Job Description
We have an exciting opportunity for a physician-scientist to join our group as a Principal Scientist (Clinical Director) in Translational Medicine/Early Clinical Development in the Cardiovascular and Respiratory Therapeutic Area based in the US (Boston, MA).
Translational Medicine at our Research Division is responsible for early clinical development of novel therapeutics, working in close collaboration with our discovery scientists and late-stage clinical researchers in all therapeutic areas. The Cardiovascular and Respiratory Therapeutic Area specifically focuses on development in the fields of cardiology, pulmonology, and related fields such as vascular medicine and nephrology. We are seeking a highly qualified individual for a position in our group. Success depends on the integrity, knowledge, imagination, creativity, skill, diversity and teamwork of the people in the group. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. Candidates should have a strong background in basic, translational, and/or clinical research and a desire to work collaboratively across the organization between departments and therapeutic areas as part of a global team.
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Primary responsibilities for the Principal Scientist include the following:
- Working with basic science teams on specific diseases and therapeutic areas, providing clinical expertise for identification and validation of novel targets, including the design of preclinical and clinical experiments to validate targets and/or pathways, and leveraging this work for development of novel therapeutics
- Working with cross-functional teams including discovery scientists, pharmacologists, toxicologists, and other specialists to advance novel therapeutics from preclinical development into clinical development
- As a key member/leader of an early development team, working in close collaboration with internal and external staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations) for the design and execution of early clinical development strategy
- Taking a lead role in developing and executing clinical pharmacology studies for programs in all phases (I - IV) of development, including formulation or device changes, drug-drug interaction studies, and studies in special populations
- Providing early phase/clinical pharmacology support for programs through the regulatory filing process including preparation of supportive documents and presentations
- Developing and executing studies to validate established and novel clinical biomarkers, including blood/tissue sampling, imaging, electrophysiological, wearable devices, and behavioral responses to study biological activity in humans
- Providing clinical and scientific expertise to assess internal and external opportunities for partnership
- Engaging with the broader internal and external scientific community in disease or therapeutic areas of interest, including via consultations with scientific/academic thought leaders, preparation of posters and publications, and attendance/presentation at conferences
- Working broadly with key functions across the company at research sites around the world.
Translational Medicine is specifically responsible for:
- Contributing to the identification of novel targets by partnering with Discovery Sciences to bring a clinical perspective into the earliest stages of target identification and validation, and to execute clinical studies to evaluate the relevance of potential targets to human disease in order to justify full development.
- Leadership of the early clinical development strategy for novel therapeutic programs from the preclinical stage through Phase 1 studies of safety, tolerability, pharmacokinetics and pharmacodynamics, to Phase 2 studies demonstrating Proof-of-Concept and enabling Phase 3 clinical trials.
- Development of biomarker strategies through cross-functional teams that advance therapeutics from First-in-Human studies through clinical Proof-of-Concept. This includes experimental medicine studies to establish and/or validate biomarker platforms.
- Development and execution of clinical pharmacology strategies to support later stages of development through to worldwide regulatory applications.
Education:
- Doctoral degree: MD or MD/PhD (or international equivalent)
Required:
- Experience in biomedical research, with a demonstrated record of scientific scholarship and achievement including scientific publications. The specific clinical or scientific background is less important than having a track record of excellence and a willingness to work collaboratively across different therapeutic areas.
- Strong interpersonal, writing, and presentation skills, as well as the ability to function in a team environment, are essential.
- Experience in clinical medicine including completion or anticipated completion of residency/fellowship training is preferred, including Clinical Board Certification.
- Experience as an academic faculty member is preferred. Fellowship training in Cardiology, Pulmonology, or Nephrology is preferred but not required.
- Prior experience in the pharmaceutical industry is helpful but not required.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
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Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
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Job Posting End Date:
11/29/2024
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Requisition ID:R301552