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Senior Medical Director, Clinical Development

This unique opportunity reporting to the Vice President, Clinical Development will have a significant role in developing life transforming therapeutics for patients with rare diseases. Looking for a capable, insightful, practical, experienced and skilled physician leader to help plan, develop, execute and analyze clinical study programs in rare bone diseases. The best candidate can manage appropriate protocol development, endpoint development and effective reporting of results, adequate monitoring and management of clinical studies of designed to support regulatory submissions seeking market approval in the US and worldwide. ¬ In this role you will interface with academic clinicians to effectively evaluate protocol strategies and publication to support product claims and marketing requirements. ¬ The incumbent will also participate in strategic planning and product development functions as necessary.¬ One major responsibility will be serving as the physician lead for the Disease Monitoring Programs (DMP) for rare bone diseases.¬ The DMPs are designed to be innovative, cutting edge research studies combining both in-clinic assessments and on-line patient reported experiences over a 10+ year time period.¬ The DMPs will be the main data generation initiatives supporting our products through their life cycle.
¬
Looking for an experienced physician with the passion and creativity to develop great medicines for rare and ultra-rare diseases. ¬ The individual will be a self-starter with excellent clinical capabilities and who is seeking to be part of an innovative team that will drive the drug development processes from start to finish. The successful candidate will be ready for a career defining experience and have the passion to drive a number of therapeutics for devastating diseases to final approval.¬
Responsibilities including, but not limited to:
  • Manage the process for the company's clinical studies effort to ensure the highest level of success, efficiency of clinical protocols, FDA review and successful product launches
  • Successfully lead cross-functional teams focusing on clinical development strategy
  • Be an effective manager of physician scientists and/or clinical science specialists
  • Direct and oversee clinical studies, including clinical strategy and design, protocol writing, Institutional Review Board (IRB) applications, training, monitoring, documentation and data analysis
  • Work with current and future partners to initiate and monitor clinical studies including evaluation
  • Reviews and Approves procedures for the design and implementation of clinical protocols, data collection systems and final reports
  • Ensure that all clinical studies are appropriately designed and effectively executed and monitored
  • Provides safety surveillance guidance, acts as a medical monitor, ¬ and ensures adherence to cGCP requirements and all applicable regulatory references and guidelines
  • Participate in pre-submission, pre-market and other meetings with the FDA and other regulatory agencies, as needed
  • Manage outside consultants (consultants, etc.) to ensure data is accurately collected and analyzed in a cost effective fashion¬
  • Exhibits leadership skills within and outside of the organization (including people skills, mentoring, presentation skills and professional interaction)
  • Take a leadership role in proposal development to identify effective clinical and regulatory implementation strategies that are efficient in time and money, and hedge risk as needed. ¬
  • Review and approve proposals for appropriate personnel assignments, time allocations, and budgets
Technical Requirements & Skills:
  • MD degree or MD, PhD degrees, graduating from a high quality medical school.
  • Minimum of 4 years of industry experience (rare disease experience preferred but not required)
  • Must have completed clinical training in a quality clinical residency program, be licensed in at least one state in the US
  • Must be originally boarded in a medical speciality; optimally in medical genetics, pediatric or adult neurology or other complex clinical fields dealing with chronic diseases and complex pathophysiology, or relevant experience.¬
  • Must be trained in GCP regulations, and be familiar with relevant ICH and FDA guidelines relevant to clinical development. Must have experience designing successful clinical studies in complex diseases requiring the management of patient variation, chronic irreversible disease and related complexities. Must be facile with statistical issues and be able to manage working with a statistician to design the analysis of clinical studies
  • Experience across all phases of clinical studies required, understanding and/or experience with post-approval commitments is an advantage
  • Ability to write clinical study reports and summaries for regulatory purposes¬
  • Thought about adding something in support of DMPs and or other post-marketing initiatives.
People Management Skills:
  • Clarify Direction & Priorities: Set clear direction for your direct reports aligned with functional and corporate goals. Reprioritize work, as needed. Enable others to do their job well by communicating information and making decisions in a clear, timely manner.
  • Partner & Collaborate Effectively: Listen to and value others‚ thoughts and ideas. Demonstrate effective partnership both within and outside your team. Achieve results with and through others.
  • Support Learning & Growth: Demonstrate self-awareness, humility, and curiosity in service of self-development. Provide regular coaching and feedback that will inspire growth and improvement in others.¬


Company Description:

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