Proclinical is currently recruiting for a Clinical Scientist with a leading biotechnology company located in Boston, MA. Successful candidate will support and coordinate specific clinical development activities related to assigned study or program and provide clinical development expertise and input at various cross-functional teams supporting the development of assigned study or program.
- Ensure adherence to pertinent regulatory requirements (e.g., GCP) and to departmental policies, practices and procedures.
- Ensure all work performed on assigned study(ies) or program(s) meets all GCP/ICH Guidelines and is Inspection Ready.
- Routinely review study data on an ongoing basis on all assigned study(ies) to ensure consistency and validity from a clinical perspective.
- Take the lead in drafting all protocol synopses, protocols, protocol amendments, and clinical study reports (Senior Clinical Scientist, Senior Clinical Scientist-Clinical Lead).
- Review and provide clinical development input on relevant sections of all other key study documents [e.g., informed consent form (ICF), Case Report Forms (CRF), Laboratory and Pharmacy Manuals, Investigator's Brochure (IB), Development Safety Update Report (DSUR), Investigational New Drug (IND) application/Clinical Trial Application (CTA) ].
- Review and provide input on the design of CRFs from a clinical perspective; participate in user acceptance testing to ensure the appropriate support of data collection.
- Provide leadership and guide decision making within the Clinical Study Team (Senior Clinical Scientist-Clinical Lead).
- Provide expert and collegiate support to other members of the drug development team to ensure full success of the company's portfolio and regulatory milestones.
Skills and Requirements:
- PhD, Pharm D, MS or BS in a related scientific subject (Senior Clinical Scientist-Clinical Lead)
- Experience in oncology drug development (required for Senior Clinical Scientist-Clinical Lead)
- 3+ years of pharmaceutical industry experience (Clinical Scientist)
- 5+ years of pharmaceutical industry experience (Senior Clinical Scientist)
- 8+ years of pharmaceutical industry experience with at least 3 years of clinical development experience (Senior Clinical Scientist-Clinical Lead).
- Thorough understanding of the drug development process including experience with contributing to the development of key clinical documents (e.g., protocols, ICF, IB, DSUR, CRF) and ability to review clinical data for consistency and coherence.
- Must demonstrate clear understanding of how to safeguard patient safety during the conduct of clinical studies.
- Ability to work effectively in cross-functional teams.
- Self-motivated; demonstrated success in delivering assigned tasks according to timelines.
- Ability to think outside the box and problem-solve.
- Ability and willingness to represent clinical development voice at cross-functional team meetings (Senior Clinical Scientist-Clinical Lead).
- Ability to integrate complex clinical and translational data (Senior Clinical Scientist-Clinical Lead).
- Demonstrated ability to lead clinical teams (Senior Clinical Scientist-Clinical Lead).
- Ability to listen to and integrate input from cross-functional team and then make clear decisions (Senior Clinical Scientist-Clinical Lead).
- Experience leading interactions with global health authorities in support of IND/First in Human stage programs (Senior Clinical Scientist-Clinical Lead).
- Strong interpersonal skills with the ability to drive and influence decision-making (Senior Clinical Scientist, Senior Clinical Scientist-Clinical Lead).
- Professional exposure to multiple functions within biopharmaceutical drug development (Senior Clinical Scientist-Clinical Lead).
- Ability to work closely and collaboratively with senior leaders from across the company (Senior Clinical Scientist-Clinical Lead).
- Deep understanding of, and experience with, developing immunotherapy in oncology.
- Experience working with CROs including providing oversight.
- Previous experience managing direct reports (Senior Clinical Scientist-Clinical Lead).
- Experience leading interactions with global health authorities in support of BLA/labelling (Senior Clinical Scientist-Clinical Lead).
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Miles Tobin at (+1) 617-545-5922 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.