Director of Clinical Program Management (Autoimmune)

Director of Clinical Program Management (Autoimmune)

· Home-based within the United States

· Experience expectations vary by level: typically 10–12 years for Director candidates and 6–8 years for Senior Program Manager candidates

· Hands-on experience preparing and managing at least one new U.S. IND required

· Neurology, immunology, allergy or dermatology experience strongly preferred

· Appointment level will be determined based on relevant experience and qualifications

Newave Pharmaceutical Inc. (Newave) is looking to hire a full-time Director of Clinical Program Management (Autoimmune) or Senior Program Manager, depending on experience and qualifications in the United States (remote, work from home). Newave is a biotechnology company headquartered in Pleasanton, California, focused on developing innovative small-molecule therapies in hematological malignancies and autoimmune diseases.

Description

SCHEDULE: Full-time

Work Location

**This is a work-from-home position, and candidates may be located anywhere in the United States. This position reports to the VP, US/EU/UK Clinical Development and leads two U.S. Phase 2 programs in multiple sclerosis (MS) and chronic spontaneous urticaria (CSU), from protocol finalization and FDA pre-IND meetings through IND submission, study start-up and conduct.

Duties

• Lead cross-functional execution of the MS and CSU programs, translating development objectives into integrated plans, milestones and deliverables; report progress, risks and decisions to senior leadership
• Coordinate FDA pre-IND meeting requests and briefing packages; drive IND assembly and submission with Regulatory, Medical, Nonclinical, Biostatistics and CMC; and manage cross-functional responses during the FDA review period and subsequent interactions
• Lead CRO selection and day-to-day oversight, including scope of work, budgets, performance measures, governance meetings, issue escalation and corrective actions
• Select and oversee specialty vendors, including imaging core laboratories, central laboratories, eCOA/ePRO, IRT and clinical drug supply providers; manage dependencies and delivery against agreed commitments
• Lead U.S. academic-site selection, feasibility and start-up; coordinate site budgets, contracts, informed consent forms and regulatory documentation to support timely activation
• Serve as the day-to-day operational partner for lead investigators and key opinion leaders; coordinate investigator meetings and maintain effective site communication
• Oversee enrollment, patient retention, monitoring, data quality and study close-out; identify delivery risks early and drive mitigation with the CRO and internal team
• Manage study budgets, forecasts, accruals and change orders; review CRO/vendor invoices and reconcile actual spending with Finance, explaining material variances
• Contribute to writing, reviewing and coordinating approval of protocols, amendments, informed consent forms, investigator brochures and other study documents with the appropriate functional owners
• Maintain inspection readiness through oversight of trial documentation, eTMF completeness and quality, vendor deliverables and compliance with FDA requirements, ICH-GCP and company SOPs
• Coordinate with the China team, external partners and CROs on study design, data and timelines; resolve cross-functional dependencies and escalate issues requiring leadership decisions
• Contribute to clinical operations processes and, as the function grows, mentor study managers and CRAs; perform other duties necessary to support program delivery

Qualifications

You should have

• Bachelor’s degree or higher in life sciences, nursing, pharmacy, medicine or a related field
• Director level: typically 10–12 years of clinical development experience in biotechnology, pharmaceuticals or a CRO, including at least 6 years leading Phase 2/3 studies or programs
• Senior Program Manager level: typically 6–8 years of relevant experience, including at least 4 years as a study or program lead
• Hands-on experience preparing and managing at least one new U.S. IND, including FDA pre-IND meetings, IND assembly and submission, and management of the FDA review period
• Demonstrated experience leading cross-functional clinical programs, overseeing CROs and vendors, and managing timelines, risks, budgets and contracts
• Experience with U.S. multicenter study start-up and investigator relationships at academic medical centers
• Strong working knowledge of FDA clinical trial requirements, ICH-GCP, clinical trial documentation and inspection readiness
• Strong leadership, communication, organizational and problem-solving skills, with the ability to work independently, manage competing priorities and remain hands-on in a fast-paced biotechnology environment
• Ability to collaborate across U.S. and international time zones and travel as needed for investigator, site, vendor and team meetings

It would be helpful if you had

• Experience in neurology, immunology, allergy or dermatology is strongly preferred; direct experience in MS or CSU is particularly relevant
• Advanced degree in a relevant discipline, such as MS, MPH, PharmD, PhD or MD
• Experience managing imaging-intensive studies, imaging core laboratories or specialty endpoints relevant to autoimmune programs
• Experience collaborating with China-based teams and external development partners
• Experience mentoring clinical operations colleagues and building practical processes or capabilities in a growing biotechnology organization

We would love to talk to you about this opportunity. If you are highly qualified, you will hear from one of our recruiters. We are actively interviewing, so apply today.

We are an equal opportunity employer and value diversity at our company. We do not discriminate based on any legally protected characteristic.

Notice

Our Company's recruiters take the candidate experience very seriously. During recruitment, no recruiter or employee will request financial or personal information by email. Our recruiters will not email you from a public webmail service such as Gmail or Yahoo Mail.

Pay: Up to $240,000.00 per year

Benefits

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off
• Retirement plan
• Vision insurance

Application Question(s)

• Are you currently based in the United States and available to work full-time in a remote position?
• Do you hold a bachelor’s degree or higher in life sciences, nursing, pharmacy, medicine, or a related field?
• How many years of clinical development experience do you have in biotechnology, pharmaceuticals, or a CRO?
• How many years have you served as a study or program lead for Phase 2 or Phase 3 clinical trials?
• Have you had hands-on responsibility for preparing and managing at least one new U.S. IND, including FDA pre-IND meeting preparation, IND assembly and submission, and coordination of responses during the FDA review period?
• Have you directly overseen CROs and clinical trial vendors, including scope of work, performance, issue escalation, and corrective actions?
• Have you managed clinical study budgets, forecasts, accruals, change orders, and CRO/vendor invoice review?
• Have you led U.S. multicenter clinical study start-up, including feasibility, site activation, and investigator relationships at academic medical centers?
• Do you have clinical trial experience in neurology, immunology, allergy, or dermatology?

Work Location: Remote