Job DescriptionJob #: 1007181
Clinical Pharmacologist 1007181
Job Scope & Purpose:
Our client, a small, emerging Boston-based company, is seeking a dynamic and experienced CLINICAL PHARMACOLOGIST/TOXICOLIGIST to join a team of highly motivated scientists who are translating fundamental insights into novel therapies in all phases of development. Reporting directly to the Vice President of Translational Medicine, this is a unique opportunity to take on a leadership role with a broad range of responsibilities.
The Associate Director/Director will assume primary responsibility for leadership in providing clinical and non-clinical pharmacology and toxicology and ADME/DMPK expertise to the discovery and development teams. The successful candidate will have broad subject expertise including pharmacology, pharmacokinetics, and toxicology with extensive experience in design, execution, and interpretation of in vitro and in vivo studies and applying this knowledge to the advancement and selection of drug candidates.
Primary Job Responsibilities:
- Leadership: Provide expert scientific leadership in the areas of non-clinical and clinical pharmacology, DMPK and toxicology to preclinical discovery project teams, and ensure preclinical packages support clinical development
- CRO selection & oversight: principle accountability for delivering critical project data through a network of external study providers. In collaboration with project teams, select CROs and participate in study design, troubleshooting, data analysis and interpretation, QC/audit and oversight of study reports
- Pharmacology/DMPK: in partnership with the project team, apply an understanding of PK/PD and ADME to support compound advancement and evaluation
- Utilize animal models, define efficacy, pharmacodynamics and translational principles for selection of development candidate molecules
- Design, conduct and analyze DMPK studies to elucidate metabolic fate, drug-drug, and transporter interactions
- Apply state-of-the-art allometric scaling and dose prediction models for oral and parenteral drugs.
- Assist the project team in developing clinical PK and PK/PD/pharmacology plan
- Toxicology: design, operationalize and interpret studies to evaluate candidate molecule toxicities, therapeutic index, and overall risk/benefit assessment
- Translational and Biomarker studies: Facilitate project transitions to Clinical Development in close collaboration with discovery, translational and clinical scientists
- Regulatory: Manage the preparation and/or presentation of nonclinical pharmacology sections of external documents (e.g. Investigator’s Brochure, IND/CTA, PIP, CTD, etc.)
- Flexibility: Must be able to contribute to a portfolio of projects spanning early and late preclinical discovery, translational medicine, and clinical development
- Vision: In collaboration with senior management provide a vision and plan for the future growth of pharmacology/DMPK/toxicology functions
- Communication: Play a key role in representing data, interpretations and nonclinical plans for molecules in our pipeline to external parties
Primary Job Requirements:
- Must have 10+ years of experience in the pharma/ biotechnology industry
- Ph.D. in Pharmacology, Pathology or other disciplines with appropriate experience / PharmD in Pharmacology or Pharmaceutical Sciences / DVM with appropriate experience
- Strong, demonstrable track record of scientific leadership excellence
- Demonstrated small molecule drug discovery experience: a track record of advancing multiple novel therapeutic agents from discovery into preclinical and subsequent clinical development as a project team leader or member
- Experience in successfully selecting and managing CROs to provide high quality, timely and on-budget studies
- Strong written and verbal communication skills - ability to clearly and persuasively articulate complex concepts and strategies to a diverse audience
- Desire and ability to work in a fast-paced, cross-functional, flexible and team-oriented environment
- Ability to influence others to effectively perform their jobs and to be responsible for making sound decisions
- Excellent oral and written communication skills for effectively interfacing with vendors and internal stakeholders
- Possesses a sense of urgency and an ability to anticipate and respond quickly to emerging information
- Act with integrity and respect always
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Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.