Sr. Mgr Medical Development
il y a 1 semaine
Accountabilities
To lead the Affiliate/Sub-Regional TA
To drive the strategy and manage the portfolio for the Affiliate/Sub-Regional TA
Reports (at a minimum) to
- Affiliate/Sub-Regional Medical Director (Direct)
- International TA Head (Indirect)
Responsibilities
- Being the single point of accountability for all Affiliate/Sub-Regional TA activities
- Driving the data generation, establishing and communicating the strategy for the Affiliate Sub-Regional TA
- Developing goals and tactics for the Affiliate/Sub-Regional TA
- Managing resources and budget for the Affiliate/Sub-Regional TA; forecast accuracy within area of responsibility
- Directing Affiliate/Sub-Regional Medical Advisors in navigating products through internal governance and external regulatory portals
- Assisting Affiliate/Sub-Regional Medical Advisors in interactions and communication with external customers, key organizations, and institutions
- Assessing risk and identifying issues, conflicts or gaps (Affiliate/Sub-Regional) across the portfolio
- Hiring, coaching, mentoring and developing staff and team members
- Ensuring Affiliate/Sub-Regional TA goal accountability
- Provide leadership and strategic direction to the Affiliate/Sub-Regional TA staff
- Assist the IML in identifying and resolving clinical/scientific issues
- Perform portfolio level risk assessments and prioritization of programs
- Ensure alignment of earlystage strategy with latestage TA objectives
- Approve Affiliate/Sub-Regional TA plans, goals, proposals and deliverables, including but not limited to protocols and SAP's for local AST's
- Chairs Affiliate/Sub-Regional TA Team meeting
- Foster and improve International collaboration and coordination
- Serve as a key interface to communicate Internationally and Locally important issues and status of programs to Amgen IRD and Affiliate/Sub-Regional Management
- Partner with the Affiliate/Sub-Regional Business Unit for all product lifecycle management activities
- Provide input, review, approve the Affiliate/Sub-Regional lifecycle management plan and ensure alignment across the portfolio
- Provide scientific/clinical oversight for the compilation of regulatory submissions across the portfolio
- Chairs the Local Development Team (LDT)
- Member of the International Development Team (IDT)
- Extended member of the International Business Team (IBT)
- Provide clinical oversight of product safety evaluation within the Affiliate/Sub-Regional TA
- Provide support and leadership for advisory boards
- Set Affiliate/Sub-Regional TA goals and dashboards to evaluate performance
- Ensure adequate resources and budget across all programs (study and nonstudy) and maintain budget accountability
Authority
Direction, activities, and resource allocation within Affiliate/Sub-Regional TA
Integrated portfolio evidence generation and communication plan
Clinical content of Local regulatory agency briefing documents, submissions, and interactions (portfolio level)
Clinical content of Local documents, submissions and interactions with all statutory agencies
Sign-off at signature authority level
Outputs
Affiliate/Sub-Regional TA lifecycle management plans and medical sections of regulatory documents
Affiliate/Sub-Regional TA goals, objectives, and performance metrics
Sr. Management portfolio status reports and dashboards
Sub-Regional TA budget
Minimum Requirements
6 or more years of clinical development experience, 4 years of which should be from a pharmaceutical or biotechnology company
Clinical research experience
Broad and formal leadership experience
Preferred Requirements
In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials
Medical knowledge in the relevant therapeutic area
Sound scientific and clinical judgment
Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups
Knowledge of Good Clinical Practices (GCP), EMEA regulations and guidelines, and applicable international regulatory requirements
Understanding of new drug commercialization and business practices
Understanding of resourcing and budgeting
Proven ability to lead, manage, and motivate others in a complex, multi-functional, multi-national matrix environment
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
Demonstrated ability to organize and lead expert Clinical Research Advisory Panels
History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
-
Sr. Biopharmaceutical Rep
il y a 1 semaine
Diegem, Flandre, Belgique Amgen Temps pleinHOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...
-
Business Development Manager Nl
il y a 1 semaine
Diegem, Flandre, Belgique WEngage Temps pleinDe Business Development Manager prospecteert de markt op een proactieve wijze met als doel nieuwe klanten te werven voor tijdelijke en lange termijn contracten. Hij/zij is verantwoordelijk voor het aanbrengen van nieuwe klanten binnen WEngage.- Sales- Dag- WEngage- Engels, Nederlands en Frans- Telco**Over deze job**:Met WEngage maken we ons klaar voor een...
-
Therapy Development Specialist
il y a 1 semaine
Diegem, Flandre, Belgique Boston Scientific Corporation Temps pleinWork mode:HybridOnsite Location(s):Diegem, BEAdditional Locations: Belgium-DiegemDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and highperforming employees, tackling some of the most important...
-
Brand Activation Manager
il y a 1 semaine
Diegem, Flandre, Belgique Generations Recruitment Temps pleinWhat's in it for you?: An entrepreneurial function with an immediate impact on the company's results. A stimulating and challenging environment working closely with International & ambitious brands. A scaleup culture, with a strong backbone and focus on people & team building. A competitive package and an environment that stimulates and facilitates business...
-
Mgr, Sales Account Mgmt
il y a 1 semaine
Diegem, Flandre, Belgique Carrier Temps pleinDate Posted:Country:BelgiumLocation:De Kleetlaan Diegem, BelgiumJob Title:Sales Manager Belux & Key Account Manager Benelux (M/F)Department: Benelux SalesLocation: Diegem, Belgium / Weert, NetherlandsReports to: Regional directorGoalThis challenging and rewarding position carries two responsibilities. On one side, as Sales Manager Belux you are responsible...
-
Service Delivery Manager
il y a 1 semaine
Diegem, Flandre, Belgique BT Temps pleinService Delivery ManagerJob Req ID:18502Posting Date:21 Jun 2023Function:Business Services & OperationsLocation:Telecomlaan 9, Diegem, BelgiumSalary:CompetitiveLocation: Mons, Belgium_Role and Responsibilities of Service Delivery Manager _ The Service Delivery Manager is an essential and very important part of BT's managed services business. It combines...
-
Microsoft Alliances Senior Program Manager
il y a 1 semaine
Diegem, Flandre, Belgique NTT Temps pleinNTT is a leading global IT solutions and services organisation that brings together people, data and things to create a better and more sustainable future.In today's 'iNTTerconnected' world, connections matter more now than ever. By bringing together talented people, world-class technology partners and emerging innovators, we help our clients solve some of...
-
Talent Community: Field Clinical Specialist, Electrophysiology
il y a 1 semaine
Diegem, Flandre, Belgique Boston Scientific Temps pleinAdditional Locations: Belgium-DiegemDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the...
-
Project Assistant
il y a 1 semaine
Diegem, Flandre, Belgique Page Personnel Temps pleinAdded 05/04/202- Assist the department of this international and joyful company (pharma) Possibility to do parttime 60% up to fulltimeAbout Our Client:Our client is a major global player in the pharmaceutical industry (present is all 5 continents). They develop & bring medical solutions to the world everyday, and their goal is to excel in what they do by...
-
Senior Clinical Research Specialist
il y a 1 semaine
Diegem, Flandre, Belgique Pauwels Consulting Temps pleinJob description: For one of our major clients within life sciences region Diegem, we are looking for a Senior Clinical Research Specialist.As a Senior Clinical Research Specialist, you will be responsible for: Serves as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring...
-
Account Manager-cardiac RHythm Management and
il y a 1 semaine
Diegem, Flandre, Belgique Boston Scientific Corporation Temps pleinAccount Manager-Cardiac Rhythm Management and Electrophysiology:Remote Eligible: Field BasedTerritory: BelgiumAdditional Locations: Belgium-DiegemDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of...
-
Heor & Rwe Manager Benelux (Diegem Based)
il y a 1 semaine
Diegem, Flandre, Belgique Bayer Temps pleinAt Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...
-
Marketing Services Specialist M/w
il y a 1 semaine
Diegem, Flandre, Belgique Zimmer Biomet Temps pleinRequisition Number: EMEA10691Employment Type: Full-timeLocation: DiegemWhat Is It Like To Work at Zimmer Biomet:At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.Zimmer Biomet Offers You An...
-
EMEA Demand Planner
il y a 1 mois
Diegem, Flandre, Belgique Abbott Laboratories Temps pleinAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries. Our...
-
EMEA Demand Planner
il y a 1 semaine
Diegem, Flandre, Belgique Abbott Laboratories Temps pleinAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries. Our...
-
EMEA Demand Planner
il y a 3 semaines
Diegem, Flandre, Belgique Abbott Laboratories Temps pleinAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries. Our...
-
Clinical Study Specialist
il y a 1 semaine
Diegem, Flandre, Belgique ClinChoice Temps pleinAre you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds.ClinChoice, is searching for a Clinical Study Specialist to join one of our partner companies, a large pharmaceutical company leader in the field of...
-
Junior Controller, FP&A
il y a 1 semaine
Diegem, Flandre, Belgique Abbott Temps pleinFor our Vascular division, we are recruiting a Junior Controller EMEA to be based in the EMEA Headquarter in Diegem, Belgium.The Junior Controller, FP&A will work in close collaboration with the Area FP&A Manager and s(he) will be responsible for:Coordinating the timely and high-quality submission of all financial requests in close collaboration with the...
-
Senior Financial Analyst EMEA
il y a 2 jours
Diegem, Flandre, Belgique Abbott Temps pleinFor our Vascular division, we are recruiting a Senior Financial Analyst EMEA to be based in the EMEA Headquarter in Diegem, Belgium.The Senior Financial Analyst will work in close collaboration with the Area FP&A Manager and s(he) will be responsible for:Coordinating the timely and high-quality submission of all financial requests in close collaboration with...
-
Junior Controller, FP&A
il y a 2 semaines
Diegem, Flandre, Belgique Abbott Temps pleinFor our Vascular division, we are recruiting a Junior Controller EMEA to be based in the EMEA Headquarter in Diegem, Belgium.The Junior Controller, FP&A will work in close collaboration with the Area FP&A Manager and s(he) will be responsible for:Coordinating the timely and high-quality submission of all financial requests in close collaboration with the...