Executive Director/Vice President Early Clinical Development

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

Job Description:

Executive Director/Vice President Early Clinical Development Company: Nimbus Therapeutics, Inc.

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Executive Director/Vice President Early Clinical Development(MD) The role & responsibilities of the Executive Director/VicePresident Early Clinical Development (MD) Reporting to the ChiefMedical Officer, the Executive Director/Vice President EarlyClinical Development will have overall accountability for thedevelopment and implementation of small molecule clinical programsin the therapeutic areas of immunology/inflammation, oncology, andmetabolic diseases at Nimbus. We are seeking a highly motivated,collaborative, results-oriented individual with the creativity,resourcefulness, and flexibility to excel in a growing company.

The Executive Director/Vice President Early Clinical Developmentwill: Develop programmatic clinical strategy; overseeimplementation of clinical programs in line with the clinicalstrategy and ensure patient safety and data integrity

Drive and/or oversee the design, execution, analysis,interpretation, and reporting of clinical studies, both early andmore advanced, in collaboration with R&D team members, in amatrixed and highly collaborative team environment

Serve as a Medical Monitor for early (clinical pharmacology,including first in human, DDI, proof of mechanism/concept) and/ormore advanced clinical studies; may serve as Project Team Leaderfor clinical stage programs

Assess trade-offs and build alignment with team members toenable informed programmatic decision-making

Support development and implementation of program biomarkerplans and ensure successful implementation at study site(s)

Lead/author clinical portions of regulatory submissions andresponses to regulatory agency questions; as appropriate, serve asa company representative for regulatory interactions

The Qualifications We Are Seeking M.D. or M.D., Ph.D. with 8+years of relevant experience in biopharmaceutical industry,including significant small molecule drug developmentexperience

Educational background in a relevant scientific discipline(e.g., biology, biochemistry, immunology) and advanced degree(s),including as Doctor of Medicine and post-graduate medical orscientific training; specific therapeutic experience in immunology,oncology, and/or immuno-oncology

Prior experience as a functional leader (e.g., early clinicaldevelopment, clinical pharmacology, experimental medicine); projectteam leadership and line management experience expected at the VPlevel

Broad understanding of biopharmaceutical drug development,including working knowledge of relevant ICH and GCP guidelines andregulations

Passion and proficiency in developing and nurturing keypartnerships and collaborations with external parties, includinginvestigators, KOLs, CROs, and the broader scientific community(including academia, governmental, or nonprofit organizations), aswell as internal discovery and preclinical functions

Record of significant and successful contributions to regulatorysubmissions, including INDs/CTAs, and regulatory agencyinteractions

Experience managing collaborations with consultants,pharmaceutical partners, CROs, and other external organizations isdesirable

Aptitude and interest in serving as a subject matter expert andmentor across the organization

Excellent written and oral communication skills; experiencedelivering effective presentations to both technical andnon-technical audiences

A Snapshot of Nimbus Nimbus is a biotechnology company locatedin the thriving biotech hub of Cambridge, Massachusetts. Wetransform drug development by integrating computational drugdiscovery techniques, a cutting-edge computational chemistryplatform and other advanced technologies to design breakthroughmedicines for patients.

We focus on promising targets in metabolic disease, oncology andinflammation. These include both emerging and well-validatedtargets that have proven intractable to others in thepharmaceutical and biotechnology industry.

Nimbus offers a fast-paced, entrepreneurial, team-focused workenvironment. The culture is intellectually stimulating, flexibleand results-oriented. Joining our team of 30+ people offerssignificant opportunities to grow professionally andpersonally.

We also offer a top-notch benefits package (health, dental,life, vacation, and employer 401K contribution ). Being part ofNimbus (a Nimbi, if you’re curious), allows you to become part of asmall close-knit professional team that strives to bring out thebest in each other by working hard and having fun together.

Join Nimbus. We are making a difference and you can too. Nimbus is an equal opportunity employer. We do not discriminate onthe basis of race, color, gender, gender identity, sexualorientation, age, religion, national or ethnic origin, disability,protected veteran status or any other basis protected by applicablelaw. Nimbus does not accept unsolicited resumes from any sourceother than directly from candidates.

Keywords: Nimbus Therapeutics, Inc., Cambridge , Executive Director/Vice President Early Clinical Development, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Executive Director/Vice President Early Clinical Development, Other , Cambridge, Massachusetts