Person2Person, LLC
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| VP-Chief Medical Officer Based in Northern, NJ |
| Outstanding Contract opportunity with a global pharmaceutical Company focused on multiple therapeutic areas including Neurology, Oncology and Critical Care. They continue to move forward with an entry into biologics with the development of therapeutic antibodies and other such agents, which contributes to their innovate drug discovery process. Be a part of this global market leader! |
| SCOPE & DUTIES |
Outstanding growth opportunity with a world-class Specialty Pharmaceutical Company
Be a part of this exciting global leading Company !
Position Summary:
The North American Vice President and Chief Medical Officer will be responsible for providing strategic
direction and leadership for drug safety, local medical affairs operations, commercial regulatory affairs,
biostats as well as the medical affairs teams for both the Endo and the Neuro business areas. In this
capacity the position will design near and long term strategies and tactics that will protect and optimize
the companies’ products. The position will determine post approval clinical work that needs to be done,
will oversee the ESS and Medical Grant process, will ensure that state of the art commercial regulatory
support is provided and that all safety reporting obligation are met in a timely and effective manner.
The position will also serve to liaise with both the pre-approval regulatory group as well as the R&D
organization in order to provide a senior leadership bridge between these groups and the affiliate.
Primary Responsibilities
• Clinical, biostatistical and regulatory leadership for all Phase IV study programs; ability to work
collaboratively with Global Drug Development group co-located in New Jersey.
• Member of the Management Committee, which is responsible for setting the business strategy of
the North American affiliate and overseeing all operations of the affiliate.
• Responsible for strategy and operations of the Phase IV clinical activities, Medical Affairs
Operations, Commercial Regulatory group and Safety and Pharmacovigilance. Represents Company at
the highest level at FDA.
• Establish the medical affairs strategy and budgets for programs to support the Neurology and
Endocrinology franchise strategies as well as insuring compliant processes across Safety, Regulatory and
Clinical and Medical Affairs Operations. As Senior physician in the US, work seamlessly within the global
Medical Community encompassing the Office of the CMO, other regional medical heads, translational
medicine and Global Drug Development, insuring collaboration in the US when different groups working
with the same external physicians or investigators.
• Approve all medical synopses, medical protocols, investigator initiated study ideas and abstracts
and publications generated by the US group.
• Oversee all medical affairs processes including provision of medical information upon unsolicited
request, grants committee and requests for and approval of investigator initiated studies.
• Lead the therapeutic franchise field medical groups to insure compliant and medically appropriate
metrics are designed, implemented and followed.
• Lead the group in training on and insuring compliance with all applicable healthcare laws, in
conjunction with Chief Compliance Officer.
• Represent the Company as necessary to internal and external groups. Function or supervise
others as an expert liaison between Company and leading academic specialists.
• This job has [7] direct reporting positions at present. However, as they expands its operations
this position will have increased supervisory responsibility. This involves hiring talented staff and
managing effective performance, by providing feedback, coaching and development opportunities.
Be a part of this exciting global leading Company !
Position Summary:
The North American Vice President and Chief Medical Officer will be responsible for providing strategic
direction and leadership for drug safety, local medical affairs operations, commercial regulatory affairs,
biostats as well as the medical affairs teams for both the Endo and the Neuro business areas. In this
capacity the position will design near and long term strategies and tactics that will protect and optimize
the companies’ products. The position will determine post approval clinical work that needs to be done,
will oversee the ESS and Medical Grant process, will ensure that state of the art commercial regulatory
support is provided and that all safety reporting obligation are met in a timely and effective manner.
The position will also serve to liaise with both the pre-approval regulatory group as well as the R&D
organization in order to provide a senior leadership bridge between these groups and the affiliate.
Primary Responsibilities
• Clinical, biostatistical and regulatory leadership for all Phase IV study programs; ability to work
collaboratively with Global Drug Development group co-located in New Jersey.
• Member of the Management Committee, which is responsible for setting the business strategy of
the North American affiliate and overseeing all operations of the affiliate.
• Responsible for strategy and operations of the Phase IV clinical activities, Medical Affairs
Operations, Commercial Regulatory group and Safety and Pharmacovigilance. Represents Company at
the highest level at FDA.
• Establish the medical affairs strategy and budgets for programs to support the Neurology and
Endocrinology franchise strategies as well as insuring compliant processes across Safety, Regulatory and
Clinical and Medical Affairs Operations. As Senior physician in the US, work seamlessly within the global
Medical Community encompassing the Office of the CMO, other regional medical heads, translational
medicine and Global Drug Development, insuring collaboration in the US when different groups working
with the same external physicians or investigators.
• Approve all medical synopses, medical protocols, investigator initiated study ideas and abstracts
and publications generated by the US group.
• Oversee all medical affairs processes including provision of medical information upon unsolicited
request, grants committee and requests for and approval of investigator initiated studies.
• Lead the therapeutic franchise field medical groups to insure compliant and medically appropriate
metrics are designed, implemented and followed.
• Lead the group in training on and insuring compliance with all applicable healthcare laws, in
conjunction with Chief Compliance Officer.
• Represent the Company as necessary to internal and external groups. Function or supervise
others as an expert liaison between Company and leading academic specialists.
• This job has [7] direct reporting positions at present. However, as they expands its operations
this position will have increased supervisory responsibility. This involves hiring talented staff and
managing effective performance, by providing feedback, coaching and development opportunities.
| REQUIREMENTS |
MD with a minimum of 8 years experience in pharmaceutical or biotechnology company.
• Must have significant, highly relevant pharmaceutical experience in Medical Affairs, including
design and oversight of Phase IV clinical studies, medical affairs services such as medical information,
grants processing, investigator-initiated trials, field medical management and KOL management, and
publication processes and execution.
• Must have working knowledge of safety reporting and commercial regulatory affairs including
promotional review.
• Previous experience working with specialty pharmaceuticals a plus.
• Previous experience working in Endocrinology or Neurology particularly in toxin arena within
industry preferred but not required.
• Experience in health economic assessments and market access strategies a plus.
• Experience working with a non US headquartered company not critical but a plus
• Must have significant, highly relevant pharmaceutical experience in Medical Affairs, including
design and oversight of Phase IV clinical studies, medical affairs services such as medical information,
grants processing, investigator-initiated trials, field medical management and KOL management, and
publication processes and execution.
• Must have working knowledge of safety reporting and commercial regulatory affairs including
promotional review.
• Previous experience working with specialty pharmaceuticals a plus.
• Previous experience working in Endocrinology or Neurology particularly in toxin arena within
industry preferred but not required.
• Experience in health economic assessments and market access strategies a plus.
• Experience working with a non US headquartered company not critical but a plus
| Executive Recruiting Specialists in the NY/NJ/CT Region |
Apply today! For immediate consideration, please email resume to: lsydor@person2personllc.com |