Medical Director Job - Regenerative medicine

Our client is a leading regenerative medicine company, pioneering living cell-based therapies for skin regeneration and wound care. Their advanced technologies offer a revolutionary approach to medicine, delivering living products to stimulate the body's own natural healing process. They are a market leader in their field with a strong line of marketed products with a supporting sales team as well as a robust pipeline of new therapies in clinical trials.





The Medical Director is the Company’s internal expert providing clinical and scientific information on wound healing and connective tissue repair and its licensed products in those therapeutic areas. Provides in depth medical & scientific support (verbal and written) to Company’s internal (Medical Affairs, Clinical Operations, Regulatory Affairs, Marketing, Sales, R&D, Business Development, Health Policy and Investor Relations) and external customers.



Reporting to the Chief Medical Officer within the Medical Affairs Division works cross-functionally to strategically guide the development of products in development and potential new indications for approved products. The candidate must have good interpersonal skills and the ability to work in a cross functional matrixed organization.

Key Responsibilities



Provide Expert Knowledge to External Customers:



* Develop high level national & international network of KOL relationships in wound healing.

* Leverage this network as required for advisory boards, guideline development, publication planning, speaker’s bureau and clinical trial site identification.

* Interact with potential investigators and perform medical reviews of Investigator Initiated Study proposals.

* Work with Wound Care Centers to influence and guide the development of appropriate treatment protocols.

* Represent Company by presenting at national & international conferences and projects. with external organizations

* Develop/support relationships with key organizations and advocacy groups



Support Medical Affairs Activities:



* Provide clinical, scientific & functional support & guidance to MSLs as required.

* Provide medical and scientific input to and advice on publication planning in wound healing.

* Review & approval of non-promotional materials (e.g. manuscripts) from clinical perspective.

* Develop & review summaries of literature and information relating to Company licensed products and competitor products in the field of wound healing and regeneration.

* Upon request, provide medical and scientific support to Medical Information Contact Center.



Provide Medical Expertise to Clinical Operations:



* Provide guidance to the clinical operations team on protocol development for new or existing products (indications, endpoints, inclusion criteria, investigator selection etc.).

* Provide medical input to post-market study design (e.g. registries, retrospective studies, and safety surveillance).

* Perform as Medical Monitor on select clinical trials.



Commercial:



* Assist in Sales training regarding the science of wound healing & regeneration, clinical management of wounds, Company technology & products, and competitor products relating to this therapeutic area.

* Contribute to the development and implementation of Company’s long and short-term business strategies to optimize markets for future and current products in wound healing and development of rational strategic plans for profiling and indication expansion of licensed products.

* Provide medical perspective to marketing team regarding optimal product positioning & physician education.

* Serve as an expert medical resource to commercial partners on their tactical projects.

* Provide medical perspective on potential new business development opportunities as required.

* Provide medical support to Health Policy initiatives (e.g. Reimbursement).



Regulatory:



* Medical Affairs representative & signatory for Advertising & Promotional review of promotional materials for licensed products to ensure evidence-based approaches, medical accuracy and fair-balance.

* Provide medical and scientific direction on clinical matters affecting the preparation and submission of timely and sound information to the regulatory authorities.

* Evaluate and provide reports on adverse events as required; determine if corrective actions are necessary.

* Conduct quarterly safety update on all Company products and share information with internal stakeholders.



R&D:



* Provide clinical input on preclinical study design and analysis and new product development.

* Help narrow potential clinical field of use and define the Target Product Profile for specific indications for potential products and products in development.

* Support Design Control activities for products in development.

* Medical support for FMEA

* General: Maintain knowledge base as to developments and trends in medical sciences. This is expected to include attendance and participation at key conferences on skin & connective tissue regeneration and cutaneous wound healing. Contribute to the training, leadership and continuing education for all departmental staff.



Job Requirements



* MD with specific training and/or experience in wound healing and/or regenerative medicine (e.g. plastic & reconstructive surgery, orthopedic surgery, and dermatology). Clinical and research experience is highly desirable.

* Must have working knowledge of all areas of product lifecycle management, from pre-clinical development through post-approval marketing.

* Minimum of 2 years serving as a medical professional in a medical device, biotechnology or pharmaceutical company.

* Specific Medical Affairs experience is highly desirable.

* Education in the areas of experimental design, statistics, technical writing, product development, and management is desirable.

* Knowledge of Good clinical Practices and regulations relative to the conduct of clinical trials.

* Experience working with federal regulatory agencies is a plus.

* Track-record of success working cross-functionally; solution & action oriented.

* Excellent written and verbal communication skills, as evidenced by a record of publications, medical writing and or public speaking.

* Able to provide education on complex scientific/medical issues in a crisp and clear manner both to a peer and lay audience.

* Travel up to 30-40% (approximately 2/3 domestic and 1/3 international).



About ESG



Founded in 1998, The Executive Search Group is a highly specialized search and recruitment firm, with practices in the Banking and Life Sciences industries. Through twelve-years of commitment, performance, and success, ESG has developed a reputation for bringing together our highly reputable client base with the most exceptional professionals within their respective industries.



To do this consistently takes experience in the markets we serve, and an understanding of our clients’ needs and our candidates’ aspirations. Each member of our dedicated team is an industry expert, highly trained in needs-analysis, search, and recruitment.



To APPLY go to: http://www.researchgate.net/job/11555_Medical_Director_Job-Regenerative_medicine