VP of R&D - Cary, United States - a Pharmaceutical company based in TX

a Pharmaceutical company based in TX Cary, United States

3 weeks ago

Pharmaceutical / Bio-tech

Description

RESPONSIBILITIES

Developing innovative scientific and production strategies to support business expansion and explore new opportunities.
Overseeing the development of chemical synthesis pathways or other methods for producing compounds of interest, aligned with our business strategy.
Providing strategic leadership to develop and implement a comprehensive development strategy for the cannabis and psychedelic portfolio, focusing on achieving key milestones.
Collaborating with management, quality assurance, manufacturing, and other related functions on the development and future deployment of new molecules and formulations.
Working closely with customers and partners to align goals and achieve mutual satisfaction and benefits.
Leading the design and execution of Quality-by-Design (QbD) product development studies and develop scalable manufacturing processes for parenteral drugs.
Managing formulation development for new products, ensuring optimized formulations for performance and stability, studying material compatibility, and evaluating sterilization options.
Enhancing market acceptance of the company's products.
Maintaining effective communication with internal and external stakeholders, including clients, investors, partners, and regulatory bodies.
Presenting development updates, strategic insights, and risk assessments to the executive team and board of directors.
Developing and managing the development budget, ensuring optimal allocation of resources to achieve project milestones and strategic objectives.
Demonstrating strong leadership skills through the supervision, coaching, and mentoring of team members.
Developing scalable manufacturing processes in line with cGMP and regulatory requirements.
Supporting troubleshooting of existing commercial processes as needed.
Providing data and support for the creation, submission, and approval of regulatory documents, including Drug Master Files, INDs, NDAs, and others.

QUALIFICATIONS

Minimum 15+ years of experience and/or knowledge in organic synthesis, process development, and enabling technologies.
Relevant industry experience in pharmaceutical/biotechnology small molecule development and/or business development.
Experience in contract manufacturing (API and Drug Product), drug delivery, and contract research.
Proven track record of successful leadership in API, formulation, and product development, preferably within the cannabis/psychedelic area.
Understanding of the overall drug development process, regulatory guidelines, and CMC strategy in the US, with global experience being a plus.
Ability to effectively interact with and influence suppliers/vendors, regulators, global partners, industry executives, and trade organizations.
Demonstrated managerial experience in leading a team of scientists in R&D, formulation, and quality.
Strong analytical problem-solving skills, with a history of leading and motivating teams to develop innovative and sustainable solutions.
Preferred experience with tradeshows/conferences, established industry connections, and technical writing.
Ability to prioritize and manage multiple complex situations, make strong decisions, and work through ambiguity and uncertainty.
Excellent presentation, communication, and interpersonal skills.

EDUCATION

MD, PhD, or equivalent degree in a life sciences or medical discipline

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