Sr. Manager, Clinical Operations (remote-based) | Cutting-Edge & Growing Biotech: RETAINED SEARCH
Cornerstone Search Group has been retained and is working exclusively with an exciting and growing biotech company that is focused on developing a new generation of targeted cancer therapies through its truly cutting-edge science. This is an exciting time at the company as they are advancing forward in development and starting to grow their Clinical Operations team. This is a newly-created position reporting to the Head of Clinical Operations and working directly with the CMO, where you will have the opportunity to truly impact the organization and help shape things here. Given the smaller biotech environment, the right person for this will be an experienced clinical operations professional who is hands-on, flexible, has a long-term mindset, and can effectively collaborate cross-functionally across the organization.
LOCATION: This is a remote-based position located anywhere in the U.S.
ATTRACTIVE FEATURES ABOUT THIS COMPANY & OPPORTUNITY:
- Unique “Ground Floor” Opportunity: This is a great opportunity to get your foot in the door as our client is expanding and starting to grow its Clinical Operations team, which will afford you tremendous exposure and give you a chance to make an impact on the company’s continued growth/success.
- Enjoy the Best of Both Worlds: Join a company that is in a very good place financially and stability-wise with strong partnerships in place, while also getting all the pluses of working in a small biotech culture (high impact, autonomy, creativity, internal growth opportunity, collaboration/camaraderie).
- Great Time to Join: This is a perfect time to join this company while they are still small and at an exciting inflection point as they are advancing several assets further along in development.
- Strong Pipeline/Cutting-Edge Science: Our client is focused on developing truly innovative therapies in the cancer area. They have multiple assets in development, which are partnered with other biotech companies and big pharma.
RESPONSIBILITIES IN A NUTSHELL:
- In summary, given our client is smaller and growing, you will play an active role across the entire Clinical Operations organization. You will need to be hands-on and tactical, while also having the opportunity to develop strategy and planning alongside the Head of Clinical Operations and the CMO.
- Responsible for the oversight of assigned clinical trials and associated activities ensuring that they are executed, conducted, and completed in accordance with corporate goals and objectives, applicable regulations, and SOPs.
- Serve as key contact for functional area representatives in managing operational aspects of protocol execution and daily oncology clinical trial activities/planning/execution of oncology clinical studies.
- Ensure all trial deliverables are met according to timelines, budget, operational procedures and quality standards.
- Evaluate and oversee the activities required to execute, conduct, and complete clinical trials while managing to the established timelines and corporate budgets.
- Function as primary liaison for vendor personnel, site personnel, and internal personnel regarding trial-related topics.
- Oversee trial monitoring activities for assigned trials and personally conduct site visits as needed.
- Ensure regulatory inspection readiness at clinical sites.
- Bachelor’s degree in life sciences or related field. An advanced degree is a plus.
- 5-10 years of relevant clinical operations experience (CRO/vendor management, study/program management, budgets/timelines) gained working at a pharmaceutical and/or biotech company.
- CRO management experience is required.
- Previous experience with oncology trials is preferred.
- Must have a Biotech mindset: flexible, hands-on/get things done attitude, and ability to think outside the box and interact across the entire organization.
Brian Skurka | Partner
P: 973-656-0220 x738
Cornerstone Search Group, LLC
350 Main Street | Chatham, New Jersey 07928 USA
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