Job Description

Job Title: Senior Director, Pharmacology & Toxicology

Reports To: Chief Scientific Officer

Function: Pharmacology and Toxicology

Department: Research

Location: On-site in San Diego, California

OBJECTIVES: 

This role provides strategic and operational management of in vivo pharmacology and toxicology studies are conducted in line with appropriate regulatory guidelines and standards, these include FDA, WHO, GLP, & ISO . The candidate will serve as a technical leader for Trotana for Immunology and Oncology drug discovery and development efforts. Accountable for nonclinical toxicology, working in collaboration with nonclinical pharmacology and pharmacokinetic scientists to drive the overall nonclinical regulatory submission strategy and coordination for multiple portfolio products from discovery to preclinical and subsequent clinical development.

ACCOUNTABILITIES:  

· Work with multi-functional teams and serve as primary toxicologist and in vivo pharmacology liaison.

· Key responsibilities include compound formulation, preliminary and GLP safety assessment and assessments of efficacy and PK/PD for drug candidates. Collaborate closely with other scientists from the research team in Trotana.

· Gather information and provide guidance to project teams regarding all testing standards.

· Lead or manage the design, monitoring and interpretation of In Vitro, In Vivo or pre-clinical safety studies conducted under Good Laboratory Practices (GLP).

· Experience in authoring regulatory submissions, including full BLA/NDAs or significant sNDAs, as well as multiple INDs and preparing detailed science-based responses to regulatory questions.

· Experience in designing, developing, and validating relevant in vivo pharmacology related models for Immunology and Oncology therapeutic areas.

· Contributes to the development of new disease models, explores disease mechanisms and mechanisms of drug action in vivo and provides in vivo proof of concept for novel therapeutic targets.

· Assumes team member representation at project teams, including active participation in both departmental and cross-departmental interactions.

· Plans implements and manages internal and external in vivo pre-clinical activities and interactions to deliver key experimental studies to support drug candidates to IND submission.

· Deep understanding of QA, regulatory, and clinical functions to guide key nonclinical activities, setting up drug candidates for success at all stages of development.

· Working knowledge of CMC, and product quality, to enable impurity assessment and justification of specifications

· Diligently performs assigned lab and company responsibilities.

· Maintains concise, accurate, and comprehensible written records as per Trotana’s policy.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

· Ph.D. in toxicology or related discipline with more than 10 years of hands-on experience

· 5+ years’ experience in toxicology evaluation of multiple species with focus on small molecule pharmaceutical research and development

· D.A.B.T. certification or eligibility

· CRO experience in toxicology

· Experience managing study teams

· In vivo pharmacology technical proficiency especially in inflammation and autoimmune disease models.

· A record of accomplishment managing multiple pre-clinical studies concurrently.

· Strong project management skills and experience managing complex timelines for pre-clinical studies

· Experience with clinical and nonclinical programs in biotechnology and pharmaceutical industries

· Strong communications skills and a track record of accomplishment managing client relationships as well as regulatory agencies

TRAVEL REQUIREMENTS:

· Ability to drive to or fly to various meetings, or CRO sites including overnight trips.

FURTHER INFORMATION :

·  Salary range: $190k-$260k

Trotana is a biotechnology company based in San Diego. In addition to a competitive compensation package with stock options, the company offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, life insurance, disability insurance and a 401(k) plan. The company is an Equal Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. 

To be considered as an applicant, please submit your resume/CV referencing the specific position of interest to [email protected]. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. 

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