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VP Clinical Research

Reference Number: 3277
Location: MA

Fairway Consulting Group has been retained to fill the VP Clinical Research position with a rapidly growing pharmaceutical company engaged in the development and commercialization of novel therapies for pain and musculoskeletal conditions.

 

Job Summary:

The Vice President of Clinical Research will be a key member of the Chief Medical Officer’s team with responsibility for supporting the clinical development strategy and operational execution of clinical trials for new products and lifecycle management endeavors.   This person will lead the design and implementation of study plans and have end-responsibility for successful completion of clinical programs within set timelines and budgetary goals. This person will also ensure the collection, analysis, reporting, and publishing of high quality trial data in compliance with GCP/ICH guidelines. The VP Clinical Research will lead the clinical development team, consultants, and other collaborators to ensure studies are conducted per procedures, timelines, and budgets. The VP Clinical Research will play a leadership role in working with other senior managers across the company in defining regulatory strategy, developing programs to support commercial strategy, building the pipeline by working closely with business developments and ensuring that the clinical group as a whole executes clinical programs to highest standards and with optimal cost-efficiencies, including best use of external resources.   

 

Essential duties and responsibilities include but are not limited to the following:

 

·         Responsible for the strategy, planning, and execution of clinical trials to ensure scientific and development plans are consistent with project team and corporate goals.

·         Support and provide input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, and GCP.

·         Design a scientifically rigorous and maximally cost-effective clinical development program for the desired indication(s). Present and defend protocols.

·         Plan and develop solutions to meet future needs; evaluate, benchmark and introduce progressive practices; maintain knowledge of the emerging practices in the pharmaceutical industry; build alliances with external and internal partners to enhance the capability of the function and to ensure alignment on objectives and metrics.

·         Manage, develop, and hire personnel in clinical development in support of therapeutic teams that design optimal clinical development plans and protocols.

·         Participate in the Protocol Approval Committee.

·         Participate in the development of the strategic plan for acquisition and clinical development of new products in the company’s pipeline.

·         Lead the clinical contribution to regulatory filings for approval of new drugs, new indications, or revision of product labeling.  Handle and respond to information requests from regulatory agencies.  Contribute clinical information to annual NDA reports, annual IND reports, investigator brochures, and other submissions to regulatory agencies.

·         Create and manage effective internal and external relationships with members of the BOD, SAB, CROs, regulatory agencies, partners, KOLs, etc.

·         Work closely with the CMO and clinical team in the development of program level documents, including clinical sections of regulatory documents (e.g. Investigators’ Brochures, briefing books, submission dossiers, and responses to Health Authorities questions, PSUR, DSUR, etc.).

·         Work with Drug Safety team members and IRBs to troubleshoot any relevant issues, and keep team members advised of progress, issues, and results.

·         Review relevant lab data from all studies.

·         Coordinate effective compliance within Biostatistics, Clinical Development, Clinical Operations, Data Management, Medical Writing, and departments that interface with clinical study execution.

·           Responsible for implementation of integrated and comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs, and ensure a continued state of inspection readiness.

·           Participate in project planning; issues management/escalation/resolution; risk management; CRO/Vendor management; timeline, budget, and resource Management

·         Ensure clinical projects/programs are tracked and communicated to the executive team and appropriate functional groups in a consistent and timely manner.

·         Assist with NDA/BLA compilation and management.

 

 

Requirements:

 

Education/Experience:

 

·         MD or equivalent degree required.

·         Prior experience or sub-specialty training in Pain, Orthopedics, or Rheumatology is strongly preferred.

·         Significant experience in leadership role(s), which involved clinical development and operation in the pharmaceutical industry and drug development.

·         Hands-on experience advancing therapies through all major development milestones. 

·         Demonstrated career progression.

·         Prior experience working in a small/emerging company is strongly preferred. 

·         Ability to provide scientific and clinical expertise to a clinical development program and clinical strategies for a product to obtain regulatory approval.

·         Demonstrated ability to establish relationships with internal colleagues and external collaborators (e.g., investigators, KOL's/CROs) and represent the company in public (e.g., scientific conferences, partners).

·         Demonstrated ability in decision-making, influencing, leadership, and affecting change by using a collaborative approach.

·         Demonstrated ability to provide clear direction and bring out the best in individuals.

·         Excellent knowledge of relevant FDA regulations and guidelines for conducting clinical trials.

·         Must be science-and data-driven.

·         Demonstrated knowledge of quality assurance related to clinical trial implementation.

·         Must have a results-oriented work ethic and a positive, can-do attitude. Must be willing and able to be “hands on” and willing to “roll-up sleeves” and delve into details.

Personal Attributes:

 

·         High personal integrity.  Work with transparency and engender trust at all levels. 

·         Professional attitude, maturity, confidence, and credibility to advise and influence senior management.

·         Strong business acumen.

·         Highly intelligent and detail-oriented with an ability to think strategically and operationally on a wide range of issues in a solutions-oriented manner.

·         Patient centric and results-oriented working with tenacity to advance projects and deliver on pre-determined milestones.

·         Ability to work in a collaborative culture where the best ideas win regardless of their origin.

·         Persuasive, humble, inclusive, and resilient with a strong sense of urgency and entrepreneurial attitude.

·         Able to distill complex information into simple messages.

·         Comfortable with and experienced in presenting to board members, investors, potential partners, and company staff.

 

 

If you have the qualifications we seek for this exciting opportunity to join a well-respected leadership team, please email a copy of your resume with your contact information to us today.