Sr. Director, Clinical Research & Operations: Very stable, growing Biopharma – Central NJ: RETAINED SEARCH
SUMMARY: Cornerstone has been retained by a very stable and growing Biopharma that is continuing to expand their Clinical Research & Operations team. They are looking to hire a Senior Director of Clinical Research & Operations to oversee Clinical Operations, Development, Strategy, Design and People Management of the department. Our client offers a “best of both worlds” working environment. They operate in a nimble and creative work environment with an exceptional culture which is exemplified by the incredible tenure of their employees. While operating like a smaller company without the typical larger company obstacles, they are also extremely stable to include a marketed product and a strong appetite for further growth.
POSITION: Senior Director, Clinical Research & Operations
LOCATION: Our client is located in an ideal part of Central NJ that allows for candidates to commute from Northern, Southern and Central NJ as well as Eastern PA.
ATTRACTIVE FEATURES ABOUT THIS POSITION AND COMPANY:
- Company Culture/Environment: People genuinely like to work here and they stay. The tenure of their employees is well above industry average. They offer a culture and environment that is highly collaborative, trusting and forward-thinking.
- Visibility: A challenging, highly-visible role where you will work alongside of C-level Executives. You will work very closely with the CSO who is hands-on and highly respected within Industry.
- Marketed Product: Our client already has a marketed product with an appetite for further growth and development. This is not a typical high-risk Biotech focused solely in Clinical Development without revenue coming in.
- Growth Potential: This company is looking to continue to grow both as a whole and within the Clinical Development & Operations department.
- The Senior Director will have responsibility for directing operations, strategy, design and people management across clinical studies and clinical development programs.
- Ownership and management of internal and external Clinical Development & Operations teams responsible to identify, select, and manage contract and consultant resources as appropriate to successfully accomplish goals.
- Lead people and cross-functional teams with minimal supervision, communicating effectively, thinking strategically and driving collaborative efforts for positive results.
- Support R&D leadership by contributing to medical presentation/publication initiatives in reviewer and editorial roles, and potentially also as an author.
- Assess clinical components of potential business development opportunities, competitive activities, and will support associated initiatives relating to business objectives.
- Leads and directs internal/external multidisciplinary teams on clinical development initiatives, including the design, planning, conduct, analysis, and results reporting of clinical trials.
- Develops and implements strategies and risk-mitigation approaches to ensure clinical trial objectives are met within prescribed time and resourcing parameters.
- Tracks key study metrics and proactively identifies risks to timelines and budgets, and fosters development of tactics and contingency plans to address such issues.
- Develops responses to external inquiries (e.g., regulatory authorities, IRB’s, partnering organizations, etc.).
- Directs preparation of clinical components of regulatory submissions, provides ad hoc support for regulatory inquiries and submissions as needed.
- Supports R&D management with research/input on clinical development issues associated with potential partnerships, acquisitions and/or competitors.
- Fosters commercial efforts with scientific publication support.
- 10+ years clinical research and drug development experience in the pharmaceutical industry, with demonstrated increases in competencies, responsibilities, and accomplishments, including management of regional and global programs across varied therapeutic areas.
- Demonstrated expertise in trial design and execution, CRO selection, study initiation, maintenance, and risk mitigation throughout, leading to study completion with high quality datasets and final reporting and publication of results from successful (Phase I-IV) clinical development programs.
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Thomas Fascia | Partner
P: 973-656-0220 x717
CORNERSTONE SEARCH GROUP – Pharma & Biotech Executive Search
PO Box 5657 | Parsippany, New Jersey 07054 USA