Senior Director of Clinical Development

Senior Director of Clinical Development

The Opportunity:

We are seeking an experienced clinical science drug developer to serve as Senior Director of Clinical Development in support of clinical-stage molecule(s). In this critical role, you will support various clinical science deliverables and enable effective and efficient execution of the clinical development plan for a molecule(s) within its particular indication(s). The scope of activities spans early-stage clinical research to pivotal studies including regulatory submissions. You will play a vital role in leading the clinical science aspects of the Clinical Development Plan (CDP) strategy, driving the development of transformative therapies for patients.

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  Lead clinical science aspects of the clinical development strategy and clinical documentation.
  Represent the clinical development plan on appropriate teams, sub-teams and forums; oversee training of study site personnel, act as primary point-of-contact for questions/enquires regarding the CDP at a program level, oversee the conduct of medical/safety data reviews and study reporting
  
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  Potential assignment to complex and high-priority strategic studies, with expectation to perform responsibilities with independence and clear self-directed leadership
  
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  Cross-functionally align efforts seamlessly with scientific, regulatory, and commercial objects while executing upon the clinical development plan
  
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  Lead, mentor, and contribute to a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence.
  
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  Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance.
  
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  Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions and guide program development.
  
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  Manage clinical development timelines effectively, ensuring and achievement of milestones.
  
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  Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development.
  

Required Skills, Experience and Education:

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  Bachelor’s Degree (life sciences preferred) plus Advanced Clinical/Science Degree is required (e.g., PharmD, PhD, MSN, MPH, etc.).
  
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  Minimum 6+ years experience in clinical development required (Pharma R&D experience outside of a clinical development role also considered pending transferability of skills and responsibilities)
  
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  Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry
  
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  Experience in independent generation of trial design, protocol writing/ICF (writing or amendment), constructing appropriate CRF and coordinating cross-functionally
  
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  In-depth therapeutic area experience/expertise, and relevant clinical trial experience (or clear ability to adapt with transferable skills)
  
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  Strong knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulations is required
  
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  Proven ability to work effectively and efficiently within cross-functional teams involved in the drug development process; proven ability to efficiently integrate multiple perspectives into the CDP
  
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  Experience authoring regulatory briefing packs, write responses to Health Authority questions, and proven ability to contribute to strategic approach and cross-functional coordination in support of regulatory activities/interactions
  
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  Demonstrated success in driving various aspects of cross-functional study level strategy, e.g. study design, supporting feasibility and timelines/budget projections, protocol amendment requirements. Ability to drive relevant discussion at key internal decision-making bodies/governance.
  
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  Experience in (or clear ability) investigator engagement to optimize clinical trial conduct. Includes presenting at investigator meetings
  
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  Strong orientation to teamwork. Excellent leadership, communication, and interpersonal skills with the ability to inspire, motivate and mentor across a diverse team.
  
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  Expertise in building and maintaining strong relationships with internal and external stakeholders.
  
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  Superb strategic thinking and analytical skills, with the ability to make data-driven decisions in a fast-paced environment. Able to recognize trade-off decisions and can determine priorities and goals.
  
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  Strong written and business presentation skills is required.
  
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  Passion for innovation and a commitment to developing therapies that make a meaningful difference in patients' lives.
  
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  Has demonstrated adaptability and flexibility
  
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  Anticipates needs, assesses and manages business and organizational risks
  

Preferred skills:

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  Has made significant contributions to clinical development plan conception, conduct and delivery, including successful alignment with scientific governance
  
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  Experience in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources in the pharmaceutical/biotech industry
  
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  Has led clinical development contributions to major regulatory submissions (e.g. (s)NDA, (s)BLA, PIP/PSP, label negotiation, Breakthrough Therapy Designation, Accelerated Review) is a major plus.
  
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  Proven ability to present the clinical development aspects of a program(s) to key major reference health authorities (FDA, EMA, others.) by teleconference or in-person
  
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  Has led Health Authority interaction(s)
  

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  Proven ability to set out the clinical development strategy for CTA/EC submissions and responses to health authority questions
  
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  Has demonstrated collaborate behaviors on enterprise-level strategic initiatives with a variety of internal and external partners and stakeholders - including clinical investigators/clinicians, scientists and key opinion leaders (KOLs), as well as internal groups, including other groups in development, research, business development, commercial, legal, etc. - resulting in demonstrable outcomes that have further enhanced strategic goals.
  
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  Influential and inspiring leader, with proven ability to bring teams and individuals along with them.
  
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  Has demonstrated courage and conviction in past positions and responsibilities. Demonstrated skills in conflict resolution.