Senior Medical and Scientific Affairs Director, EMEA

Summary & Scope of Position:

The position will be part of the EMEA INTERCEPT Scientific Affairs Department and will be crucial for directing efforts in support of novel INTERCEPT products and updates of the existing product portfolio and will contribute to the company’s overall success. The position will liaise extensively with external collaborators in support of research and development at Cerus and will also be responsible for publication planning and execution as well as customer presentations in the context of the scientific affairs function. In addition, the position will have direct interactions with regulatory agencies especially, but not exclusively, in French speaking countries to support the extension of label claims and the validity of existing label claims and approvals according to current and future regulatory requirements. The position will work closely with global Medical Affairs team to support the market introduction and drive the post-marketing activities for existing products and new products from the INTERCEPT portfolio including RBC products in EMEA and other markets.

This position will report directly to the Vice President, Global Scientific and Medical Affairs, and in addition will work closely with Regulatory Affairs, Marketing, Sales, Deployment and the Research departments at Cerus.

To accomplish this, a number of key responsibilities are listed:

Primary responsibilities

• Provide Scientific/Medical expertise in various EMEA regions to support the business objectives, in particular, but not exclusively, for the French speaking markets.
• Actively support international sales and marketing teams in different medical disciplines including transfusion medicine, hematology, oncology and others.
• Be the key liaison person for the regulatory department for all interactions needed with the national (esp. French speaking) regulatory agencies.
• Develop and maintain KOL relationships with international thought leaders in all areas of importance to promote existing and future INTERCEPT products.
• Build intensive relationships to professional organizations and patient organizations especially in the area of hematological specialties (hem/onc, SCD, Thalessemia...).
• Initiate collaborations with external investigators to perform in vitro or phase IV studies as required.
• Nourish the relationship to key customers including EFS, RKV and others by the planning and conduct of studies of mutual interest.
• Perform liaison role with Cerus regulatory department and be the link to external regulatory agencies, especially in French-speaking countries.
• Provide input to the International Leadership Team in support of strategic planning and portfolio management processes and progress.
• Participate in annual planning, budgeting, and forecasting for all projects.
• Ensure that progress issues, concerns, and risks are timely and appropriately communicated to the International Leadership Team and project teams.
• Become the Scientific Affairs specialist for the INTERCEPT RBC projects including post-marketing studies to be performed in EMEA.
• Act as a spokesperson at scientific conferences, industry meetings and regulatory hearings, showcasing the company’s innovations and scientific expertise.
• Interact very closely with Scientific Affairs and marketing in the generation of publications and sales tools.
• Collaborate with Regulatory and Legal with regards to overall compliance.
• Perform other related duties as required.

Qualifications / Requirements / Skills

Education and experience

• Minimum master’s degree in Life Sciences, preferentially PhD and or MD.
• Proven track record of preferably a minimum of 10 years in the pharmaceuticals, biotechnology or medical device areas.
• Experience in managing global projects, collaborative partnerships and interactions with regulatory agencies. clinical studies (phase IV)
• Thorough knowledge of pre-clinical and clinical development, regulatory and manufacturing disciplines related to drug/device development.
• Previous experience in corporate strategic planning and portfolio management is a plus.

Capabilities

• Ability to effectively and constructively communicate, coordinate, cooperate and interact with all levels internally (including executive management) and externally.
• Strong leadership and influencing skills in a cross-functional organizational setting.
• Strong analytical mind and global business acumen.
• Position requires both strategic agility and strong attention to detail and execution.
• Excellent communication, organizational and presentation skills with ability to serve as external face of company.
• Proven skills in preparation of publications as result of customer interactions
• Requires on average 50% international travel.

 All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.