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Drug Development Leader

Laboratory Corporation of America Holdings (Covance)

Greenfield, Indiana, United States

<h2≥Job Overview:</h2≥<p style="margin: 0px;"≥Looking to take your career to the next level? We are growing! We have a great opportunity for a <strong≥Drug Development Leader</strong≥ to join the team in our Early Phase Development Solutions group. </p≥<p style="margin: 0px;"≥ </p≥<p style="margin: 0px;"≥<span style="color: black;"≥The Drug Development Leader (Director Level) is an expert in nonclinical drug development with experience taking multiple small molecule drugs and biologics thru the various stages of drug development, from candidate selection through IND enabling and post-IND nonclinical testing required to support clinical development and global regulatory submission (NDA/BLA/MAA). These individuals will have typically functioned as Nonclinical Consultants, FDA reviewers or industry Program/Core Team members representing Pharmacology, ADME and/or Toxicology functions. They are well versed in the regulatory requirements for nonclinical testing to be included in Modules 2 and 4 of the Common Technical Document for IND/CTAs and NDA/BLA/MAAs and how they differ depending on therapeutic area and modality under development. </span≥</p≥<p style="margin: 0px;"≥<span style="color: black;"≥ </span≥</p≥<p style="margin: 0px;"≥<span style="color: black;"≥Ideal candidates must have the ability to understand the scientific rationale for the development of a wide variety of modalities; including small molecules drugs, drug/device combinations, antisense oligonucleotides, peptides, proteins, mAbs, vaccines, cell and gene therapies. A strong understanding of the interplay between nonclinical and clinical development plans and study conduct is also required.</span≥ Experience with regulatory authority negotiations from more than one region and knowledge of immunology and chemistry manufacturing and controls (CMC) is desirable<span style="color: black;"≥. </span≥</p≥<p style="margin: 0px;"≥<span style="color: black;"≥ </span≥</p≥<p style="margin: 0px;"≥<span style="color: black;"≥The Drug Development Leader will utilize their experience to provide nonclinical and translational scientific and strategic advisory service to prospective clients in association with designing scientifically robust, yet time and resource conscious nonclinical drug development programs. These individuals act as the nonclinical scientific lead for conduct of awarded programs and work collaboratively with internal certified program managers, subject matter experts and Study Directors to guide program conduct, prevent avoidable complications and resolve scientific challenges. Where programs also include Covance clinical study operations, the DDL will work collaboratively with the Clinical Development team.  </span≥</p≥<p style="margin: 0px;"≥<span style="color: black;"≥ </span≥</p≥<p style="margin: 0px;"≥This position is in Greenfield, IN or can be <strong≥US</strong≥ <strong≥REMOTE</strong≥ based.</p≥<p style="margin: 0px;"≥ </p≥<p style="margin: 0px;"≥Covance's work in developing new therapeutics has an incredible impact on the lives of millions worldwide. Be a part of this life-saving work.</p≥<p style="margin: 0px;"≥ </p≥<p style="margin: 0px;"≥ </p≥<h2≥Education/Qualifications:</h2≥<p style="margin: 0px;"≥<strong≥Education/Qualifications:</strong≥</p≥<ul≥<li≥PhD in Pharmacology, Toxicology or an appropriate related scientific discipline</li≥<li≥Background and training in pharmaceutics, biochemistry, immunology, primary pharmacology, safety pharmacology, ADME and toxicology are required.</li≥<li≥An up to date awareness of ICH and regional Regulatory Guidelines as well as industry trends is essential.</li≥</ul≥<h2≥Experience:</h2≥<p style="margin: 0px;"≥<strong≥Experience:</strong≥</p≥<ul≥<li≥12-15 years scientific expertise demonstrated in the pharmaceutical industry, specifically related to the drug development process, with an emphasis on small molecule and biopharmaceutical development.</li≥<li≥5+ years representing a functional area, such as Pharmacology, ADME, Toxicology, or CMC on pharmaceutical development teams</li≥<li≥DABT Certification desired, but not required</li≥</ul≥

Job posted: 2021-02-18

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