Medical Director/Sr. Medical Director (preclinical, early clinical development) - United States, United Kingdom, Switzerland
- We seek an accomplished Physician to develop transnational and clinical plans for our lead programs in hematology and other therapeutic areas.
- The successful candidate will be responsible for strategic development and tactical implementation of the early clinical studies for our lead programs.
- This will include providing direct medical/physician oversight for phase 1 and proof of concept clinical trials, and clinician input into all aspects of discovery and preclinical development, from target selection to preclinical and regulatory strategy and tactics.
- The ideal candidate will have a thorough understanding of the principles of pharmacology, nonclinical (toxicology) and regulatory requirements for testing new therapies in humans, and experience working closely with clinical operations.
- Understand (and eventually develop into local expert for) the underlying scientific principles of the disease indications and pipeline molecules being studied
- Provide clinical and scientific input into Discovery Research and Early Development activities, including disease education, target identification, lead selection, preclinical pharmacology POC, nonclinical toxicology, biomarker strategy and IND enabling studies, to develop optimal translational medicine approaches to facilitate development to clinical POC
- Contribute to the development of robust product development plans for each program, including providing content for clinical development and other sections, as needed
- Identify and establish relationships with leading KOL’s and principal investigators, including organizing and running KOL meetings, as needed
- Develop (and where appropriate, with clinical operations) protocol synopses and protocols
- Oversee clinical trials as medical monitor
- Regularly review patient eligibility / enrollment and clinical trial data
- Oversee, review and approve clinical study reports, as needed
- Work closely with biometrics and clinical operations to ensure clinical operations and development program success
- Contribute to the development of regulatory strategy and act as the medical expert in meetings with regulatory authorities
- Ensure and support effective leadership, management and governance, and seamless collaboration across all areas of Research and Development
- A medical degree (MD or equivalent) and a minimum of 3 years experience in the pharmaceutical or biotech industry
- Medical monitor experience in preclinical and early clinical development, or clinical translational medicine
- Experience in the development of biologics, in particular Cell and Gene Therapy (or Advanced Therapy Medicinal Product) product development
- Experience with regulatory activities in US and EU, as well as direct experience with IND filing required
- Understanding of the principles of pharmacology as well as nonclinical (toxicology) requirements for testing new therapies in humans
- Fluent English, excellent written and verbal communication skills with successful presentation capabilities
- Ability to travel on average 20% of the time (range 0-30% each month).
- Excellent oral and written communication skills
- Ability to work in a team-oriented environment
- Scientifically rigorous, highly organized, and with significant attention to detail
- Strong scientific research or clinical background in hematology, experience with hemoglobinopathies preferred
- Experience with orphan / rare disease product development
- Prior experience advising on NDA submissions
- Scientific Rigor/Attention to detail – Maintains high scientific rigor and attention to detail in designing and testing hypotheses and analyzing data. Challenges assumptions, demonstrates highly organized thinking and documentation.
- Product Creation - Effective and efficient discovery strategies that will enable us to achieve ~1 IND/year
- Relationship Building – Builds and maintains productive working relationships across a diverse spectrum of people
- Communication and Teamwork – Effectively expresses ideas in written, visual, and oral context. Able to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.
- Passion - Creates an exciting environment where there is a true passion for the vision of the company Therapeutics to bring novel medicines to patients suffering from serious diseases.
- Results Orientation / Productive Work Habits – Drives issues to closure and gets the job done. Skilled at analyzing scope of work, as well as planning and executing a successful outcome. Understands and assigns / utilizes resources effectively and efficiently.