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Medical Director and Healthcare Compliance (HCC) Lead, Poland and Baltics

Req #: 1801099
Location: 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: Regular
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.

Summary

  • 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

Leadership Characteristics

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.

Communicating effectively

Writes and presents effectively; adjusts to fit the audience and the message; strongly gets a message across.

Relating Skills

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.

Inspiring Others

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.

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