Sr. Manager, Clinical Operations | Report to CMO | Exciting & Growing Biotech | NJ
Summary: Cornerstone Search Group has been retained by an exciting and growing biotech company focused on developing new therapies in an area of high-unmet need. This is an exciting time at the company as they are progressing further along in development with their lead clinical candidate and now continuing to expand their team. This is a brand new role where you will report into the CMO (who is excellent) and you will be able to impact immediately while also gaining tremendous exposure along the way. Given the smaller biotech environment, our client is seeking an experienced clinical trial management professional who is hands-on, flexible, forward-thinking, and can positively collaborate cross-functionally across all levels within the organization. As opposed to being a small fish in a big pond like in “Big Pharma”, you can be a big fish in fast-paced, entrepreneurial, and growing pond where you will visibly impact the company’s continued success going forward.
Attractive Features about this Position and Company:
- Visible & Impactful Position: This is a newly-created role where you will utilize your clinical study management experience to truly impact the organization from day 1 (unlike in larger companies).
- Great Time to Join: This is a perfect time to join this company while they are at the ground-floor and an exciting inflection point as they are advancing further into development.
- Small Company Culture: Get all the benefits/attractive features of working for a small growing company (impact/exposure, agile, swift decision-making, small team camaraderie, career growth opportunities, etc).
- Accomplished Executive Leadership Team: This company recently raised more than $100 million in capital (so it’s very strong financially) – which is a reflection of the market’s support for this “first-in-class” drug and confidence in its leadership/management team.
- Great Hiring Manager: You will report into an excellent CMO - who is very personable, down-to-earth, and well-respected.
- Provide oversight and management of clinical trials from startup to closeout
- Coordinate internal cross functional teams and act as the main point of contact for study communications
- Work with team to select and manage CROs, consultants, and vendors to ensure adherence to domestic and international regulations and standards (GCP and ICH)
- Work with senior management to negotiate contracts and budgets with investigational sites and other vendors
- Oversee study timelines and clinical trial budgets with finance group
- Ensure timely and accurate documentation and communication of study progress and issue escalation as needed
- Develop plans that deliver studies on time, with the most efficient use of budget and resources, and risk and quality assessment.
- Investigator Meeting preparation and participation, and oversee site closure activities, including post-close out
- Primary point of contact for investigator sites when necessary
- Provide input to all clinical protocols, study manuals, study reports and other key operational/regulatory documents
Desired Background & Experience:
- Bachelor’s degree in life sciences or related field.
- 5+ years of relevant clinical trial/study management experience working at a pharmaceutical or biotech company.
- Familiarity with full life-cycle of a clinical trial: from protocol development and feasibility through study close-out and reporting
- Direct experience managing CROs/vendors
- Experience within hepatology and/or oncology is a plus.
Brian Skurka | Partner
E: firstname.lastname@example.org | P: 973-656-0220 x738
CORNERSTONE SEARCH GROUP, LLC – Life Sciences Executive Search
PO Box 5657 | Parsippany, New Jersey 07054 USA
Recently Completed Retained Searches by Cornerstone:
- Chief Medical Officer | Clinical-stage cell therapy biotech | NYC
- Chief Scientific Officer | Mid-size global biotech | NJ
- President/US Commercial Head | Late-stage biotech
- VP, Oncology Drug Development | Early/later-stage oncology biotech | NJ/NYC
- VP, Clinical Operations | Clinical-stage gene therapy biotech | Philadelphia
- VP, Clinical Operations | Oncology start-up biotech | NJ
- ED, Clinical R&D, Oncology | Early-stage I-O biotech | Boston/Cambridge
- ED, Early Development, I-O | Top 10 Onc/I-O Co | Philadelphia area
- Head of Human Resources | Clinical-stage cell therapy biotech
- Senior Director (Head), Global Clinical Operations | Cell/Gene Therapy Biotech | NYC
- Medical Director, Clinical Development Oncology | NYC/NJ area
- Head of Talent Acquisition| Clinical-stage rare disease biotech