Director - Medical Affairs, Oncology - Astellas - Northbrook

Job description
Astellas is the bright spot in the pharmaceutical industry -- not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine. We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. Diversity is valued. Individual initiative is rewarded. Astellas offers an environment where our employees can make a real difference. Come, shine with us!Astellas is announcing a Director Medical Affairs, Oncology opportunity in Northbrook, IL.


Purpose & Scope:

The Director Medical Affairs, Oncology in Astellas Scientific and Medical Affairs (ASMA) is accountable for the medical and scientific strategy for one of the products in the Oncology Therapeutic Area. Responsible for ensuring medical strategy and tactics are in place for the particular product Accountabilities include execution of an overall medical strategy for the individual products. Responsible for working closely with key stakeholders across the company to achieve business objectives for the US Region and indirectly for Canada and Latin America, when requested, through support of Medical Affairs colleagues in these countries.

Essential Job Responsibilities:

* Ensures robust US Medical Affairs strategic plans are in place for the assigned compounds in Oncology that are aligned with the Global Medical strategies.
* Potentially leads ASMA-sponsored clinical studies
* Aligns closely with peer colleagues in the US Commercial part of Astellas and participates in cross functional teams;
* Provides US medical affairs input into the global medical strategies of the assigned product.
* Is member of the Publication team; reviews manuscripts and abstracts
* Reviews promotional materials through the MAP Process
* Initiates (and potentially chairs) Advisory Boards in Oncology
* Reviews IIT proposals in Oncology
* Reviews and approves Medical Information letters and slide decks
* Provides medical affairs input in new product licensing and acquisition opportunities for marketed and late-stage compounds that are targeted specifically for the US market when requested.

Quantitative Dimensions:

* Monitors budget and timelines, ensuring effective fiscal utilization per budget.
* Ensures development of strategic plans for post-marketed products and execution of Astellas sponsored post-marketing studies.

Organizational Context:

* Reports to the Executive Director TA Head Oncology, Astellas Scientific and Medical Affairs (ASMA).
* Peer Group: Astellas Product Directors; MSL Therapeutic Area Director; Medical Directors in Global Medical Affairs.
* Interacts with key external experts industry though leaders and collaboration partners.

Qualifications:

Required:
* Minimum 3-5 years clinical experience.
* Minimum 2 years Medical Affairs relevant experience working in the pharmaceutical industry, experience in clinical development is a plus.
* Experience in managing relationships with medical, clinical, regulatory, health outcomes, epidemiology, medical information, and other organizational partners.
* Strong scientific analytical and problem solving skills, strategic capabilities, project management and planning and organizational skills and excellent communication, writing, and presentation skills.
* Strong problem solving in a complex multi track partnership environment.
* Strong leadership and problem solving ability is a must.
* Ability to lead a matrix structured product team across multiple disciplines in support of TA.
* Ability to effectively influence both internal and external stakeholders, customers and partners.
* Demonstrated ability to collaborate and build strategic alignment within the Medical Affairs community and across functions (e.g. with US Commercial).
* Knowledge of regulatory bodies and procedures, as well as anti-kickback laws, which could have impact for the pharmaceutical industry. Appropriate knowledge of guidelines such as IFPMA (International Federation of Pharmaceutical Manufacturers Association) and PhRMA (Pharmaceutical Research and Manufacturers of America
* Fluent in written and verbal business English.

Preferred
* Board Certified in specialty (highly desirable).
* State Licensure to practice medicine (highly desirable).

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