Director, Toxicology, Discovery and Development

As a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition and a passion to create impactful neuromedicines, with fewer side effects, that allow patients and their families to live healthier and more fulfilling lives.

On a molecular scale, our deep understanding of the intricate relationships between receptors, their associated proteins, and their distributions in specific cell types and brain regions enables us to precisely direct medicines to the neural circuits underlying disease pathophysiology.

Nonclinical Safety (NCS), within the Product Development Team at Rapport Therapeutics is seeking a talented and highly motivated Project Toxicologist to provide scientific leadership in the nonclinical safety of candidate medicines. The Product Development Team includes highly collaborative scientists who provide a supportive environment that fosters growth and learning. Nonclinical Safety is responsible for designing and implementing overall nonclinical safety strategy to support the discovery and development, and eventual marketing approval and post-marketing safety for the breadth of the Rapport portfolio.

Responsibilities

In the role as a Project Toxicologist, the ideal candidate is

• Responsible for the oversight of the nonclinical safety-evaluation programs for selected discovery and development drug candidates.
• Responsible for the proper design and timely reporting of exploratory and pivotal toxicity studies, including pharmacokinetic, in vitro toxicity, single- and repeat-dose toxicity, investigative toxicity, safety pharmacology, genetic toxicity, development and reproduction toxicity, carcinogenicity and other toxicity studies.
• Act as a Nonclinical Safety representative on early-, mid and late-stage program development teams.
• Provides scientifically and strategically sound nonclinical development plans to management, discovery and development teams.
• On an as-needed basis, interacts with regulatory agencies worldwide on issues of nonclinical safety evaluation.
• Writes and critically reviews submission documents, such as CTD sections for INDs and NDAs, IBs, DSURs, PIPs, briefing books, etc. to support clinical trials and drug registration globally.
• Participates in discussions with internal development teams and/or regulatory agencies to address safety findings and provide safety assessments.
• Evaluates, proposes, and applies new scientific methodology to enhance scientific excellence and/or productivity in Nonclinical Safety. Works collaboratively across disciplines to identify, characterize, and resolve target/compound-based toxicities.
• Represents Rapport in external scientific and regulatory collaborations, committees and consortia.
• Collaborates with Rapport's Discovery group to help evaluate toxicity of drug candidates.
• Ensures compliance with Good Laboratory Practice, Standard Operating Procedures, and study protocols in conducting nonclinical studies, when applicable. Ensures compliance with all company/departmental policies, particularly those relating to animal welfare and safety.
• Embraces/demonstrates Rapport's Core Values to create an atmosphere of scientific excellence, open communication, and creativity in order to maximize productivity.
• Publish findings in high impact peer-reviewed journals.

Qualifications

• Ph.D in toxicology, pharmacology, pathology or a related field with 8+ years discovery toxicology and/or regulatory toxicology experience is preferred. Candidates with MS degree in toxicology, pharmacology or related field with extensive (12+ years) experience in discovery toxicology and/or regulatory toxicology would also be considered.
• DABT or DABVT with extensive small molecule modality experience is a plus.
• Knowledge of biochemical and mechanistic toxicology, immunology, pharmacology, biology of disease, and/or experimental pathology. Experience designing and interpreting in vitro and in vivo studies exploring mechanisms of toxicology involving biochemical, immunological, functional, molecular, and/or structural endpoints.
• Proven track record of directing or managing or supporting conduct of nonclinical safety studies at CRO or in a biopharmaceutical setting with experience in designing, conducting, monitoring, critically evaluating, and reporting results of safety studies.
• Effective organizational, written and oral communication skills, especially as they pertain to writing clear, and accurate documents and presenting data.
• Individual must be able to manage multiple research and development programs, provide and accept input on data interpretation, foster a spirit of team effort, and be able to work as a team.
• Proven experience of authoring regulatory documents (e.g. IBs, INDs, CTDs).
• Ability to interpret and apply available toxicity data to assess relative risk or hazard to humans.
• Demonstrated strong decision-making and problem-solving skills.
• Dedication to life-long learning and professional development such as by developing or expanding an area of subject matter expertise.

Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

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