Director, Nonclinical Emerging Therapies

at  ProPharma Group

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The Director, Nonclinical Emerging Therapies is responsible for the conduct of regulatory activities associated with the nonclinical development of therapeutic drug, biologic, and device products. This role will serve as the point person interfacing with clients on nonclinical matters pertaining to the above therapeutic areas, especially those considered to be new/emerging therapeutic modalities from discovery through clinical development and approval.

Essential Functions

• Coordinate and balance priorities of various stakeholders (corporate, scientific, clinical) in the context of regulatory requirements, through active participation in Product Development Teams.
• Provide critical review of relevant documentation supporting regulatory applications.
• Ensure timely preparation of cogent, organized, and scientifically valid submissions to FDA.
• Prepare for and participate in meetings and teleconferences with regulatory agencies; leading nonclinical discussions interactions with the FDA, if requested.
• Develop and implement effective strategies to assist in obtaining regulatory approval of products with optimum cost effectiveness and compliance.
• Provide expertise in translating regulatory requirements into effective plans.
• Support new product development efforts, including interfacing with client development team(s) and/or contract organizations.
• Assist with business development to win new business.

Necessary Skills and Abilities

• Ability to engage with regulatory agencies in addressing scientific and regulatory nonclinical issues, including preparation and submission of successful briefing packages and investigational and marketing applications.
• Solid understanding of multiple routes to clearance or approval of drugs, biologics, and medical device combination products.
• Excellent working knowledge and application of testing and regulatory standards.
• Demonstrated ability to manage multiple and diverse projects concurrently.
• Demonstrated ability to develop positive relationships and collaborations.
• Excellent oral and written communication with cross-functional collaboration skills.
• Strong analytical skills; a strategic thinker, planner and implementer.

Experience Requirements

• 7+ years in positions of leadership in Regulatory Sciences within consulting and/or regulated drug/biologic development organizations.
• Experience leading teams of technical professionals.

Educational Requirements

• Master’s degree in Life Sciences

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
*ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.

• Coordinate and balance priorities of various stakeholders (corporate, scientific, clinical) in the context of regulatory requirements, through active participation in Product Development Teams.
• Provide critical review of relevant documentation supporting regulatory applications.
• Ensure timely preparation of cogent, organized, and scientifically valid submissions to FDA.
• Prepare for and participate in meetings and teleconferences with regulatory agencies; leading nonclinical discussions interactions with the FDA, if requested.
• Develop and implement effective strategies to assist in obtaining regulatory approval of products with optimum cost effectiveness and compliance.
• Provide expertise in translating regulatory requirements into effective plans.
• Support new product development efforts, including interfacing with client development team(s) and/or contract organizations.
• Assist with business development to win new business