Job Code:
Location: Mid-West

This is a leadership position in the part of the business which provides front line contact with the US healthcare community, including thought leaders, advisors, professional societies, advocacy groups, decision-makers, payers, and the broader clinical community. The position plays a key role in meeting the immediate and future needs of the US clinical and scientific community by providing prompt, high quality, and insightful answers to questions around products and research. He/she will provide significant feedback internally to help company understand the external environment and provide key insights to the company’s drug development programs.

The person in this role will provide senior scientific and clinical leadership to the organization by facilitating and enhancing our interface with the relevant thought leaders, professional community, and advocacy groups He/she will be a member of the US therapeutic leadership team and provide medical input into the overall short and long-term strategy. As well, this individual will contribute directly to key initiatives, such as the clinical research program, publication strategy and execution and interface with key external decision-makers, including regulatory agencies. Finally, this individual will provide critical late phase and marketplace insights to the drug development teams and contribute to the corporate long-term strategy in the therapeutic area.

Expectations:

Within six months, the external thought leader community will acknowledge this individual as a key therapeutic medical leader. The individual will demonstrate a solid understanding of company internal structures and processes and will influence strategy and implementation at all levels and across the development chain.

After two years, the individual will have enhanced their internal and external network, their knowledge of the therapeutic area, and the company’s research and development programs in the relevant therapeutic area(s). He/she will provide direct leadership to key internal initiatives in areas such as advisory boards, research programs, publications, protocol design, and strategic programs. They will be fully integrated as a member of the corporate therapeutic leadership team and a key contributor to decisions around lifecycle management of our products, key development milestones, and development of the pipeline.

Over their career, the individual may elect to move to a different part of the drug development chain to continue their personal and professional growth.

Detailed activities and responsibilities:

+ New Product Development, Registration, Launch, and Commercialization

The primary responsibilities are generally related to late-phase and marketed compounds. However, the role provides the opportunity to support Corporate/Global studies conducted in the US. In such cases, the incumbent will:

Represent local needs to Late Phase and Early Phase teams in the development and maintenance of the product life plan.
Represent the clinical and regulatory needs of the US Affiliate to Late Phase and Early Phase teams in the development of clinical strategies, development plans, and study protocol design.
· Work with local clinical research staff in the startup and conduct of corporate decision phase, registration phase, and commercialization phase studies that are conducted in the US:

· Participation in data analysis, developing the scientific disclosure strategy, and preparation of final reports and publications

· Planning of and participation in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel


+ Commercialization Trial Support for Marketed Products
· Become familiar with market archetypes and potential influence on the clinical trial strategy for the product.

· Integral member of US team in contributing to the Global Medical Planning process.

· Participating in data analysis, preparation of final reports, and publications.

· Working with local clinical research staff in the design and conduct of local commercialization support studies.

· Participating in study planning, e.g., with respect to sample size/patient commitment, timelines, grants, and site selection.

· Planning and participation in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.



Market Support
· Become familiar with market archetypes and potential influence on the medical interventions for the product.

· Contribute to the development of medical strategies to support brand commercialization activities by working closely with brand teams, clinical plans manager/team leader and other cross-functional management during the development of the local business plan.

· Participating on an ongoing basis in strategic planning for the brand.

· Must understand and keep updated with the pre-clinical and clinical data relevant to the molecule.

· Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product.

· Must be aware of current trends and projections for clinical practice in the therapeutic area(s) relevant to the product.

· Supporting business-to-business and business-to-government activities as medical expert.

· Participating in advisory committees, and other professional relations activities.

· Advisory Board agenda planning and participation.

· Establishing and maintaining contacts with external experts, thought leaders, and the general medical community on a national and possibly international basis.

· Developing and maintaining productive relationships with relevant professional societies.

· Promotional speakers.

· Supporting training of local medical personnel, including medical liaisons and health outcomes staff.

· Scientific and creative support for promotional literature and materials for brand team.

· Meeting thought leaders and participation in customer events.


+ Regulatory

· FDA contact – critical regulatory interaction


+ Medical Information
Supporting medical information associates in preparation and review of medical letters and other medical information materials

· Preparing or reviewing scientific information in response to customer questions or media requests and interactions.

+ Technical Expertise and Employee Development
· Exploring and taking advantage of opportunities for extramural scientific relations.

· Keeping current in relevant scientific literature, limited medical practice (volunteer), and attending scientific symposia.

· Obtaining and maintaining active membership in key professional or specialty organizations.

+ REQUIREMENTS


· Medical Doctor (MD), recognized/established as opinion leader (i.e. NIH, publications, department chair).

· Experience in clinical practice, clinical research or pharmaceutical medicine, and the drug development process relevant to the US

· Excellent communication (written and verbal), interpersonal, organizational and negotiation skills

Candidates must understand that we work in a highly regulated environment and must become familiar with and comply with local and international regulations, laws, guidance (e.g. FDA, ICH, CPMP etc.), Good Clinical Practices (GCP) and Policy and Procedures