Head - Clinical Development

The role reports to the Head of Clinical Development and works closely with clinical research operations, clinical development functions and medical affairs. This is a visible role in the organization and will manage key internal and external stakeholders.

The overall scope of the role is to help plan, execute, maintain oversight and report on clinical trials, from planning, vendor selection (if applicable) and site feasibility, through study close out; also provide direction to ensure all trial outputs from protocol development to final clinical study report (including archiving of the Trial Master File) are delivered on time, within budget, and with high quality, in adherence to internal SOPs, GCP and applicable regulatory guidelines. Assists the Head of Clinical Development in protocol design, development, management of clinical advisory boards, liaising with investigators on scientific matters.

Key Responsibilities and Duties:

- Provide clinical operations related input to the Clinical Development Plan

- Ensure that the design of clinical studies under area of responsibility is in line with the objectives defined in the Clinical Development Plan or other relevant plan such as Risk Management Plan

- Contribute to develop or coordinate development and approval of study documentation such as the study protocol, ICF, study-specific guidelines, regulatory documents, monitoring, data management and statistical analysis plans and clinical study report, in accordance with internal SOPs and GCP requirements

- Work towards study timelines and milestones

- Assess needs for External Service Providers (ESPs), identify and select ESPs, including negotiation of scope of work and budget and ensure that related contracts comply with internal SOPs and GCP requirements

- Close team working with internal or external functions such as Research & Development, Manufacturing, Quality, Regulatory Affairs and any expertise required to implement and oversee the study according to GCP, the Protocol and the requirements of the Management Team

- Work closely with Clinical Research Coordinator for clinical site & trial performance.

- Coordinate the development of specifications for ESPs in collaboration with stakeholders and ensure appropriate quality control of deliverables

- Contribute to the development of regulatory documents, responses to Health Authority, Regulatory and DSMB questions

- Oversee study approval processes for Health Authority, EC/IRB approvals for all study document as required

- Contribute to plan & organize Investigator meetings, clinical trial related training & review related material

- Oversee monitoring activities and conduct co-monitoring visits to ensure data quality

- Assists in medical monitoring of trial conduct & ensures that non-serious and serious adverse events are properly documented and reported

- Ensure adequate trial resources in personnel and material are available cross-functionally and escalate issues if needed

- Ensure study team members are timely informed, trained and updated on their role and responsibilities through-out the duration of the study

- Provide study specific direction to study team members and ensure that they are regularly updated on the study progress, challenges and risks through-out the duration of the study

- Address subject enrolment and retention issues, identify and implement actions to keep study on track

- Ensure proper study documentation is maintained and archived in the TMF

- Ensure timely follow up of agreed upon actions

- Resolve issues in a proactive and timely fashion and escalate unresolved issues and identified risks to Head of Clinical Development as appropriate

- Provide regular study status updates to Senior Management as needed , Ensure tracking of study budget including revisions and perform final reconciliation at trial close out

- Implement best practices and lessons learned and share outcome with the teams

- Oversee database lock activities to ensure timely data availability and coordinate study close out with stakeholders as needed

- Adhere to personal development plan and maintain training records to ensure appropriate level of competence in compliance with this job description including GCP and other compliances.

- Contribute to translational plan for cell & gene therapy products

- Contributes to SOPs and relevant medical writing responsibilities

- Contributes to scientific & medical liaison communications

Operating Network:

- Interface with R & D, Manufacturing, Quality, Regulatory and clinical development

- CRO personnel, clinical site personnel, investigators, data entry operators, supply chain logistics

Educational & Experience:

- MBBS or equivalent, preferably MD (Master degree) or equivalent university education/degree in medicine / allied medical field

- Minimum of 5 years relevant experience in clinical development and clinical trial management with minimum 2 years in industry. Oncology trial experience is mandatory.

- Demonstrated expertise in clinical research & development and project management (including risk management and contingency planning)

- GCP trained

Key Personal Attributes: Essential

- Demonstrated project management experience and leadership skills (e.g., leading project teams) working in cross-functional (matrix) and multicultural teams

- Experience in managing complex studies (e.g., large studies, difficult patient populations, involvement of many external service providers)

- Experience in executing a wide range of clinical trial activities (from initiation to clinical study report)

- Good understanding of clinical trial budget

- Knowledge of International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines and other relevant clinical trial regulations

- Ability and willingness to travel nationally & internationally

- Excellent communication skills in English; both verbal and written

- Ability to make executive presentations

- Team player, collaborative attitude

- Well read on treatment guidelines in oncology

Desirable skills:

- Experience in biopharma field

- Translational program experience

- Bio sample archiving

- Excellent interpersonal and networking skills

- Pro-active and problem-solving attitude, very strong prioritization skills

- Excellent planning and organizing skills

- Personal resilience, perseverance, energy and drive

- Proficiency in MS Office Suite (Word, Excel, PowerPoint)

- Fast learner, with a willingness to engage with scientific experts