Other Locations:Poland- Warszawa
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
- Member of the Polish affiliate Management Committee.
- Drives and manages all Medical Department activities: Regulatory Affairs, Clinical Research, Medical Affairs, Drug Safety, Compliance and Medical Information.
- Provides reports with effective guidance and clear directions with respect to GCP, local and International SOPs as well as Polish regulatory compliance.
- Is in charge of the Scientific Service and as such responsible for Company compliance with all the rules regulating the appropriate conduct of scientific information activities and medicinal products’ advertising.
- Gives support to other functions (Market Access and Commercial).
- Supports the integration of the I&I franchise in Poland and Baltics from a medical perspective.
Role and Responsibilities
- Provision of strong leadership to Medical Department, including ensuring recruitment, coaching and people as well as organizational development.
- Fosters a leadership culture, which attracts, develops and retains high caliber candidates, helping to build and shape a scientific talent pool that will drive the future success of Celgene locally and internationally.
- Development of a strong medical leadership team incorporating regulatory & medical affairs (including medical information), clinical operations and drug safety & risk management.
- Establishes a culture of organizational performance and delivery by focusing on high priority, core activities and behaviors within a rapidly growing organization. Ensures that the Medical Department Goals, Objectives, Performance metrics are met.
- Establishes the presence and reputation of Celgene thought leadership.
- Implements the strategy for the growth and development of the medical function. Supports a strong virtual team across the European region.
- Establishes a compelling vision for the medical and clinical organization in Poland & Baltics in accordance with the international strategy that drive scientific product development and medical information activities to the highest standards and optimal organizational outcome.
- Further develops and enhances Celgene’s leadership presence in hematology and oncology.
- Strategic design, development and execution of Medical Affairs activities.
- Actively supports commercial colleagues to underline the scientific and medical value of Celgene’s products.
- Driving and supervision of KOL management, professional societies and other key customers in Poland & Baltics and acts as the executive corporate medical representative.
- Strategic development and oversight of the execution of IIT plans through Medical Affairs Manager.
- Establishing a professional and inspiring relationship with the overall organization and functions ensuring a positive contribution to the objectives of the organization. This includes co-ordination with the hematology and oncology commercial team seeking for synergies and optimally servicing joint and overlapping customer audience.
- In collaboration with commercial dept develops privileged relationships with key opinion leaders in order to foster a reliable and scientifically completes approach to the fundamental issues affecting the industry.
- Ensures training and scientific compliance by leading and/or supporting all functions in charge of implementing the management of the system of scientific information.
- Ensures strong hematology/oncology specific knowledge consistent with priorities at local and regional level. Serves as the in-house expert for respective hematology/oncology indications and drugs in development for those indications.
- Develops new and innovative strategies in close collaboration with other Medical Directors in Europe and the US related to regulatory and clinical use of new and existing pharmaceuticals.
- Oversights the Investigator Initiated study process in the country and region.
- Ensures the local execution of European/Global strategies of Clinical Development Operations programs via close interface with CROs through Celgene’s Clinical Team and the Clinical Research Manager.
- Supports planning, designing, development, oversight and management of Phase I through IV clinical programs within the country and region, primarily but not exclusively in hematology/oncology (according to Corporate and EU Region strategies).
- Supervision of adherence to all safety reporting requirements according to respective local and international requirements through Drug Safety Manager.
- Guarantees the conduct of medical and scientific activities according to all relevant regulations including responsibility for sign-off of appropriate documents (e.g. Country SOP, contracts, etc.). INFARMA code compliance. Pro-actively integrates medical and scientific insight into local, regional and global strategies, plans and tactics.
- Drives relations with GCPpl and other relevant stakeholders.
- Influences Celgene’s future growth by participating in reviews on the potential of licensing compounds.
- Develops and sustains excellent professional relationships with regulatory authorities, investigators, scientific societies, cooperative groups, clinical research organizations, as well as internal customers, including pre-clinical development, regulatory affairs, drug safety, manufacturing/product development, sales and marketing.
- Interfaces effectively with the global science and marketing organizations to maximize lifecycle opportunities for products both locally and at a global level. Seeks out and leverages opportunities for sharing of knowledge and activities on a global basis;
- Reviews and provides input to potential in licensing compounds
Skills and Knowledge Requirements
The ideal candidate will not only bring a significant pedigree in medical marketing, but will likely also bring experience of clinical development, KOL engagement and relationship-building. Just as important as the ‘technical’ background, the new Medical Director should demonstrate a real focus on (and passion for) leadership and people development.
Therapeutic experience in Oncology/Hematology is a distinct advantage, but this is not to be sought at the expense of the broader business and leadership/soft skills.
Personal characteristics will be absolutely crucial, as the successful individual needs to have the self-sufficiency, energy and drive to take this opportunity and run with it, with exceptional communication and leadership skills, as well as a level of comfort at working in a high-growth, fast-paced matrix environment, where influencing and negotiating across an organization are a prerequisite.
Specifically, he/she shall possess the following:
- MD, with further qualifications (i.e. MBA, PhD, Specialist) advantageous
- Strong clinical research and medical affairs experience in the biopharmaceutical industry.
- Therapeutic experience in the oncology/hematology area highly advantageous.
- Experience of IIT management.
- New product development/clinical development experience desirable including the ability to shape clinical trial design with a strategic mindset.
- Sound knowledge of the Polish pharmaceuticals industry environment as well as the legal/ healthcare system.
- A solid understanding of the pharmaceutical product development process and a strong awareness of the interface between R&D and marketing.
- Experience leading and/or working closely with Drug Safety, Regulatory Affairs, Medical Affairs and Clinical Development teams.
- Budgeting experience, resource management experience.
- Excellent network of customer contacts and strong customer orientation; science-based and marketing-minded.
- Strong people management skills, including proven track record of successful leadership of cross-functional teams.
- Ability to contribute effectively to the Polish Management Committee working cross-functionally to achieve organizational goals.
- Intellectually nimble with strong business acumen, analytical skills and results orientation and emotional intelligence toward internal and external stakeholders.
- Ability to manage change and proven record of showing adaptability in leadership and line management.
- Excellent communication, influencing and presentation skills, scientific and non-scientific, throughout all levels and geographies of an organization.
- Strong identification with Celgene’s values.
- A person who is confident with ideas and innovative thinking and is able to tailor them to productive ends with the courage of his/her convictions
Making Complex Decisions
Can solve even the toughest and most complex of problems; great at gleaning meaning from whatever data is available; is a quick study of the new and different; adds personal wisdom and experience to come to the best conclusion and solution, given the situation; uses multiple problem-solving tools and techniques.
Creating the New and Different
Is able to come up with the next great breakthrough thing to do; is creative, a visionary, and can manage innovation; is an effective strategist full of ideas and possibilities; sees multiple futures; has broad interests and knowledge; can both create and bring exciting ideas to market; comfortable speculating about alternative futures without all of the data.
Getting Work Done Through Others
Manages people well; gets the most and best out of the people he/she has; sets and communicates guiding goals; measures accomplishments, holds people accountable, and gives useful feedback; delegates and develops; keeps people informed; provides coaching for today and for the future.
Being organizationally savvy
Maneuvers well to get things done; “maze bright” and operates smoothly across boundaries; knows where to go to get what he/she needs; politically aware and agile; knows what the right thing to do is; presents views and arguments well.
Writes and presents effectively; adjusts to fit the audience and the message; strongly gets a message across.
Warm, friendly, and interpersonally agile; easy to approach and talk to; relates well to all kinds of people; makes a pleasant first impression and builds solid relationships.
Is skilled at getting individuals, teams, and an entire organization to perform at a higher level and to embrace change; negotiates skillfully to achieve a fair outcome or promote a common cause; communicates a compelling vision and is committed to what needs to be done; inspires others; builds motivated, high performing teams; understands what motivates different people.