Director / Senior Director CMC Development (Respiratory TA)

Job content

Role and Company Overview

We are currently searching for a Director / Senior Director to lead our Lead CMC development activities for several key early-stage respiratory pipeline projects. You will lead a dynamic, knowledgeable international team. This role will be a mix of strategic leadership and a hands-on tactical role.

Founded in 2011, Covis Pharma is a private equity backed global specialty pharmaceutical company that markets therapeutic solutions in 50+ countries, for patients with life-threatening conditions and chronic illnesses. Our paramount concern is patient’s outcomes as we focus on improving the health of people with serious medical conditions. Apollo Global Management is the private equity sponsor of Covis Pharma.

If you are looking to be a part of a global, vibrant, and fast-growing organization, have a positive attitude, seeking career development and acceleration and are energized by being a part of improving the lives of the patient’s we serve, we are the perfect match for you.

WHAT YOU CAN EXPECT TO DO IN THE ROLE:

Reporting to the Head of QA & Tech Transfer with a dotted line to the Covis Chief Innovation Officer, you are responsible to design and finalize technical target product profiles (with a CMC emphasis) for development-stage projects. You identify appropriate technologies and partners to conduct the development activities for these projects. Technology partners would include both device as well as formulation and drug product manufacturing partners. You manage the activities of development partners to achieve development milestones for the individual projects through proof-of-concept studies in animals and humans. You identify clinical and commercial manufacturing partners and enable technology transfer activities to these partners at the appropriate point in the product development cycle. You work closely with allied functions including project management, regulatory affairs, nonclinical safety, clinical development and commercial functions to align product development efforts. All while working towards and supporting a culture of continuous improvement.

FOR THIS ROLE YOU WILL NEED:

• PhD combined with 10-15 years development experience in the Pharma industry (in addition to any time spent in academic labs)
• Previous experience leading product development efforts in the respiratory space, particularly drug/device combination products. Experience developing other complex dosage forms a plus.
• Previous experience with both early-stage development efforts and overseeing scale up/manufacturing efforts of the dosage forms leading into mid/late-stage clinical trials.
• Specific experience developing above dosage forms with either EMA or US FDA
• Strong technical troubleshooting/problem-solving track-record
• Significant inventorship track record (i.e., with patents filed with the individual as an inventor)

OUR OFFER TO YOU:

By joining Covis Pharma you will be a part of a dynamic and energized team with a vested interest in your personal and professional development. You will be able to provide input into impactful decisions and be a part of shaping our company’s future. The skills and business insight you gain will serve as an invaluable foundation toward developing your career with us. We offer opportunities for advancement and support this through multiple development channels.

Our inclusive company culture brings unique perspectives and embraces diversity of thought. We actively seek to hire and develop the best and brightest team members from all backgrounds ensuring our continued success into the future.

GET TO KNOW US:

Find out more about Covis Pharma by visiting www.covispharma.com

Find out more about Apollo Global Management by visiting www.apollo.com