Position: Non-Clinical Development Scientist

Duration: 1+ year Consulting Opportunity

Location: Remote

Reporting to the Head of Non-Clinical R&D, we are seeking an Assoc. Director of Non-Clinical R&D to support direction and oversight for small molecule discovery and non-clinical development. In collaboration with the head of non-clinical R&D, the successful candidate will interact with project teams and CROs to set scientific and resourcing strategies for preclinical development candidates and IND-enabling studies

Responsibilities

· Key contributor to the company’s strategy of developing first and best in class therapies in Cardiovascular/cardiometabolic disease areas

· Lead the execution and interpretation of key non-clinical studies that support high-priority Corporate initiatives

· Oversee the design, preparation and initiation of study protocols and other required documentation in compliance with project plans, and regulatory requirements

· Support preparation of required non-clinical regulatory filings

· Contribute to growth of the pipeline through diligence of in-licensing opportunities

· Ensure that all Non-Clinical projects are completed, on time, within budget and in accordance with high quality and scientific standards

· Conceive and implement the preclinical strategy for predicting human efficacious and safe starting dose levels for first in human clinical trials

· Represent Non-Clinical as a Subject Matter Expert, develop and maintain relationships with relevant scientific and clinical partners

· Stay up to date with current trends, knowledge, and developments in Non-Clinical development and identify opportunities to update and increase knowledge

Requirements

• PhD in Pharmacokinetics, Drug Metabolism, Pharmacology, or related discipline with a minimum of 5-7 years’ experience in Industry
• Ability to drive non-clinical development of small molecule assets from conception
• Demonstrated ability to predict human efficacious dose and drug-drug interaction potential of small molecules
• Thorough understanding of the external CRO landscape as it pertains to small molecule drug discovery and non-clinical development
• Ability to function in a matrix environment
• Experience with the preparation of documents for regulatory submission (IND)
• Experience in leading the design, conduct, analysis, and reporting of non-clinical studies, including interactions with regulatory agencies
• Development experience with small molecules is required
• Informed with current Biopharmaceutical industry knowledge, news and trends and ability to apply to programs

Skills

· Drug development expertise including non-clinical development planning and execution

· Science driven mindset and ability to find effective solutions to deal with complex matters (e.g. resolving independently or with support of others)

· Excellent influencing, organizational and leadership skills with demonstrated ability to manage, lead and motivate a team particularly across a multicultural organization

· Ability to multi-task, with skill in establishing priorities, managing workload and meeting strict deadlines

· Team worker, who can also work independently, with strong interpersonal skills, ability to communicate effectively and form positive relationships at all levels in and outside the company

· Excellent written and verbal communication skills

· Experience with lipid metabolism and metabolic diseases preferred but not required

Job Type: Full-time

Pay: $90.00 - $110.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Application Question(s):

• How many years of professional experience do you have working in the pharmaceutical industry?
• Do you have experience working closely with CRO companies?
• Do you have cardiovascular or oncology experience within drug discovery?

Education:

• Master's (Preferred)

Experience:

• small molecule discovery: 1 year (Preferred)
• non-clinical development: 4 years (Required)
• IND submission: 1 year (Preferred)

Work Location: Remote

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