Nonclinical Drug Safety (NDS), Therapeutic Area Leader, Infectious Disease Program Development - Distinguished Scientist
The Distinguished Scientist, Nonclinical Drug Safety (NDS) Therapeutic Area is a scientific executive leader with responsibilities that include but are not limited to the following:
The role serves as a Therapeutic Area Leader in NDS within the specified therapeutic area(s) of interest to our company to oversee the progression of nonclinical development programs and post-marketing support. The role will include responsibilities in the Infectious Disease (Antivirals/Antibacterials/Antifungals/Antiparasitics, etc.) Therapeutic Area.
Providing scientific and strategic oversight for all development candidates within this area, through close collaboration with Program Coordinators and Compound Leaders (program team representatives) from various functional areas within NDS, Preclinical Development and, as needed, across other areas such as (biology, chemistry, clinical, etc) or external partners.
Provide strong drug development mentorship and partnership in problem solving with Compound Leaders on diverse time critical drug development matters including design of nonclinical program/ studies to appropriately support clinical trials as well as ongoing oversight of nonclinical safety and development strategy, successful issue identification and resolution.
Responsible for high-quality nonclinical risk assessments and regulatory documentation that support solid submission components including clear and concise descriptions of experimental details, interpretations and robust risk assessments for IBs, CTAs, IND, NDA, MAA, regulatory responses and other legal/scientific documents to support global clinical trials and registration.
Close collaboration with the Infectious Disease Discovery group and interface with Discovery Program Leaders in NDS, providing scientific and strategic input on discovery projects within this therapeutic area.
Contributes to global nonclinical development strategy through scientific publication and/or participation on external consortia and collaborations and proactively initiates and leads internal cross-departmental initiatives to improve policies, procedures, and/or strategic direction to ensure our company is a leader in nonclinical drug development.
The incumbent may also serve as a Compound Leader for their own development compound(s) and may be responsible for overseeing and/or conducting NDS due diligence reviews for in-licensing compounds within the Infectious Disease Therapeutic Area.
PhD, DVM, and/or MD Degree with graduate and/or post-graduate work and/or residency training in Toxicology, Pharmacology, Pathology, or a related field.
Required Experience and Skills:
Minimum experience of 10 years in Toxicology, Pharmacology, Pathology or related field with either extensive pharmaceutical Program Team experience and demonstrated expertise in nonclinical drug development and/or extensive regulatory experience with a Health Authority in a related field.
Previous experience supervising and/or mentoring program team representatives
Solid experience with regulatory processes, risk assessments and ICH guidelines and Good Laboratory Practice (GLP).
Demonstrated experience and expertise in nonclinical drug development including discovery, development through post-marketing; strong preference for previous experience in infectious disease drug development as either a program team representative and/or scientific oversight for this Therapeutic Area.
Strong scientific acumen, passionate and persistent with a track-record of success in various phases of drug development.
Strong leadership skills and ability to work to maintain effective interactions in matrixed environment; ability to collaboratively influence strategic direction; leadership style creates a balanced culture of mentorship, empowerment and accountability achieving talent growth and program success.
Efficient organizational skills and excellent verbal and written communication skills.
Experience in writing nonclinical sections of relevant nonclinical regulatory documents (IBs, briefing book, BLA’s, NDA’s, regulatory responses etc).
Preferred Experience and Skills:
Previous experience in Infectious Disease drug development
Experience across multiple modalities
Well recognized in area of expertise; significantly contributed to global regulatory strategy through scientific publication and/or participation on external consortia/collaborations
Previous experience on product development team(s)
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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Expected salary range:$193,440.00 - $304,500.00
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