Gene-Based Therapy Product Development Consultant

Title: Gene-Based Therapy Product Development Consultant - Oligonucleotide Chemistry, Manufacturing & Controls (CMC)
Location: Remote
Status: Part Time
Travel: No
Salary Range: $100 - $150 per hour

Position Summary:

The National Institute of Neurological Disorders and Stroke (NINDS) supports the translational development of novel therapeutic products through NIH drug discovery and development programs, including the NIH Blueprint Neurotherapeutics Network (BPN), HEAL Initiative Pain Therapeutics Development Program (HEAL PTDP), and URGenT programs. These programs provide researchers with access to industry-style drug development expertise and services intended to advance promising therapeutic candidates from discovery through preclinical development, Investigational New Drug (IND) submission, and clinical evaluation.

The Gene-Based Therapy Product Development Consultant - Oligonucleotide CMC shall provide senior-level subject matter expertise in chemistry, manufacturing, and controls (CMC) to support the development of gene-based and oligonucleotide therapeutic products. Primary areas of expertise include synthetic oligonucleotides such as antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs), as well as other gene-based therapeutic modalities including adeno-associated virus (AAV), lentiviral vectors, and non-viral vector therapeutics.

The CMC Consultant shall provide this support on an ad hoc basis and while serving on NIH Lead Development Teams (LDTs) and/or Multidisciplinary Project Teams (MPTs). These teams include Principal Investigators (PIs), NIH staff, and subject matter expert consultants and are responsible for mapping out product development and clinical evaluation strategies, establishing milestones, and overseeing manufacturing and nonclinical research activities performed by Contract Manufacturing Organizations (CMOs/CDMOs) and Contract Research Organizations (CROs).

The CMC Consultant is expected to provide support services in a collaborative manner. Assigned projects may range from exploratory and early development through preclinical safety studies, IND-enabling activities, and clinical trial stages. Consultants may be assigned to multiple therapeutic development projects and must be able to manage competing priorities while providing timely, high-quality technical recommendations.

Duties/Responsibilities:

• Demonstrated senior-level oversight of research and development efforts for gene-based or oligonucleotide therapeutics products
• A track-record of successfully building and leading therapeutic development teams
• A significant track record of scientific accomplishment as evidenced by publications and/or contributions to the development of marketed products
• Experience in team leadership, consulting, or service on strategic and advisory boards are desired
• Must be able to work in a virtual, cross-functional team environment and manage competing priorities
• Must participate actively in project team discussions
• Must have strong interpersonal skills, attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy
• Broad experience across the entire biologics discovery and development process is especially desired
• Must have experience working with multi-disciplinary teams at a senior level preferably in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels

Minimum Requirements:

• A MS, PhD, or MD in a relevant scientific discipline is preferred. If a BS or MS, must have PhD-level experience in biopharmaceutical industry.
• Must have at least 10 years of relevant professional experience
• Must have at least 10 years demonstrated experience in oligonucleotide/siRNA therapy product development
• Must have at least 10 years of experience in managing or being a senior leader in t therapeutics development projects in the biopharmaceutical industry
• SME consultants supporting the URGenT program must also have at least 5 years of experience in supporting rare and/or ultra-rare product development programs
• Experience with biologics development for nervous system conditions is preferred but not required
• Experience interacting with the FDA or other regulatory authorities preferred
• Extensive understanding of FDA or other regulatory agency requirements for IND submissions and clinical trial execution (and when applicable for ultra-rare diseases) is preferred

Benefits:

KIC offers a comprehensive benefits package to eligible full-time employees including Medical, Dental, and Vision Insurance, 401k with Match, Life and ADD Coverage, Short- and Long-Term Disability, Paid Time Off and Holidays, Education Assistance/Tuition Reimbursement, Employee Assistance Program, Employee Discount Program, and more!

Apply online at our website: https://kikiktagruk.applicantpool.com/

Disclaimer:

This is not to be an exclusive list of all responsibilities, duties, and skills required of the person in this job. KIC is an Equal Opportunity Employer as to all protected groups, including protected veterans and individuals with disabilities. Pursuant to The Alaska Native Claims Settlement Act 43 U.S.C. Sec. 1601 et seq., and federal contractual requirements, Kikiktagruk Inupiat Corporation may legally grant certain preference in employment opportunities to KIC Shareholders and their Descendants. Successful candidates must adhere to KIC's Drug and Alcohol policy/testing requirements and may be required to pass a background and/or Motor Vehicle Records check. The salary range for this position is based on several factors, including relevant experience, education, skills, and current market conditions.