ED/VP, Medical Science and Strategy - Respiratory - Remote

at  Thermo Fisher Scientific

JOB DESCRIPTION

The position requires proven abilities to drive both strategic and measurable business outcomes. The incumbent’s respiratory diseases track record expertise is required to be extensive and ensure recognition as peer of their Pharmaceutical Industry equivalents. This position is playing a key part in the future success of PPD clinical research business of Thermo Fisher Scientific, as it seeks to continue its track record of successful growth and expand Industry leading position in the respiratory diseases field.
Medical Science & Strategy physicians are subject matter experts who support sales for proposals and bid defenses, engaging clients senior medical / scientific leadership in discussions and training internal staff on medical and therapeutic requirements of the proposals.
The role comprises four major functions:

First, the incumbent is responsible for ensuring the highest possible quality of input into significant requests for proposals (RFPs), including:

• Development strategy and regulatory issues
• Drug class issues
• Protocol and indication considerations, including safety
• Team education on indication
• Interactions with clients physicians and / or clients pneumology area leaders prior to and during bid defenses
• Identifying business opportunities for PPD clinical research business

Secondly, the incumbent is responsible for supporting outstanding input into other areas of PPD clinical research business activities, including:

• Pro-active client engagement: peer-to-peer interactions with therapeutic area leaders and senior directors of companies whose portfolio contains drugs of business interest
• Strategic alliance development & support
• Client governance and advisory boards
• Through PPD’s consulting practice, the incumbent will provide Industry gold standard product development plans, and top-level design of clinical trial protocols that are required in the development plan.

Thirdly, the incumbent will be responsible for providing therapeutic and developmental expertise to internal teams, including:

• Indication specific trainings for clinical teams
• Guidance during clinical trials executions
• Investigator Brochure, clinical study report, NDA / MAA clinical packages development, and other regulatory briefing documents authoring and review
• Contribute to design and reporting of feasibility studies
• Liaise with investigators and KOLs
• Mentor and supervise clinical scientists

Finally, the incumbent will participate in multidisciplinary teams and working groups to contribute to innovative initiatives based in their specific knowledge, expertise and interest.

MINIMUM QUALIFICATIONS:

• MD or equivalent required.
• Certified pneumologist/pulmonologist with at least 5 years’ experience leading clinical development of at least one asset from discovery through registration.
• Prior experience working for a pharma/biotech organization is preferred.

KNOWLEDGE, SKILLS AND ABILITIES:

• Able to work in a matrix organization.
• Able to demonstrate the following key high-level high performance behaviors: decisive, customer driven, flexible thinking, smart-risk taking and continuous improvement.
• Leads, influences and motivates staff within and across departments.
• Strong in presenting and communicating complex information clearly.
• Able to deal with sensitive and confidential issues.
• Possesses a “can do” attitude and is capable of implementing and following through on activities / projects.
• Proficient in spoken and written English.
• Flexibility to travel domestically and internationally

PHYSICAL REQUIREMENTS:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Moderate mobility required.
• Occasional crouching, stooping, bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others, relates sensitive information to diverse groups both internally & externally.
• Ability to apply basic principles to solve conceptual issues.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.

First, the incumbent is responsible for ensuring the highest possible quality of input into significant requests for proposals (RFPs), including:

• Development strategy and regulatory issues
• Drug class issues
• Protocol and indication considerations, including safety
• Team education on indication
• Interactions with clients physicians and / or clients pneumology area leaders prior to and during bid defenses
• Identifying business opportunities for PPD clinical research busines

Secondly, the incumbent is responsible for supporting outstanding input into other areas of PPD clinical research business activities, including:

• Pro-active client engagement: peer-to-peer interactions with therapeutic area leaders and senior directors of companies whose portfolio contains drugs of business interest
• Strategic alliance development & support
• Client governance and advisory boards
• Through PPD’s consulting practice, the incumbent will provide Industry gold standard product development plans, and top-level design of clinical trial protocols that are required in the development plan

Thirdly, the incumbent will be responsible for providing therapeutic and developmental expertise to internal teams, including:

• Indication specific trainings for clinical teams
• Guidance during clinical trials executions
• Investigator Brochure, clinical study report, NDA / MAA clinical packages development, and other regulatory briefing documents authoring and review
• Contribute to design and reporting of feasibility studies
• Liaise with investigators and KOLs
• Mentor and supervise clinical scientist