PPD’s mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.
Due to continued growth, PPD is now looking to appoint an Medical Director, Haematology, to join our client-dedicated team of Medical Directors in EMEA/NA. This role can be office-based or home based.
This position provides strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process. This person is responsible for the design, development and execution of Clinical Development Plans (CDPs), clinical trials and protocols in accordance with applicable GCP regulations. This person leads and contributes to the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical/regulatory objectives and the documentation of study results.
This person may act as a clinical/medical representative in meetings with external stakeholders (e.g. collaborators, Key Opinion Leaders (KOLs), investigators, regulatory authorities, etc.), partners (e.g. vendors, consultants, etc.) and other external audiences as needed.
- Provides medical content and leadership of the clinical studies
- Medical Monitoring of clinical studies
- Establish and approve scientific methods underlying the design and implementation of clinical protocols
- Ensure study subject safety
- Regularly review adverse event, laboratory and other clinical data, ensure reporting is done on a timely basis
- Collaborate with the study executive and independent safety committee when needed
- Represent clinical research through membership on trial teams.
- Contributes to, reviews and approves study protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs) and other clinical documents as required for the conduct of clinical trials
- Interprets, summarizes and documents clinical data for regulatory documents (e.g. INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required.
- Collaborate with leading academic medical centres
- Recruit, guide and motivate clinical investigators
- Ensure study compliance by understanding and applying all relevant SOPs and GCPs
- Participate in long range strategic planning
Education & Qualifications
- MD degree, a minimum of 5 years of clinical drug development experience
- Drug Development experience in the area of Haematology
- Desirable: Experience in the therapy areas of (Monoclonal Antibodies) and/or Translational Medicine.
Skills and Competencies:
- Demonstration and commitment to vigilant proactive problem solving
- Excellent leadership abilities
- Able to provide multiple examples of creating and implementing the scientific and clinical principles used for the preparation of clinical studies and clinical trial protocols.
- Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data.
- Previous experience with regulatory submissions.
- Excellent written and verbal communication skills.
- Ability to travel.
At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
- Srbija, Beograd, Ljubostinjska 2 11000 Beograd
- PIB: 107062915
- Matični broj: 20735023