Associate Director, Clinical Scientist

4 weeks ago

Boston, United States Barrington James Full time

Job Title: Director of Clinical Science, Cardiovascular


Reports To: Senior Director of Clinical Science


Company Overview: We are at the forefront of developing innovative therapies that address unmet medical needs. Our focus on cutting-edge biotechnological research and patient-centric treatments propels us to explore new frontiers in medicine.


Position Summary: The Director of Clinical Science will lead the strategic planning and execution of clinical research initiatives critical to the development of new medical treatments. The role requires a seasoned professional adept at navigating the complexities of clinical trials from inception to completion.


Core Responsibilities:

  • Clinical Strategy Development: In collaboration with the Therapeutic Area Head, devise and implement comprehensive clinical strategies for novel therapeutic assets. Ensure these strategies align with the broader goals of the company.
  • Trial Management and Oversight: Spearhead the management of clinical trials, liaising with operational leads to guarantee timely and successful achievement of trial milestones. Serve as the primary clinical authority throughout the project lifecycle.
  • External Collaboration and Representation: Represent the company's clinical interests in interactions with external parties, including academic leaders, industry partners, and regulatory bodies. Enhance the company's clinical and scientific standing through strategic partnerships and presentations.
  • Data Integrity and Analysis: Oversee the rigorous collection, evaluation, and interpretation of trial data to ensure accuracy and efficacy. Play a key role in the preparation of regulatory submissions and documentation, safeguarding data integrity.
  • Regulatory and Compliance Oversight: Ensure all clinical activities comply with global regulatory standards, including GCP. Maintain up-to-date knowledge of regulatory changes and adjust clinical practices accordingly.
  • Communication and Documentation: Lead the drafting and review of critical clinical documents and regulatory filings. Effectively communicate complex clinical data and trial outcomes to both scientific and non-scientific stakeholders.
  • Interdisciplinary Team Leadership: Collaborate extensively with interdisciplinary teams across the organization, including R&D, operations, and marketing, to ensure seamless integration of clinical development processes.


Competencies Required:

  • Excellent analytical and problem-solving skills, with a proven track record of overcoming clinical research challenges.
  • Strong leadership qualities and the ability to inspire and guide multidisciplinary teams.
  • Effective communication skills, capable of articulating complex clinical concepts and strategies to a variety of audiences.
  • High level of adaptability and flexibility in a fast-evolving industry landscape.


Qualifications:

  • An advanced degree in a medical or scientific field (MD, PhD, or equivalent).
  • At least 5 years of experience in Cardiovascular clinical research or clinical development within the pharmaceutical or biotechnology sector, encompassing all phases of clinical trials.
  • Extensive expertise in clinical trial design, regulatory requirements, and clinical strategy formulation.
  • Demonstrated experience in regulatory document preparation and submission, including INDs and NDAs.


Travel Requirements:

  • Occasional travel may be necessary.


Work Availability:

  • Must be available for a minimum of 5 hours per day during the hours of 8 AM to 5 PM Eastern Standard Time.


This role offers the opportunity to be at the cutting edge of clinical research in a highly dynamic and innovative environment, driving forward the development of life-changing treatments.

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