Associate Director, Clinical Scientist

3 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.

  • Senior Clinical Scientist

    3 weeks ago

    Boston, United States Verve Therapeutics Inc Full time

    The Position Verve is seeking an experienced Senior Clinical Scientist to join our team as we continue to advance gene editing medicines for cardiovascular disease into clinical development. In this position, you will be an integral part of the clinical development team supporting the execution of early phase clinical studies. You will report to the Senior...

  • Associate Director, Clinical Pharmacology

    1 month ago

    Boston, Massachusetts, United States Fusionpharma Full time

    Associate Director, Clinical Pharmacology/DMPK Management Boston, MA, USFusion is looking for an Associate Director, Clinical Pharmacology/ DMPK to join non-clinical development group.The successful candidate must have experience and foundational knowledge and experience in clinical pharmacology, drug metabolism, pharmacokinetics, bioanalytical and PK/PD...

  • Senior Clinical Data Scientist

    5 days ago

    Boston, United States whoop Full time

    WHOOP is an advanced health and fitness wearable, on a mission to unlock human performance. WHOOP empowers its members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives.As a Senior Data Scientist on the Health Data Science team, you’ll help develop technology at the core of the business. In...

  • Senior Clinical Data Scientist

    5 days ago

    Boston, United States Whoop Full time

    WHOOP is an advanced health and fitness wearable, on a mission to unlock human performance. WHOOP empowers its members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives. As a Senior Data Scientist on the Health Data Science team, you'll help develop technology at the core of the business. In...

  • Associate Director, Clinical Project Lead

    3 weeks ago

    Boston, United States Alexion Pharmaceuticals, Inc. Full time

    Associate Director, Clinical Project Lead This is what you will do: The Associate Director, Clinical Project Lead is responsible to lead the Cross-Functional Clinical Sub-Teams to define study specifications, achieve study milestones through operational feasibility and budget and timeline estimates and operational accountability and management of study...

  • Associate Scientist, Protein Engineering

    1 month ago

    Boston, Massachusetts, United States Proclinical Staffing Full time

    Senior Associate Scientist, Protein Engineering & Bioconjugation - Permanent - OnsiteProclinical is seeking a Senior Associate Scientist, Protein Engineering & Bioconjugation to join a stealth biotech company.The Senior Associate Scientist will be a motivated and curious researcher, with willingness to learn about numerous areas of bioconjugation, chemistry...

  • Associate Director, Clinical Pharmacology

    1 month ago

    Boston, Massachusetts, United States Fusion Pharmaceuticals Full time

    Fusion is looking for an Associate Director, Clinical Pharmacology/ DMPK to join non-clinical development group.The incumbent will be responsible to lead and execute clinical pharmacology/ DMPK strategies and studies for early through late-stage clinical development programs.The successful candidate must have experience and foundational knowledge and...

  • Associate Director Clinical Operations

    3 weeks ago

    Boston, United States Biotech Full time

    Location: Boston, MA (Relocation package available)Company Overview: Join a pioneering oncology biotech company based in the vibrant Boston biotech community. Their mission is to revolutionize cancer treatment through innovative research and the development of cutting-edge therapies.Role Overview: We are seeking a strategic and experienced Associate...

  • Associate Director Clinical Operations

    1 week ago

    Boston, United States Biotech Full time

    Location: Boston, MA (Relocation package available)Company Overview: Join a pioneering oncology biotech company based in the vibrant Boston biotech community. Their mission is to revolutionize cancer treatment through innovative research and the development of cutting-edge therapies.Role Overview: We are seeking a strategic and experienced Associate...

  • Associate Director Medical Affairs

    2 weeks ago

    Boston, United States Advanced Clinical Full time

    Associate Medical Director in Medical Affairs Hybrid - on site part-time Boston, MA PERM - Fulltime PharmD or PhD preferred ** Motivated and ready to take on the Strategy of Medical Affairs team** Responsibilities and Duties Work in close collaboration with Field Medical, Global Medical Affairs, Commercial, Customer Engagement, and other cross-functional...

  • Associate Director, Clinical Operations

    2 days ago

    Boston, United States X4 Pharmaceuticals INC Full time

    **Associate Director, Clinical Operations** **Reporting to**: _Senior Director, Clinical Operations_ Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear and profound impact on patients suffering from rare diseases? Does it excite you to be a part of a patient-focused company developing potential...

  • Associate Director Medical Affairs

    1 week ago

    Boston, United States Advanced Clinical Full time

    Associate Medical Director in Medical AffairsHybrid - on site part-timeBoston, MAPERM - FulltimePharmD or PhD preferred** Motivated and ready to take on the Strategy of Medical Affairs team**Responsibilities and Duties• Work in close collaboration with Field Medical, Global Medical Affairs, Commercial, Customer Engagement, and other cross-functional...

  • Associate Director Medical Affairs

    2 weeks ago

    Boston, United States Advanced Clinical Full time

    Associate Medical Director in Medical AffairsHybrid - on site part-timeBoston, MAPERM - FulltimePharmD or PhD preferred** Motivated and ready to take on the Strategy of Medical Affairs team**Responsibilities and Duties• Work in close collaboration with Field Medical, Global Medical Affairs, Commercial, Customer Engagement, and other cross-functional...

  • Associate Director Medical Affairs

    3 weeks ago

    Boston, United States Advanced Clinical Full time

    Associate Medical Director in Medical AffairsHybrid - on site part-timeBoston, MAPERM - FulltimePharmD or PhD preferred** Motivated and ready to take on the Strategy of Medical Affairs team**Responsibilities and Duties• Work in close collaboration with Field Medical, Global Medical Affairs, Commercial, Customer Engagement, and other cross-functional...

  • Director, Pharmacovigilance Scientist

    3 weeks ago

    Boston, United States Verve Therapeutics Inc Full time

    The Position Verve is seeking a director level pharmacovigilance (PV) Scientist. This is an individual contributor role and an exciting opportunity to be on the ground floor of a developing PV department working on cutting-edge therapies. This role will provide day-to-day oversight of safety monitoring activities and safety operations as well as management...

  • Associate Director Translational Biomarker Lead

    5 days ago

    Boston, United States ARIAD Full time

    **Job Level**: Senior**Travel**: Minimal (if any) Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to...

  • Associate Director of Clinical Pharmacology

    6 days ago

    Boston, United States Invenia Group Full time

    Invenia Group is partnered with an exciting AI-powered clinical-stage biotech company, headquartered in the US, which is seeking an Associate Director of Clinical Pharmacology to oversee and lead the clinical pharmacology team. This position requires a strong scientific background, exceptional leadership skills, and a thorough understanding of the drug...

  • Associate Director Translational Biomarker Lead

    5 days ago

    Boston, United States ARIAD Full time

    **Job Level**: Senior**Travel**: Minimal (if any) Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to...

  • Associate Director/Director, Clinical Programming

    3 days ago

    Boston, United States Xenon Inc Full time

    Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and...

  • Principal Research Associate/Associate Scientist, Cell Biology

    3 weeks ago

    Boston, United States Magnet Biomedicine Full time

    Principal Research Associate/Associate Scientist, Cell Biology About Magnet Biomedicine Magnet Biomedicine is a fast-paced, collaborative, venture-backed startup developing rational approaches to molecular glue discovery. Magnet's TrueGlueTM Discovery Platform enables the discovery and development of fit-for-purpose molecular glue strategies to target a...