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Senior Medical Director, Psychiatrist

Senior Medical Director, Psychiatrist

Syneos Health groupBuenos Aires, Ciudad Autónoma de Buenos Aires, Argentina
Hace 1 día
Descripción del trabajo

Senior Medical Director, Psychiatrist – Syneos Health

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. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

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

  • Provides medical oversight of assigned clinical studies in the duty as a medical monitor. Often serves as primary medical contact for customers for assigned clinical studies.
  • 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, including 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 for 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 Bid Defense Meetings (BDMs). May support Requests for Information (RFIs).
  • 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.
  • Mentors staff to ensure an appropriate level of understanding regarding sound treatment and research principles of specific therapeutic area. Ensures project teams consistently operate in compliance with such principles.
  • Assumes line management duties as needed.

    • QUALIFICATIONS

  • Doctorate degree in medicine and significant clinical experience in the practice of medicine in specific therapeutic area.
  • Significant clinical research and demonstrated leadership experience.
  • Strong understanding of the use of medical terminology and of drug‑names in multiple nations and environments.
  • Experience working in matrix teams required.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail.
  • Effective organizational and interpersonal skills, communication and language skills, and group presentation skills.
  • Above average attention to detail, accuracy, organizational, interpersonal, and team‑oriented skills.
  • Ability to handle multiple priorities to meet deadlines in a dynamic environment.
  • Customer‑focused and disciplined approach to work.
  • Fluency in written and spoken English.
  • Travel 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, databases and systems, and / or data visualization tools).

    • PHYSICAL REQUIREMENTS

    Position requires ability to occasionally move about inside the office to access filing cabinets, office equipment, and to move between office locations; maintain a stationary position for prolonged periods; occasionally manipulate office items and packages of light to medium weights of 10‑35 pounds; constantly operate a computer and other office productivity equipment; perceive and assess written materials for prolonged periods; and frequently communicate with colleagues on the phone, by email, and in‑person.

    WORK ENVIRONMENT

    This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. The noise level in the work environment is low. This is a largely sedentary role.

    EEO & APPLICABILITY STATEMENTS

    All appointment and employment decisions are made on the basis of merit, and the Company is committed to compliance with the Americans with Disabilities Act. The Company provides reasonable accommodations when appropriate to assist employees or applicants. The Company also adheres to the EU Equality Directive, ensuring inclusive hiring practices.

    SENIORITY LEVEL

    Director

    EMPLOYMENT TYPE

    Full‑time

    JOB FUNCTION

    Health Care Provider

    SUMMARY

    Provides medical oversight of assigned clinical studies. Interacts with senior management, customers, and project teams to ensure subject safety and scientific integrity of clinical studies. Provides therapeutic area medical input and consultation to internal colleagues and customers. Performs the duties of Medical Monitor. Serves as a mentor, consultant, and training guide to Business Unit staff and project colleagues. May be assigned to provide medical oversight to clinical studies or other types of projects such as Medical Monitoring‑only projects or Commercial or Consulting Projects. Is often assigned the role of Functional Lead on assigned clinical studies. Supervises and manages other Medical Directors, as required.

    MARKETING INFORMATION

    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 at

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    Director • Buenos Aires, Ciudad Autónoma de Buenos Aires, Argentina