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Director/Sr. Director, Clinical Operations
Description
Director/Sr. Director, Clinical Operations | (remote-based) | Neuroscience | Report to COO | RETAINED SEARCH
Cornerstone Search Group has been retained by an attractive clinical-stage biotech company focused on developing cutting-edge therapies in the neuroscience area. This is an exciting time within the organization as they are progressing forward in development and you would be joining a company with significant upside potential. This is a hands-on role where you will report into the COO and have the ability to truly impact from day one. Given the smaller company environment, our client is seeking someone who is flexible, embraces startup biotech, and is comfortable working in a very hands-on capacity.
Features
- Impact & Visibility: A high-impact role where you will work alongside of the CEO, COO and other Senior Leadership folks, and play a key role in the continued growth/success of the company.
- Exciting Company: Our client has been highlighted in a number of publications as one of the most promising young biotech companies in the neuroscience space.
- Tremendous Upside Potential: Join a company that is trending in the right direction with significant upside revenue potential in a very hot therapeutic area.
- Small Biotech Culture: The company offers all the attractive features sought with a smaller fast-paced biotech company (autonomy, small team camaraderie, high-impact, agility, minimal layers/bureaucracy) which fosters more collaboration, communication and swifter decision making (i.e. emphasis on progress and moving things forward).
- Accomplished Executive Leadership: You will work closely with an industry-experienced and accomplished Exec. Leadership team with proven successes leading both early/pre-IPO biotechs and late-stage companies through commercialization.
Responsibilities
TRAVEL: As one of the key faces of the company, this is a site-facing role which requires the flexibility to travel (building relationships with sites, investigators, etc).
RESPONSIBILITIES:
- Responsible for the operational leadership and management of the company’s clinical studies. Oversees study operational strategy and tactical planning working collaboratively across various departments.
- Provide operational expertise in the development of the overall strategy and objectives of clinical plans and assume accountability for the timely execution of clinical programs.
- Serve as the clinical operations representative to the development team. Work cooperatively with the team leader, medical lead and project/program team members to provide clinical development expertise (directly and/or from internal and external clinical experts, as needed) in order to create the clinical development strategy for the GDP. Identify and communicate threats to the strategy, project timelines, and milestones, and propose alternative opportunities and/or resolutions.
- Management and oversight of CRO vendor partners, driving quality performance to achievements and deliverables.
- Provide operational input into lifecycle development plans including scenario planning, high-level forecasting of timelines, assessment of program-level feasibility, estimation of resources and budget.
- Contribute to the development of strategic direction for the following aspects of assigned studies: operational feasibility, financial and recruitment modeling, implementation planning, protocol development, patient recruitment strategies, financial forecasting, and overall operational strategy.
- Coordinate multi-dept activities to ensure successful implementation of the various stages of the clinical portion of the GDP. Provide team with accurate time, budget, forecast and resource (FTE) estimates for activities within clinical research.
- Review CSR findings and discuss, propose, and communicate any revisions/additions to the clinical program to ensure that the strategic objectives are met and are aligned with the development plan.
- Evaluate, refine and make recommendations for various operational constructs for study execution.
- Collaborate effectively with internal and external partners and for ensuring alignment of operational program strategies, goals and deliverables.
DESIRED BACKGROUND & EXPERIENCE:
- An advanced degree in life sciences or related field is preferred.
- 8-10+ years of relevant and progressive clinical operations experience gained working at a pharmaceutical and/or biotech company. Small company experience is strongly preferred.
- Must have the flexibility to travel (to the sites), as this is part of this role.
- Proven ability to work effectively in a fast-paced entrepreneurial environment, to be self-motivated, and to communicate effectively with senior management.
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