Clinical Development Osteoarthritis

Biotech, Therapeutic Head, Clinical Development, Osteoarthritis

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If you have a medical degree, 10+ years of current clinical development experience and a heavy background in Osteoarthritis, this may be the next best step for you! We are looking for dynamic leaders who want to work in a cutting edge environment and want to create impact in a company working to make a difference. If you are interested, please send a resume for immediate and confidential consideration, and note where you heard of the opportunity.

Summary
The Therapeutic Head, Clinical Development, Osteoarthritis will be instrumental in supporting the growth of the company's Osteoarthritis portfolio as the organization continues to build the value of the current products and develop new products. This person will have hands-on responsibility leading the clinical development team, designing and executing clinical trials, and running programs focused on Osteoarthritis, and will exhibit a passion for Phases 1 through 3, including biomarkers, proof-of-concept and full development. This position offers potential growth opportunities to the right candidate possessing a combination of intellectual and execution skills and a love of the science.

Requirements to apply for this role:

•  MD required.
• 10+ years of current in-house pharma / biotech experience, including leading a Clinical Development team.
• Strong background in Osteoarthritis, Orthopedics, or Degenerative Disc Disease.

Duties and Responsibilities

• Manage the development and execution of high-quality, cross-functional, clinical trial plans, to apply trial management practices in the development, initiation, planning, execution, control, and closing of trials, and to serve as training and a support resource to the Clinical Operations team.
• Provide information on resource requirements to Project Management, Clinical Operations and other groups as required (e.g., clinical trial supplies, budgets, laboratory requirements).
• Liaise with and provide information to regulatory affairs as required. Manage the development of clinical trials and support/provide clinical site management during the course of clinical trials.
• 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, GCP, and good medical practice.
• Ensure clinical projects/programs are defined, tracked and communicated in a consistent and effective manner.
• Define and develop governance standards specifically for conducting clinical trials including: Project Planning/Tracking; Status Reporting; Issues Management/Escalation/Resolution; Risk Management; CRO/Vendor Management; Financial Management and Resource Management.
• Ensures continued utilization and maturation of best practice trial management standards and methodologies.
• Helps ensure the growth and success of CRAs and project leaders and their teams by providing mentoring and training, established clinical trial processes, policies and procedures, as well as tools and templates. Build and maintain cross-functional relationships.
• Work with QA departments to perform audits of clinical trials and create clinical processes and methodologies related to achieving / supporting GCP and FDA compliance.
• Help in the development and preparation of study manuscripts for intended publication.
• Represent the company in public forums (e.g., scientific conferences, advisory committees).
• Design and optimize clinical trial design and ensure clinical trials meet ethical and regulatory standards.
• Lead the Clinical Development Team, including interactions with discovery, safety, marketing, regulatory, research and other functions.
• Work with Therapeutic Area Head and other team members to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections).
• Assist senior management to oversee quality, coordination and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISS's, ISE's, and clinical expert reports.
• Present and discuss data and findings at relevant team, governance, KOL and regulatory meetings.
• Establish and maintain working relationships with Study investigators, key opinion leaders, academicians, and senior managers and department heads across the corporation.
• Ensure adherence to GCP/ICH and Standard Operating Procedure (SOP) standards.

Requirements

• MD required. 10+ years of current pharma / biotech industry experience with strong background in Osteoarthritis.
• Global experience within all phases of drug development with advanced understanding of other functions; including but not limited to: Research, Non-Clinical, Manufacturing / Supply Chain, Commercial, Regulatory and Medical Affairs.
• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
• Experience in designing Clinical trial strategies to obtain regulatory approval.
• Ability to provide scientific and clinical expertise to a clinical development program and evaluate scientific and clinical strategies for a product.
• Application of Project Management tools, methodologies, practices, risk analysis, decision analysis and contingency planning.
• Ability to establish relationships with external individuals/organizations (e.g., investigators, KOL's/CROs) and represent the company in public (e.g., scientific conferences, advisory boards).
• Ability to identify realizable solutions and alleviate potential hurdles in unique clinical trial situations to ensure trial success.