It continues to be an exciting time for BlueRock Therapeutics as the company advances cutting edge cellular therapies to positively impact patients' lives across multiple disease areas.
BlueRock is recruiting a key member of the Clinical Development group to support and direct preclinical, translational IND-enabling, and clinical development activities of the neurology programs.
In this newly created role, the Senior Medical Director Neurology will be charged with providing scientific and medical leadership and support for BlueRock's neurology programs. Reporting to the Senior Vice President Clinical Development, this role will work closely with program leads and other subject matter experts to expand and execute on the company's development pipeline. The successful candidate will be a clinical and scientific leader and resource, and they will support relationships and activities within BlueRock and externally with BlueRock partners.
The successful candidate will be a clinician scientist with both an interest and experience in preclinical as well as clinical stage development programs. They will build and maintain strong collaborative efforts with both internal and external partners and will provide guidance to research teams and IND-enabling and clinical-stage activities. They will contribute to highly productive, cross-functional development teams (such as research, regulatory, CMC, clinical development, clinical operations, and IP) within a dynamic matrixed environment. The position will be based in Cambridge, Massachusetts, with the potential to be hybrid or remote.
Responsibilities:
- Provide expert scientific and medical support and leadership to both preclinical and clinical stage BlueRock programs
- Support development and progression of a robust BlueRock neurology pipeline
- Establish strong relationships with thought leaders in the field
- Represent the company in the neurology space both internally at meetings and externally, including global conferences.
- Support the neurology pipeline by contributing to the assessment of potential new products or programs
- Work with cross-functional teams, and contribute to strong, collaborative efforts to strengthen internal capabilities
- Lead, contribute to, and provide oversight to development of clinical documents
- Contribute to the analysis, interpretation and reporting of preclinical and clinical data
- Provide clinical and scientific content and detailed review for regulatory documents, and contribute to the overall strategy in regulatory submissions and interactions
- Provide strategic programmatic input through interaction with the development leadership team
- Provide mentorship and support to more junior team members
Minimum Requirements:
- MD or MD/PhD in a relevant discipline is required (neurology strongly preferred)
- Industry experience in neurology clinical development required
- Minimum of 6 years of experience, or a combination of relevant education and experience
- Proven ability to lead teams by example and promote company culture
- Effective communicator with excellent verbal and written communication skills
- Interest and experience in preclinical/early development stage programs
- Experience in design and execution of clinical studies
- Knowledgeable in drug safety, compliance and cGMP
- Ability to analyze, interpret, summarize and clearly communicate scientific data
- Ability to work independently
- Strong judgement and decision-making skills
- Experience with and understanding of regulatory requirements drug development, and excellent regulatory writing skills
- Ability to collaborate cross-functionally and with external stakeholders
- Experience in cell or gene therapy is a strong plus
#LI-AL1
|