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As the Senior Director Medical Affairs, Clinical Nutrition, Pharmacy Tools and IV Fluids you will be responsible for the development and implementation of the medical strategy, and action plan in alignment with the global business segment for Clinical Nutrition, IV Fluids and Pharmacy Solutions. You will act as one of the primary spokespersons for the company with key opinion leaders, at global scientific conferences and advisory boards, and regulatory agencies and accountable to ensure that relevant policies and standards are followed and supported for all aspects of Clinical Nutrition, IV Fluids and Pharmacy Solutions Medical Affairs and work is done with high ethical standards.
Job Responsibility:
Leading and guiding a Global Medical Affairs team and establishing and supporting highly functional working relationships with medical and cross-functional partners
Accountable for medical affairs work required to support Clinical Nutrition, IV Fluids and Pharmacy Solutions including thought leadership for business strategy, innovation/new product development, clinical evidence generation strategy and sustaining product activities to ensure successful product approval, launch, and sustenance
Responsible for representing the company with regulatory and legislative agencies related to Clinical Nutrition, IV Fluids and Pharmacy Solutions
Provide expert opinion/due diligence support on business development opportunities
Develop and manage budgets within scope of responsibility
Provide leadership for and partner with HEOR/RWE for clinical evidence generation strategy, scientific and compliance oversight for Evidence Generation such as Investigator Initiated Research and Real World Evidence activities
Support Global Patient Safety as a product and subject matter expert
Development and implementation of the medical strategy, and action plan in alignment with the global business segment for Clinical Nutrition, IV Fluids and Pharmacy Solutions
Act as one of the primary spokespersons for the company with key opinion leaders, at global scientific conferences and advisory boards, and regulatory agencies and accountable to ensure that relevant policies and standards are followed and supported for all aspects of Clinical Nutrition, IV Fluids and Pharmacy Solutions Medical Affairs and work is done with high ethical standards
Accountable for establishing and maintaining strong collaborative relationships with critical colleagues (such as Clinical Research, HEOR/RWE, Global Patient Safety, and Strategy and Delivery) as well as cross-functional partners (such as R&D, RA, Quality and Marketing) to enable a highly efficient and effective working environment
Global medical support of licensed products, clinical product, device and software development, new product and device approvals, and evaluation of product complaints that may have clinical significance
Participate on division strategic teams including the identification of new indications for existing licensed products
Strategically support Clinical Research throughout the evolution of clinical trial design, execution and completion, providing medical and technical support
Provide medical and technical perspective to the business development function in their efforts to identify potentially promising partnering.
Requirements:
Advanced degree, such as PharmD or PhD required
MD, DO, PA or other clinical specialty considered
Minimum of 10+ years of industry experience, with at least some experience in nutrition ideal
Experience in medical affairs, evidence generation, KOL management, Investigator Initiated Research (IIR) study management, new product development, business development and understanding due diligence
Proven people management/leadership skills with an empathetic style and ability to motivate others
Strong executive presence with excellent leadership, managerial and interpersonal skills and the ability to interact with and influence multiple stakeholders (internal and external) on a variety of levels, to build relationships of credibility and trust with them and to operate effectively in a complex matrix organization
Highly developed business acumen and ability to deal well with ambiguity
Ability to communicate complex scientific/clinical issues in a concise and clear manner
Broad understanding of the regulatory and healthcare environment
Ability to travel 20-25%, including internationally, to attend quarterly meetings, congresses, FDA, etc
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
What we offer:
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave