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Medical Director & Health Care Compliance (HCC) Lead, Poland & Baltics

Req #: 1800078
Location: Warszawa, Warszawa PL
Job Category: Medical
Work Location: Celgene sp. z o.o., ul. Królowej Marysieńki 74 CELPOLAND 02954
Organization: Celgene Poland
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Fixed Term
Job Level:
Travel:
Other Locations:Poland- Warszawa

Description

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.

Role and Responsibilities:

  • Provision of strong leadership to medical department, including ensuring recruitment, coaching and people as well as organisational 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 organisational performance and delivery by focusing on high priority, core activities and behaviors within a rapidly growing organisation. 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 organisation 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 haematology 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 organisation and functions ensuring a positive contribution to the objectives of the organisation. This includes co-ordination with the haematology and oncology commercial team seeking for synergies and optimally servicing joint and overlapping customer audience.
  • In collaboration with commercial department 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 haematology/oncology specific knowledge consistent with priorities at local and regional level. Serves as the in-house expert for respective haematology/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 maximise life-cycle 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 medical director should demonstrate a real focus on (and passion for) leadership and people development.

Therapeutic experience in oncology/haematology 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/haematology 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 pharmaceutical 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 organisational 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 organisation.
  • Strong identification with Celgene 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.

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