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Executive Director
2 months ago
A growing biotech is pioneering RNA-targeted medicines to revolutionize drug discovery and transform lives for patients with unmet needs is looking for an Executive Director Clinical Development - Neurology. The company operates on a hybrid basis out of Boston, MA and San Diego, CA.
The company has a string income from marketed products and they have a rich pipeline in rare disease and particularly neurology rare disease. The Executive Director Clinical Development Neurology will lead clinical teams in the design and implementation of Development Plans.
Major areas of responsibility include integrated development planning, clinical trial design and execution, clinical data analysis, internal and external communication, and contributions to regulatory submissions, publications, and presentations.
RESPONSIBILITIES:
- This role will assume management responsibility of teams implementing Phase 3 programs in a genetic form of ALS and in a rare pediatric neurodevelopment disorder. There is additional key responsibility for helping to build and lead a team to develop a neuromuscular disease asset.
- Interact with external medical/scientific advisors, thought leaders and clinical investigators in the therapeutic area and with internal stakeholders across Research, Development and Commercial to prepare/revise/maintain and efficiently execute Integrated Development Plans. In addition to the vision and strategy, this includes proactively working with others to fill clinical development pathway gaps such as biomarker and natural history study needs
- Medical writing contributions and review of protocols and other critical study documents (e.g., Integrated Development Plan, Investigator Brochures, IND submissions, Clinical Study Reports etc.)
REQUIREMENTS:
- An MD with over 5 years in the industry; strong leadership skills with proven biopharmaceutical industry experience in leading clinical development for early- to late-stage therapeutic programs; and experience in rare neurologic and/or neuromuscular diseases is preferred.
- A strong understanding of clinical trial design, particularly adaptive designs. A thorough understanding of the full range of preclinical and clinical development processes through early to mid-stage drug development would be a particularly good fit for this role.
- Record of accomplishment including developing, planning, designing, and executing clinical studies leading to the successful registration of therapeutics is also highly desirable.
- Experience in regulatory submissions, including interaction with these agencies on novel trial designs and new indications.
- Demonstrated use of a variety of regulatory mechanisms is desired.
For more information on this role please CLICK APPLY and forward your resume. The company is putting renewed emphasis in its neurology division and this role is new and part of this expansion.
You will take a key role in driving an exciting pipeline forward and will be rewarded accordingly with a competitive salary, bonus and excellent long term incentives.
