VP, Medical Management (Oncology)

Description

Vice President, Medical Affairs

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
  
  

Job Responsibilities

• Operates as a subject matter expert in one or more indications.
• Supports talent identification, hiring, development and management of key medical staff needed to meet the strategic needs of the BU. Manages multiple individuals, frequently supervising multiple levels of staff.
• Serves as the Medical Lead in governance activities at the asset level or portfolio level, characterized by strong peer-to-peer working relationship with senior medical personnel within customer companies and strategic planning and problem-solving skills to deliver clinical studies and programs to customer satisfaction.
• Leads interdivisional (Clinical) and cross-divisional (Clinical, Commercial and Consulting) activities in support of corporate objectives, as assigned, in support of innovative business development opportunities with client companies.
• Provides medical oversight of assigned clinical studies when assigned as a medical monitor. Serves as primary medical contact for customers for assigned clinical studies and as the functional lead for medical colleagues:
• Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department.
• Responsible for protocol design and development, upon request. Provides input into protocol amendments.
• Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed.
• Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts. This activity includes, but is not limited to, review of Informed Consent Templates and Subject-Facing Materials, and input into site feasibility evaluations.
• Provides medical input into data collection tools, monitoring plans, and review and analysis plans.
• Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data. Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data.
• Provides after-hours coverage to clinical studies.
• Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans.
• Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines.
• Leads medical responses to Requests for Proposals (RFPs) and Requests for Information (RFIs) and formulates winning strategies for Bid Defense Meetings (BDMs) as a recognized Thought Leader. Teaches and supervises other medical staff to conduct these activities.
• Contributes to the development of product/clinical development plans, and collaborates with customer and internal colleagues regarding other reports, applications, and regulatory submissions. Locates and engages external experts/consultants/advisors as necessary.
• Represents the Company at scientific and industry meetings. May publish scientific or industry-related articles in industry journals, as requested.
• Participates in BU or cross-functional process improvement initiatives, upon request, and may self-identify initiatives and innovations to advance the mission of the BU.
  

Qualifications

What we’re looking for

• Doctorate degree in medicine and significant clinical experience in the practice of medicine in specific therapeutic area.
• Significant clinical research and demonstrated leadership experience.
• Expert knowledge of drug development process, regulatory policies and procedures.
• Excellent written and verbal communication skills enabling effective interactions with leadership and team members, client company leaders and prospective client company leaders.
• Prior leadership experience required.
• Strong understanding of the use of medical terminology and of drug-names in multiple nations and environments is required.
• Demonstrated ability to lead and excel in a matrix environment.
• High degree of proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.
• Ability to handle multiple priorities to meet deadlines in a dynamic environment is essential.
• Ability to be customer-focused and have a disciplined approach to work is critical.
• Fluency in written and spoken English is essential. T
• ravel up to 25% may be required.
• Must demonstrate effective leadership of other medical or clinical research colleagues and proficiency with data review activities and use of various technologies utilized to display data (e.g., listings, patient profiles, customer databases and systems, and/or data visualization tools).
• Must demonstrate ability to contribute to consulting, commercial, regulatory, and clinical development tasks as a subject matter expert.
  
  

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.