersonal skills with polish and presence; ability toinfluence others at all levels and lead in a highly matrixedorganization

Personal leadership style that inspires trust, confidence, andcollaboration

Passionate, persistent and tenacious. Strong ability toprioritize and operate with a sense of urgency

Extremely bright with a highly strategic nature but alsobalanced with a biotech mindset and a hands-on, roll-up-the-sleevesstyle that gets things done

Trustworthy with highest integrity, committed to ethics andscientific standards

Outstanding communication skills: ability to work well with awide range of internal and external stakeholders and build strongpartnerships and alliances inside and outside the organization

Experience building capability, both internally within ownorganization and externally with a range of partners is desired

Experience in pioneering the start-up of new organizations orfunctions is a significant plus

Demonstrated passion for the Institute’s values with acommitment to deliver results against our mission

#LI-TH1

As part of our standard hiring process for new employees,employment with the Bill & Melinda Gates Medical Research Institutewill be contingent upon successful completion of a backgroundcheck.

The Bill & Melinda Gates Medical Research Institute is dedicatedto the belief that all lives have equal value. We’re committed tocreating a workplace where employees thrive both personally andprofessionally. We also believe our employees should reflect therich diversity of the global populations we aim to serve—in race,gender, age, cultures and beliefs—and we support this diversitythrough all of our employment practices.

All applicants and employees who are drawn to serve the missionof the Bill & Melinda Gates Medical Research Institute will enjoyequality of opportunity and fair treatment without regard to:

* Race

* Color

* Age

* Sex

* Sexual Orientation

* Disability

* Gender Identity

* National Origin

* Genetic Information

* Marital Status

* Prior Protected Activity

Posted 2 Days Ago

Full time

B014821

About Us Our only bottom line is the number of lives saved.Let's change the statistics.

MISSION THE POTENTIAL OF TRANSLATIONAL MEDICINE The Bill &Melinda Gates Medical Research Institute is a non-profit biotechorganization. Our mission is to develop products to fight malaria,tuberculosis, and diarrheal diseases—three major causes ofmortality, poverty, and inequality in developing countries. Theworld has unprecedented scientific tools at its disposal; now isthe time to use them to save the lives of the world's poorestpeople.

Our focus is translational medicine: advancing novel drug andvaccine candidates from the laboratory to human studies. Funnelingmany possible ideas into a few viable solutions is the mostchallenging stage of the research and development process, but weembrace this challenge. We learn continuously from everything wedo. If one or two or 100 ideas don't turn into solutions today,they yield insights that help us succeed tomorrow.

Keywords: Bill & Melinda Gates Foundation, Cambridge , Clinical Development Leader - TB Therapeutics, Other , Cambridge, Massachusetts

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