Bayer Global Clinical Leader MD in Residence Based, Massachusetts
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Global Clinical Leader MD
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Global Clinical Leader, Women’s Healthcare, are to:
Lead the Global Clinical Development Team (GCT), a cross functional, multinational team of internal experts, through clinical phase II – III trials, global product registration, and international and/or multicenter trials supporting product life cycle optimization/label extension;
Set project-related objectives with GCT members and provide input to their annual performance evaluation (PMP completed by the functional line manager). Request Development team members to participate in GCT and clarify resource availability with global functional heads;
Be a member of the Global Project Team (a cross functional, interdisciplinary team of internal participants driving product development as a whole) representing Development;
In consultation with relevant key disciplines, prepare the Clinical Development Plan (CDP), including an operational plan with high level resource planning (timelines, budget and manpower);
Be responsible for planning and managing the clinical timelines, managing clinical budget (external clinical grants and Clinical Research Organization (CRO) management fees) and manpower against the approved CDP and approved resources. Proactively initiate corrective action as needed;
Be responsible for the ongoing risk-benefit assessment of a compound until approval in a main country;
Analyze incoming clinical data, relevant medical and scientific information and initiate actions or decisions as appropriate;
In consultation with the Head of the Therapeutic Area (TA) and Global Project Leader (GPL), communicate medical aspects of project strategy and study strategy, study results and clinical project results to internal and external bodies (e.g. Global Product Development Committee, regulatory authorities);
Prepare assessments and recommendations at Decision Points, and present them together with the GPL to the Global Product Development Committee;
Be responsible for defining the strategic approach and managing preparation of clinical sections of key Regulatory documents (Integrated Summary Efficacy (ISE), Integrated Summary of Safety (ISS), Clinical Overview). Consult with internal expert functions during development of these documents;
Compile and maintain Investigators’ Brochures (IB);
Provide clinical expertise to Global Strategic Marketing (for marketed products) and Strategic New Product Marketing (for development projects) and define together with Global Medical Affairs the publication strategy;
Approve publications and ensure consistency of publications with clinical data and publication strategy;
Along with Global Medical Affairs, contribute to Opinion Leader development and publication strategy with implementation detail;
In conjunction with Global Medical Affairs, establish and maintain appropriate external scientific advisory boards and assist in advocacy development;
Provide clinical assessment of in-and out-licensing opportunities of development project;
Review/approve domestic study concepts to ensure compliance with global development strategy;
Allocate studies to countries together with the global heads of Clinical Portfolio and Operations.
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
Highly successful M.D. with extensive professional and academic experience;
Proven leadership, motivational and interpersonal skills;
In-depth understanding of the drug development and commercialization process with a base of experience of five plus (5)+ years in Medical Science and drug development (from protocol writing to Medical Readiness Review (MRR) or extensive background in participation in clinical research;
Must provide clear vision, direction, and purpose in the different cultures present within the Development TA’s and the Global Bayer organization;
Must embrace change and be able to work in a changing environment;
Strong communication skills to ensure that project plans and status are transparent, and that risks, issues, and results are clear to all involved parties;
A matrix structure requires additional skills in gathering information, arriving at decisions, negotiation and communicating decisions and action;
Must execute his/her responsibilities with knowledge, accuracy, persistence, resilience and creativity seeking to work both independently and collaboratively.
Board certification in a relevant therapeutic area.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Location: United States : Connecticut : Residence Based || United States : Delaware : Residence Based || United States : District of Columbia : Residence Based || United States : Florida : Residence Based || United States : Georgia : Residence Based || United States : Indiana : Residence Based || United States : Kentucky : Residence Based || United States : Maine : Residence Based || United States : Maryland : Residence Based || United States : Massachusetts : Residence Based || United States : Michigan : Residence Based || United States : New Jersey : Residence Based || United States : New York : Residence Based || United States : North Carolina : Residence Based || United States : Ohio : Residence Based || United States : Pennsylvania : Residence Based || United States : Rhode Island : Residence Based || United States : South Carolina : Residence Based || United States : Tennessee : Residence Based || United States : Vermont : Residence Based || United States : Virginia : Residence Based || United States : West Virginia : Residence Based
Reference Code: 270126
- Bayer Jobs