Head of Program Management

Direct message the job poster from Juniper Biosciences

Juniper Biosciences is a radiopharmaceutical company focused on the discovery, development, and commercialization of novel diagnostic and therapeutic agents. Leveraging cutting‑edge radiochemistry and molecular imaging technologies, we are redefining precision medicine in oncology and other serious diseases. Join a passionate team at the forefront of nuclear medicine and targeted radiopharmaceutical innovation.

The Head Program Manager will lead cross‑functional pharmaceutical development programs from early formulation through commercial launch, with a strong focus on regulatory submissions and external manufacturing. The ideal candidate has hands‑on experience in formulation development, has contributed to the preparation and submission of NDAs and/or ANDAs, and has successfully managed global CMO/CDMO partners. This role sits at the intersection of R&D, CMC, regulatory, quality, supply chain, and external partners, ensuring projects are delivered on time, within scope, and in alignment with company strategy.

• Lead end‑to‑end planning and execution of drug development programs (formulation, process scale‑up, tech transfer, validation, and commercial readiness).
• Develop and maintain integrated project plans, timelines, and budgets; proactively identify risks, issues, and mitigation strategies.
• Facilitate cross‑functional decision‑making and ensure alignment between internal stakeholders and external partners.
• Track and report program status, risks, and milestones to senior leadership through dashboards and regular governance meetings.

• Coordinate and contribute to the CMC sections of NDAs, ANDAs, and other regulatory submissions (e.g., IND amendments, supplements).
• Drive data collection, gap assessments, and documentation from internal teams and CMOs/CDMOs to support high‑quality submissions.
• Partner with Regulatory Affairs to respond to FDA’s queries and ensure timely resolution of CMC‑related issues.

• Serve as primary program interface with global CMOs/CDMOs for drug product and/or drug substance manufacturing.
• Lead tech transfer activities, ensuring clear scope, timelines, and success criteria are defined and met.
• Oversee external project plans, change controls, deviations, and performance metrics; escalse and resolve issues impacting supply or quality.
• Support vendor selection, due diligence, and ongoing relationship management in collaboration with Technical Operations, Quality, and Procurement.
• Collaborate closely with formulation scientists and process development teams to translate lab processes into scalable, robust manufacturing processes.
• Ensure formulation and process development activities are aligned with target product profile (TPP), regulatory expectations, and commercial needs.
• Coordinate development and validation of analytical methods and stability studies in support of product development and filing strategies.

• Implement and continuously improve program management best practices, tools, and templates.
• Ensure compliance with GMP, ICH, and relevant global regulatory requirements in all program activities.
• Travelling to CDMO:
  Up to 30% of the time, this position will spend time with CDMO and testing labs.

• Bachelor’s degree in pharmacy, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field required.
• Advanced degree (M.S. or Ph.D.) in a relevant discipline preferred.

• 7+ years of experience in the pharmaceutical/biopharmaceutical industry/FDA, with at least 3–5 years in program or project management roles.
• Proven track record of contributing to or leading NDA and/or ANDA submissions (CMC sections strongly preferred).
• Direct experience working with global CMOs/CDMOs for drug product and/or drug substance, including tech transfer and commercial or late‑stage manufacturing.
• Hands‑on or closely integrated experience in formulation development (solid oral, sterile, semi‑solid, or other dosage forms).
• Demonstrated success…