Director, Research & Preclinical Development

Location
San Diego, CA
Posted
Jul 18, 2021
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time

 

About the Company:

The Emerald Health Pharmaceuticals Inc. (EHP) vision is to make a significant positive difference in the lives of patients through the development of safe and novel medicines in a wide range of therapeutic indications. Our strategy is the development of synthetic new chemical entities derived from cannabinoid molecules as novel prescription pharmaceutical therapeutic candidates. EHP was founded in 2017 to build a world leading position in the field of cannabinoid science to develop and commercialize our drug candidates.

 

About the Role:

The Director, Research & Preclinical Development, reporting to the Chief Operating Officer, will provide leadership for the strategic nonclinical development of EHP drug candidates. He/she will work collaboratively with internal and external teams, and collaborators/ consultants to plan and execute the overall preclinical development of drug candidates. He/she will support the testing of EHP’s drug candidates in various animal models and design, execute, interpret and report nonclinical studies conducted in various species under non-GLP and GLP conditions. He/she will generate comprehensive reports that assess the pharmacological and toxicological profile of drug candidates, and investigate toxicity relationships. He/she will present studies analyses and interpretations to regulatory agencies in meetings and documents including the IND/CTA, annual reports, investigator brochures, special protocol assessments and market applications. He/she will represent EHP at conferences and present findings internally and externally. He/she will need to be a champion for innovation and lean product development as well as maintain contact with the scientific and pharmaceutical communities to stay current in the field and industry.

 

Responsibilities:

• The Director, Research & Preclinical Development contributes to EHP ongoing and new programs to ensure a smooth transition to development

• Oversees preclinical development programs, ensuring efficiency and success, from pre-IND through approval

• Build preclinical development programs and develop systems

• Develops and executes an overall Pharmacology/Toxicology/Pharmacokinetic strategy for the nonclinical development plans in support of all stages of drug development

• Oversee preclinical development plans to assure that they meet regulatory requirements in major regions and that the studies carried out under the plan lead to successful regulatory submissions, IND submissions, and approvals

• Responsible for the planning, implementation and organization of nonclinical studies along with the use of drug exposure to bridge across species, presentation of data (written and verbal) to EHP team, external collaborators, and the scientific community. The individual will lead or actively participate in representing Preclinical Development on project teams. This individual will also participate in program initiatives that further the business objectives of the company

• Identifies collaborators and CROs to evaluate new chemical entities and formulations. Participate in the design/conduct of preclinical studies in different animal models to evaluate drug product candidates in various indications

• Oversees and leads all Pharm/Tox activities from in vitro to in vivo studies supporting first-in-human (FIH) evaluation and throughout the development process, including study proposals, protocols, reports, interactions and collaborations with internal stakeholders and external vendors and/or collaborators, regulatory documents and post approval efforts

• Ensures that all preclinical development activities are conducted in line with the appropriate quality and regulatory standards and guidelines (e.g., FDA, CHMP, WHO, GLP)

• Ensures that all interdependencies within the Pharm/Tox process (e.g., Bioanalytical, CMC, Quality and Clinical) are aligned and the Pharm/Tox function is fully prepared to support the execution of each study

• Effectively communicates nonclinical findings and their relevance to senior management, project teams, collaborators, and regulatory agencies. Participates in multi-disciplinary drug development teams

• Review and approve study reports, author or review and approve regulatory submissions from Pre-IND submission through NDA, including summary documents. Respond to regulatory requests relating to preclinical studies or data

• Responsible for authoring or reviewing and updating preclinical sections in the Investigator Brochure and updating teams on relevant new safety findings from preclinical studies.

• As part of the R&D management team, ensures optimal integration of the Preclinical Development group with other function within R&D or outside (e.g., Clinical, CMC, Regulatory, Science and Business Development), and provides support as needed

• Manages consultants/collaborators in accordance with organization’s policies and applicable regulations. Provides training and development opportunities internally as needed. Ensures adherence to company policies and quality requirements

• Serves as an in-house consultant. Synthesizes multiple data sources and draws general, non-obvious conclusions

• Defines complex problems, develops approaches and develops experiments with sound judgment

• May independently represent the Company to outside organizations

• Design and implement organizational processes, budget, and identifies needs for additional resources

• Support grant submissions as needed

 

Requirements:

• Ph.D. (or D.V.M.) in Pharmacology, Toxicology or closely related field with a minimum of 10 years of nonclinical experience in the pharmaceutical/ biotechnology industry

• Strong technical competency, organizational and prioritization skills with the ability to drive results on time within budget

• Demonstrated ability to analyze and resolve problems

• Self-motivated, independent and goal-oriented

• Must possess excellent oral and written communication skills

• Ability to present technical information to both technical and non-technical audience is required

• Must be able to demonstrate sound judgement

• Must be able to demonstrate good interpersonal skills

• Ability to build and foster cross-functional collaborations both within and external to the organization

• Demonstrated knowledge of regulatory agency guidance documents and white papers

• Experience compiling R&D and preclinical study protocols, reports, and publications

• Prior experience working in regulated environment with strong understanding of drug development and Good Laboratory Practices