Reports to: Sr. Director, Translational Medicine
Location: Greater Boston Area
Email: resume@bpsearches.com
Position Summary
This is an opportunity to provide clinical leadership in developing RNAi therapeutics in our rapidly expanding portfolio, which spans the areas of rare genetic diseases, cardio-metabolic diseases and hepatic infectious diseases. The successful candidate’s primary role will be as clinical lead of the fast-paced [***] program. We are developing [***] as a subcutaneously delivered RNAi therapeutic for the treatment of a rare and devastating renal disease which particularly affects children. The position will entail influencing the overall clinical development strategy for the molecule, designing and driving progress and operational excellence of associated clinical trials. [***] is designed to silence glycolate oxidase in the liver, thereby redirecting the substrate for pathological oxalate generation. A Phase 1/2 proof-of-concept study is being drafted, which in addition to exploring safety is designed to demonstrate a significant impact on disease pathogenesis. Clinical trials are expected to begin in early 2016.
In addition, this role will include interaction with our research group, helping to advise the team on the clinical development feasibility of novel targets and the design of proof-of-concept studies. This work as well as the clinical leadership of the [***] program will involve extensive consultation and collaboration with external experts. It is expected that additional opportunities will arise to lead benchto-bedside early phase clinical development programs.
The Medical Director lead will work in a matrix organization across Preclinical, Regulatory & QA teams to ensure fully harmonized and integrated development strategies. He/she will be a key Development spokesperson at external meetings, including regulatory interactions and scientific meetings.
STRATEGIC & OPERATIONAL
- Be the strategic leader providing a strong, clear voice for the [***] program.
- Develop creative but realistic approaches to drug development and lead clinical efforts to secure global regulatory approvals.
- Provide strategic consultation and guidance to Research on all decisions that have significant clinical components and implications.
- Collaborate closely with Preclinical, Regulatory Affairs and Medical Affairs to ensure tight strategic integration of product development plans.
- Be accountable via Clinical Research and Operations for all relevant timelines and deliverables.
- Supervise closely all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials.
- Be responsible for final review and sign off with respect to all controlled documents including protocols, IBs, informed consent forms.
- Influence internal and external audiences in a high impact, highly visible fashion.
CAPABILITY-BUILDING
- Ability to build and lead a development team to support future growth in any of Strategic Therapeutic Areas, depending on expertise, experience and interest.
A highly driven, dynamic, engaged and accomplished physician-scientist with experience and insight will thrive in this role. Specific qualifications include:
- MD with strong research background or MD PhD, with Board Certification or specialist training in Medical Genetics, Nephrology, Internal medicine or a related specialty; drug development experience in rare diseases would be a great advantage, but not essential.
- 5+ years industry experience or equivalent clinical academic experience
- Regulatory experience preferable.
- Outstanding leadership and collaboration skills working within a matrix environment.
- Comfortable working with Senior Executive Team and on occasion with Board members, and other external audiences such KOLs, regulatory bodies, and investors.
- Experience and knowledge of working with biotech/pharma partner(s).
- Excellent writing and presentation skills.
- Thrives in highly entrepreneurial biotech environment, with some prior experience in a small/medium size company an advantage.
- Embraces our culture of science, passion and urgency.