Senior Manager, Drug Metabolism & Bioanalysis

Job Description:

Essential Responsibilities:

• Carry out assigned laboratory functions applying knowledge and skill in an accurate, timely manner.
• Establish and maintain excellent working relationships with critical collaborative partners throughout the company.
• Strategize drug metabolism evaluations in supporting Development and Clinical programs
• Provide technical guidance and oversight for CROs during study design and data review
• In vitro and in vivo oligonucleotide metabolism identification
• Drug biodistribution in major organs
• Drug-drug interaction evaluation 
• Plan regulatory bioanalysis to support Development and Clinical programs
• Provides technical guidance to CROs during study design and data review
• Oligonucleotide quantification in biological matrices
• Anti-drug antibody assay measurement
• Ensure deliverables from CROs are met; and prioritize and manage CRO efforts
• Contribute to and review drug metabolism study plans, drug metabolism reports, bioanalytical validation reports, bioanalytical sample analysis reports, toxicology protocols, toxicology sub-reports, clinical protocols, data transfer agreements, clinical lab manuals, and related documents.
• Stay current with industry practice and regulatory guidance.
• Provide budget projections for drug metabolism activities, and contract submission for individual studies
• Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience.
• Maintain all appropriate corporate standards for facility safety and hazardous material management.
• Other duties as assigned.

Essential Physical Characteristics:

On-Site Protocol:

• BS or MS in Analytical, Bioanalytical, Pharmacy, or related scientific discipline
• 12+ years of biotech/pharmaceutical industry or contract research organization
• Hands-on lab experience in drug metabolism or biotransformation is required
• Protein-binding, in vitro and in vivo metabolism identification, drug tissue distribution, CYP inhibition and induction, transporter inhibition and induction, and others
• Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
• Strong problem-solving skills and a proactive attitude towards exploring new approaches.
• Excellent written and verbal communication skills and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role.
• Proficiency working with Microsoft Office Suite Products

Preferred Qualifications:

• Knowledge of oligonucleotide quantitative bioanalysis is preferred
• Knowledge of regulatory bioanalysis is preferred
• Knowledge of ADA and NAb assays is preferred

Required Key Attributes:

• Must be able to work independently as well in cross-functional team settings with supervision as needed.
• Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
• Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment.

Compensation:

• This is a full-time position, Monday-Friday, occasional overtime.
• Pay is commensurate with experience.
• Equity-based compensation
• Performance-based bonuses
• 401(k) with Company Match
• Medical, Dental, Vision
• Flexible Spending Account
• Life Insurance
• Employee Assistance Program
• Employee Discounts 
• Gym Membership
• Paid Vacation
• Paid Holidays
• Paid Sick, Jury Duty, Bereavement

Work Authorization:

• United States (Required)
• Background Check
• As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check.

Company Overview:

ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Disclosure Statement:

• The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
• Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
• The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law.
• Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses.
• Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position. 145000.00 To 165000.00 (USD) Annually