Are you a scientist knowledgeable about therapeutic R&D for rare diseases, especially neurological diseases such as ALS? Do you thrive on bringing together multiple perspectives, defining key questions and leading meaningful change?
We are helping an organization known for their effusiveness in working with the FDA and public-private partnerships (PPP) to improve regulatory guidelines, outcome measures, etc. for different disease areas. A new effort toward enhancing FDA approvals for ALS and other rare neurological diseases is being organized with drug discovery and development stakeholders from industry, patient groups, research institutes, and clinics. This is a key role to identify stakeholders, establish governance and steering structure, and collaboratively develop strategy to bring measurable improvements, including patient input, into the clinical development and regulatory approval process. To be considered for this pivotal position, you should have a strong scientific background with knowledge of the drug development process for neuro- or rare diseases, a passion for building influential teams, and experience providing leadership in matrixed teams.
The Head of this rare neurological disease consortium will be responsible for the overall strategic planning, management, and activities of the collaborative research endeavors. S/he will coordinate projects, provide operational direction, scientific leadership, and oversight of finance and project implementation. S/he will communicate the vision to key stakeholders (biotech/pharma, academia, nonprofits, government, and regulatory participants, etc), potential contributors, strategic partners, and the scientific community. S/he will manage staff including scientific directors, project managers, and project coordinators supporting the program.
- Provide overall leadership, and administrative and scientific oversight of the PPP’s activities and objectives.
- Lead scientific evaluation of relevant aspects (clinical, pre-clinical, scientific, data, etc.) relating to the work of the PPP.
- In partnership with leadership for matrixed resources and other teams, align the strategic and tactical resource allocation, to ensure the successful and timely completion of committed deliverables.
- Foster relationships with key individuals among regulatory agencies, stakeholders from industry, academia, and patient advocacy organizations, and other research initiatives or collaborative efforts in the field.
- Oversee the development of strategic plans for financial development, pursue fundraising efforts, and build pipeline of funding to achieve key milestones and goals.
- Guide the execution of a detailed work plan and its milestones to develop, evaluate, and prepare applications for submission to the FDA/EMA for the review and potential endorsement of actionable solutions, through the appropriate regulatory mechanisms.
- Ensure program multiyear budget is funded and has adequate cash flow.
- Lead business development opportunities by recruiting new organizations from pharmaceutical, biotechnology, and device industries for membership.
- Collaborate/engage with organizations and other public-private partnerships working in neurodegeneration, including rare, research and drug development.
- Collaborate with other programs and consortia for innovative solutions that may be leveraged for and applied to this specific project.
- Work with administration and management to provide financial oversight of any grants or funds utilized to execute the work of the Initiative.
- Direct project manager(s) for the working groups to design and implement project management, deliverables, and tracking of all collaborative efforts.
- Communicate progress via regular leadership and working group calls with all internal and external stakeholders, active participation in global conferences, workshops and meetings, and scientific publications.
- Provide input to strategic development planning and actively contribute to leadership activities in the company.
- Manage vendors, CROs and consultant relationships.
Required Education and Experience
- Advanced degree in a relevant/ related scientific discipline is required.
- Seven to ten years’ experience in drug development (drug discovery, mechanistic pharmacology, safety assessment, clinical development, or regulatory affairs in the pharmaceutical/biotechnology industry and/or FDA/EMA).
- Five years’ experience leading and managing complex and cross-functional team and deliverables.
- Five years’ experience in external relationships/alliances/stakeholder engagement and CRO/vendor management.
- Proven experience with the design, conduct, and reporting of experiments or studies relevant to applications of novel efficacy or safety biomarkers.
- Regulatory experience is a plus
To apply for this position, confidentially email us here.