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Director/Associate Director, Study Physician job in Durham at Advanced Clinical

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Director/Associate Director, Study Physician at Advanced Clinical

Director/Associate Director, Study Physician

Advanced Clinical Durham, NC Full-Time
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team in North Carolina as a Director, Study Physician. This remote role will collaborate with various project teams to design, plan, and execute trials and a clinical development program. If you are a career-focused professional, this is the role for you.

RESPONSIBILITIES
  • Lead clinical study design and collaborate internally to construct high-quality clinical study protocols
  • Engage and introduce new compounds in development to external scientific leaders/KOLs and seek feedback for clinical development plan and protocols
  • Plan/execute site assessment, site selection, and train investigators/staff
  • Perform clinical monitor for studies and work with study team to ensure safety, efficacy, quality, accurate data captured, and serious adverse events reviewed
  • Serve as the contact for site study team to address protocol-related questions and any emerging safety issues
  • Provide input and approve monitoring plan, reports, and data listings
  • Interpret, contribute to clinical study reports, and lead clinical/safety components of regulatory interactions
  • Prepare and review manuscripts, abstracts for publication, and data presentations
  • Participate in due diligence evaluation of relevant opportunities

EXPERIENCE
  • Minimum of 5 years of experience in biotechnology or pharmaceutical industry required
  • Knowledge, experience, and skill with a proven track record of accomplishment in the field of clinical development
  • IND filing experience desired
  • Experience in CNS/neurology preferred
  • Experience in Phase 2 and Phase 3 multicenter studies of CNS disorders, including mood disorders (MDD), in US and global setting
  • Demonstrated experience with protocol and study report writing desired
  • Detailed understanding of cross-functional processes involved in study design and execution (protocol development, data management, safety/ pharmacovigilance, biostatistics, medical writing, quality assurance, regulatory, and medical affairs)
  • Experience and ability to maintain a professional relationship with therapeutic area opinion leaders to discuss the science and research approaches that are critical for study protocol design and data interpretation
  • Detailed knowledge of Good Clinical Practices and International Conference on Harmonization Guidelines required
  • Excellent attention to details in a time sensitive environment
  • Strong problem-solving, interpersonal skills, and communication skills required
  • Good leadership skills to effectively influences actions/opinions of others and treat people with respect

EDUCATION
  • Minimum of Medical Degree (MD) required
  • Clinical training in psychiatry, neurology, or internal medicine desired

To be a best-fit your strengths must include:

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
  • Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
  • Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality and Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent and Client, visit [ Link removed ] - Click here to apply to Director/Associate Director, Study Physician

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

Recommended Skills

  • Analytical
  • Attention To Detail
  • Biopharmaceuticals
  • Biostatistics
  • Biotechnology
  • Clinical Study Design
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