Job Title: Clinical Research Director
Location: Cambridge, MA
About the JobThe
Clinical Research Director (CRD) is
a key clinical lead in the Development of R&D programs. The role requires a well-organized, strategically, operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills, and the ability deliver to multiple operational tasks.
The role of the CRD is to:
- Collaborate with other medical and clinical scientific experts DMDs or Development Scientific Directors (DSDs) in the project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction
- Provide clinical scientific expertise in the Study team to conduct the clinical studies from early phases to LCM programs
- Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc...)
- Provide appropriate clinical scientific input & support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
- Contribute to the clinical part of Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA etc...) and answer to questions from health authorities.
- Be the scientific & medical reference in the Study team, ensuring the medical relevance of the clinical data
- Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc...)
Key responsibilities include: 1. Leading the clinical development plan strategies:- Responsible for the clinical development plans and clinical sections of integrated development plans (IDP)
- Collaborate with other DMDs/DSDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related issues, anticipates potential issues (sharing lessons learned) across the project or study teams
- Raise study or project-level issues to the project head and propose related corrective action plans
- Contribute in the definition of the product value proposition (TVP), Target Product Profile (TPP) and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research project
- Collaborates with external partners, regulators, scientific experts and internal stakeholders
- Raise study or project-level issues to the project head and propose related corrective action plans
- Evaluates relevant medical literature and status from competitive products
2. Lead, Support and oversee the execution of clinical development and studies activities- Collaborate and communicate appropriately with all function stakeholders (e.g. clinical operations, project management, Patient Safety and Pharmacovigilance, regulatory, Finance, Scientific External Engagement, Procurement etc...), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)
- Develop the abbreviated protocol, the final protocol and protocol amendments
- Develop/review the Core Study Informed Consent Form (CSICF)
- Develop/review Study committee Charters
- Collaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret feasibility and competitive intelligence results
- Review and provide clinical input across different study documents Vendors RFPs, (e-)CRF,( e-)diary, (e- )CoA etc
- Raise study or project-level issues to the project head and propose related corrective action plans
- Participate in the elaboration of training material and presentations at the investigator meetings/local teams trainings
- Answer to medical questions raised by HA, EC/IRBs, sites
- Ensure quality of clinical data through continuous data validation, blinded Data review on summary tables or electronic data visualization during clinical trial conduct (AE dedicated review, and Clinical Case review for safety data and statistical surveillance for efficacy data,...)
- Raise study or project-level issues to the project head and propose related corrective action plans
- Lead the study specific committees (IDMC, steering com, adjudication ...) with operational support
- Co-Develop the SAP in collaboration with bio stats
- Responsible for key results preparation
- Raise study or project-level issues to the project head and propose related corrective action plans
Responsibilities related to regulatory and safety documents and meetings:- Review and/or contribute in the clinical section of the Investigator's brochure, CTA, IND, DSUR, , DRMP, RMP
- Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP
- Ensures clinical data meets all necessary regulatory standards
- Collaborates with the Patient Safety GSO to detect and document any safety signal
- Participates in Advisory Committee preparation
Scientific Data evaluation and authorship:- Participate and author manuscripts and abstracts
- Establish and maintains appropriate collaborations with knowledge experts or advisory boards
- Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for the therapeutic area and serves as the clinical advisor to research teams
Experience:- Understanding of pharmaceutical product development and life cycle management
- Very good Scientific and medical/clinical expertise
- Very good expertise in clinical development and methodology of clinical studies
- Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
- Excellent problem solving capability
- Demonstrated capability to challenge decision and status quo with a risk-management approach
- Ability to negotiate to ensure operational resources are available for continued clinical conduct
- Fluency in written and spoken English
- Very good teaching skills, demonstrated ability to assist and train others
- Ability to work within a matrix model
- International/ intercultural working skills
- Open-minded to apply new digital solutions
About YouMinimum Level of any Required Qualifications: - Medical degree (MD) with specialization in dermatology or allergology or GP with experience in dermatology development
- Minimum 3 years in Clinical or Pharmaceutical industry experience (Atopic Dermatitis or Hidradenitis suppurative preferred)
- Previous experience in clinical development
The salary range for this position is:
$206,250.00 - $343,750.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
