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VP of Clinical Development

New York, NY 10022

Posted: 08/19/2024 Employment Type: Direct Hire/Perm Job Category: Clinical Development and Operations Job Number: 611072 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 350-400k **salary will be commensurate with experience 
  Job Summary: The Vice President of Clinical Development will report to the Chief Development Officer and be responsible for leading and managing the clinical development strategy from early clinical development to commercialization. The strong focus for this position is on Phase II through commercialization of products for the transplant and autoimmunity community. This role will require strong leadership, strategic planning, and cross-functional collaboration to ensure successful clinical trial execution and regulatory approval. This role also must be commutable to the NYC office. Responsibilities: Portfolio management and development strategy
  • Develop and manage product profiles and Clinical Development Plans; lead the design, development, and implementation of innovative clinical trials, from translational stage through global Phase 3 trials and registration.
  • Lead Clinical Development efforts with dynamic and creative but realistic approaches to drug development across multiple therapeutic areas and product modalities.
  • Apply state-of-the-art knowledge of disease mechanisms to selection of possible biomarkers, pharmacodynamic endpoints, and patient stratification considerations to support innovative clinical study designs for novel products.
  • Maintain the highest quality clinical programs, following GCP and ICH guidelines.
  • Manage timely reporting of safety signals to regulatory authorities and the generation of clinical study reports.
  • Lead clinical team to secure global regulatory approvals for pipeline products.
  • Review documents including protocols, IBs, informed consent forms.
  • Manage the writing of protocols, presentations, and publications (regulatory submissions, original articles, abstracts).
Strategic leadership:
  • Evaluate the balance between outsourcing and in-house approaches for the various Clinical Development needs and work closely with the VP Clinical Operations to make recommendations for the company’ strategy.
  • Provide strategic consultation and guidance to Research on decisions that have significant clinical components and implications.

Cross-functional collaboration:
  • Communicate regularly and effectively with senior leaders and across the R&D team
  • Maintain accountabilities for all relevant timelines and deliverables.
  • Collaborate closely with functional counterparts and colleagues to ensure tight strategic integration of product development plans across the Development function and to ensure coordination of these functions with Clinical Operations and Biometrics.
  • Influence internal and external audiences in a high impact, highly visible way.
  • Develops, inspires, and supports individuals and teams to perform at extraordinary levels and ensures that all are engaged, challenged, and committed. Promotes a culture of integrity and quality within the clinical development team and across the organization.

Requirements and qualifications:
  • Medical Doctor (MD), or non-US equivalent of MD is required.
  • Experience in clinical transplant or autoimmunity is required.
  • Strong analytical skills with a demonstrated ability to think critically and creatively. 
  • 8+ years in Phase II – Phase III clinical development
  • Ability to commute to the NYC office and/or ability to travel to NYC office
  • Ability and willingness to travel domestically and internationally 20%
  • Proven track record of successfully leading clinical development programs from Phase II through commercialization, including regulatory approvals.
  • Must have and be able to demonstrate a commercial perspective
  • Must have significant clinical development experience with a well-established track record of success across all phases of development.
  • Demonstrated experience with positive and successful cross-functional collaboration with internal and external stakeholders
  • Excellent communication and leadership skills; act as a player/coach with the willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment
  • Outstanding writing skills with a track record of publications; superb presentation skills.
  • Shows insightful thinking by developing creative approaches to processes and practices, products & solutions, services, business models & strategy.
  • Significant regulatory experience with INDs, CTAs, End-of-Phase 2 meetings and NDA/BLAs/MAA, both US and ex-US.
  • Experience having managed significant accelerations and challenges in clinical programs.
  • Comfortable working with Senior Executive Team, Board members, KOLs, regulatory bodies, and investors.
  • Experience working with biotech/pharma partner(s) and preferably prior membership of steering committees.
Preferred Qualifications
 
  • Experience in both small and large biotech and/or pharmaceutical companies

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.