Job title: Senior Clinical Research Director
Clinical Research Director (Sr CRD) is the primary clinical lead for programs.
The role requires a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.
The role of the Senior CRD is to:
- Act as a mentor for other CRDs and Clinical Scientists on within the project/Therapeutic Area (TA).
- Collaborate with functions to ensure uniform, aligned operational approach (e.g harmonizing study documents, ES, protocols, etc). As relevant, within a project, ensure leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to TA Heads, as relevant and shares relevant information within and beyond Project teams.
Take on as necessary the CRD role:
- Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report).
- Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment).
- Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities.
- Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators.
- Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data.
- Interact with other CRDs in the project, Global Project Head, Pharmacovigilance, Regulatory and other key functional reps.
Main responsibilities:Lead the clinical development plan strategies:
- Prepare documents and presentations for internal governance meetings.
- Responsible for the clinical development plans and clinical sections of integrated development plans (IDP).
- Collaborate with other CRDs within the project, providing leadership and building consensus.
- Coordinate action plans with stakeholders to resolve project-related study issues, anticipating potential issues (sharing lessons learned) across the project or study teams
- Raise study or project-level issues to the project head.
- Contribute to the definition of the product value proposition (TVP), 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 projects.
- Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators.
- Evaluates relevant medical literature and status from competitive products.
Lead, support and oversee the execution of clinical development and studies activities:
- Review and validate the clinical study report.
- Develop the abbreviated protocol.
- Review and validate the final protocol and protocol amendments.
- Review the ICF WSI and TDF.
- Co-Develop the SAP in collaboration with bio stats.
- Responsible for key results preparation.
- Develop the clinical study report.
- Assisted by related functions (e.g. clinical operations, project management, and procurement), 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).
- Medical support to clinical operation team during the clinical feasibility.
- Review and provide clinical input across different study documents CRF, e-diary, monitoring plan.
- Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, ...) with clinical scientist, bio stat and GSO.
- Lead the study specific committees (IDMC, steering com, adjudication ...) with operational support.
- Answer to medical questions raised by EC/IRBs, sites.
Responsibilities related to regulatory and safety documents and meetings:
- Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and projects.
- Lead the strategy and structure of the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP.
- Supports registrations, label submissions and modifications.
- Review and/or contribute in the the clinical section of the Investigator's brochure, CTA, IND, DSUR, INDAR, DRMP, RMP.
- Contribute to the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP.
- Ensures clinical data meets all necessary regulatory standards.
- Participates in Advisory Committee preparation.
Scientific Data evaluation and authorship:
- Participate and author manuscripts and abstracts.
- Support the planning of advisory board meetings.
- Establish and maintains appropriate collaborations with knowledge experts.
- Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams.
About YouMinimum Level of Required Qualifications:
- Medical Doctor (MD) or equivalent
- At least 5 years experience in clinical development within the pharmaceutical industry or CRO
Preferred Qualifications:
- MD/PhD
- Specialty in Hematology
- Strong scientific and clinical acumen
- Expertise in clinical development, the methodology of clinical studies and life cycle management
- Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies.
- 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
- Excellent 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
The salary range for this position is:
$236,250.00 - $393,750.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
