Associate Director, Clinical Development
101 Park Drive, Milton Park, Oxfordshire, OX14 4RY, UK, Conshohocken, Pennsylvania, United States, 2275 Research Boulevard, suite 500, MD 20850
The Associated Director (AD) Clinical Development will work with stakeholders across the organization to design and monitor strategically aligned, efficient clinical trials that meet ethical, scientific, safety, regulatory, and commercial objectives.
The AD Clinical Development will serve as the Medical Monitor for their assigned trials. In this regard, they will be accountable for ensuring the safety of all study participants and compliance with the study protocol. They will also be accountable to ensure all relevant information is incorporated into the narrative for each Serious Adverse Event. This will include working collaboratively with the Pharmacovigilance team to identify and communicate emergent safety signals and trends to the clinical project teams and senior management.
As the Medical Monitor for their assigned trials, they will participate in all stages of the clinical trial development process including (but not limited to): feasibility assessments, protocol design, case report form design, investigational site selection, review of study/bid proposals, ongoing medical support and management of adverse events and serious adverse events, and clinical study reports.
The AD Clinical Development will also be responsible for analysing and interpreting clinical data emerging from their assigned clinical trials with a goal to identify trends and signals in safety and efficacy and to translate this information effectively to guide the successful conduct of the clinical study as it relates to all of the key primary and secondary objectives (e.g., determining recommended dose; appropriate toxicity management guidelines; identification of patients subsets most likely to responds/benefit from treatment).
The AD Clinical Development is be expected to maintain knowledge of relevant regulations and guidelines (e.g., ICH, GCP) and disseminate this to their clinical study teams (as applicable) and work to support the Clinical Department in establishing Best Practices for the department, including the development of standard operating procedures and company processes while ensuring the highest ethical standards in the conduct of clinical trials are employed. They will be tasked to provide therapeutic area (TA) support at multiple levels within the company, including the provision of TA-relevant internal training.
- Ensure adherence to pertinent regulatory requirements (e.g., GCP) and to departmental policies, practices and procedures.
- Must ensure knowledge is kept up to date by reading/training on relevant SOP’s assigned to role
- Maintaining knowledge and awareness of GCP guidelines by maintaining GCP certification provided by Immunocore
- Ensure all work performed on assigned studies meets all GCP/ICH Guidelines and is Inspection Ready
- Serve as the Medical Monitor on clinical trials ensuring the safety of study participants, adherence to the study protocol, scientific rigor, and compliance with all applicable Health Authority regulations as well as design and implement safety monitoring plans for such clinical trials
- Routinely review study data on an ongoing basis on all assigned study(ies) to ensure consistency and validity from a clinical perspective
- This includes (but is not limited to) reviewing primary and secondary safety, pharmacokinetic, pharmacodynamic, and efficacy endpoints for consistency, potential signals (of interest or concern), and trends
- This also requires working in concert with data management and clinical operations to resolve data discrepancies (e.g., in-stream data review, coding review)
- This includes regular review of protocol deviations for appropriate classification, corrective action, and escalation (if need).
- Capable of analysing and interpreting data, identifying trends and signals, and synthesizing key learnings to impact subsequent phases of clinical development as well as to shape the translational medicine plans so they are complementary to the clinical development plans
- Able to draft content for abstracts and posters based on trial data from assigned clinical trials ensuring a scientifically rigorous, coherent, and consistent approach to publications
- Lead and oversee the drafting of protocol synopses, protocols, protocol amendments, and clinical study reports
- 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
- Support site selection and site activation activities including contacting investigators to discuss potential interest in assigned study, developing slides for site initiation visits (SIV), and performing SIVs as needed as well as Contributing to the development of patient recruitment and retention strategies
- Identify and communicate study issues that will impact budget, resources and timelines
- Able to interact directly with investigators and other key site staff and be able to handle a broad range of issues including (but not limited to) overall site performance, study conduct and compliance, clinical queries from study sites, scientific engagement, and investigator relationships
- Able to cultivate relationships with thought leaders and investigators, while gathering input on disease areas and potential future design of clinical programs
- Able to lead and guide decision making within the Clinical Study Team
- In collaboration with the Clinical Project Team Members, able to contribute in generating appropriate responses to study-related questions from Institutional Review Board/Ethic Committee and Health Authority
- Provide clinical support to medical affairs and commercial colleagues by providing relevant information about ongoing clinical programs (including emerging safety and efficacy signals) and top-line study results.
- Execute and/or deliver trial specific and/or therapeutic training as required
- Maintain knowledge of trends and changes of importance in the medical management of indications relevant to company projects.
- Review of CRO data listings, relevant lab data and SAEs and work with internal teams regarding follow-up
- Review lab alerts and SAEs and communicate with internal teams regarding follow-up
- Monthly review of protocol deviations
- CRF review
- Participation in DBL (final listing review, review of blinded TLFs (if applicable), review protocol deviations, participate in all DBL meetings)
- CSR writing (review final TLFs, work with medical writer to review & revise CSR document, draft discussion and conclusions, participate in comment resolution meetings)
- Attend and present at Investigator Meetings or other study specific meetings on the therapeutic area, status of the clinical trial, project and/or asset, as required
- Represent Clinical Development in cross-functional initiatives (e.g., start-up, continued process improvements with CROs).
- Contribute to the development and/or participate in the review of Immunocore SOPs, Work Instructions and team policies with a primary focus on clinical development
- Contribute to preparation of investigator newsletters or email newsflashes.
- Support the internal and external project teams with audits/inspection readiness and activities, resolution of audit/inspection findings and contribution to CAPAs as required.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
This role does not have supervisory duties associated with it.
Experience & knowledge
- Working knowledge of GCP, ICH, GDP and relevant CFRs is required; familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus
- 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.
- Experience must include conduct of early phase clinical studies
- Must demonstrate clear understanding of how to safeguard patient safety during the conduct of clinical studies with specific emphasis on the following:
- Strong understanding of clinical medicine, disease processes, and patient management relevant to the therapeutic areas of interest to Immunocore and in the context of clinical trial management
- Ability to review and provide input into Serious Adverse Event reports
- Review lab data and adverse events looking for trends
- Contribute to the design of clinical protocols that incorporate appropriate monitoring and risk mitigation for study subjects
- Strong understanding of how translational medicine supports the drug development process
- Must understand how to incorporate biomarkers into early phase studies
- Experience must include how to analyse and interpret biomarker data from early phase studies
- Experience incorporating a diagnostic into late phase programs is a plus
- Experience creating and maintaining healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where required
- Ability to work effectively in a matrixed environment with relevant teams such as clinical operations, statistics, regulatory, pharmacovigilance and translational medicine.
- Excellent written and oral communication including presentation skills and experience delivering effective presentations on both technical and nontechnical subjects.
- Ability to work effectively within clinical study team meetings with other internal cross-functional team members and vendors, as required
- Ability and willingness to represent clinical development voice at cross-functional team meetings
- Able to integrate complex clinical and translational data
- Able to lead clinical teams
- Able to listen to and integrate input from cross-functional team and then make clear decisions
- Able to take part in and contribute to interactions with global health authorities in support of IND/First in Human stage programs (required) and in support of BLA/NDA/MAA
- Strong interpersonal skills with the ability to drive and influence decision-making
- Capable of learning from exposure to and successfully working with multiple functions within biopharmaceutical drug development arena
- Able to work closely and collaboratively with senior leaders from across the company as necessary
- Deep understanding of, and experience with, developing immunotherapies in oncology
- Experience working with CROs including providing oversight
- Able to gain experience leading interactions with global health authorities in support of IND/First in Human stage programs (required) and in support of BLA/NDA/MAA
- Communication Proficiency in local language.
- Must work with professional discretion and confidentiality
- Able to prioritize in the face of multiple competing priorities
- Able to manage at least 2-3 Clinical Trials of low to moderate complexity
- Self-motivated; demonstrated success in delivering assigned tasks according to timelines
- Ability to work independently and think outside the box and problem-solve challenges of low to moderate complexity
- Able to anticipate challenges and devise strategies for success
- Result and deadline orientated
- Effective at time management.
- Collaboration Skills with ability to work as part of a diverse team
- Excellent presentation skills
- Personal Effectiveness/Credibility.
Education & qualifications
- Medical Degree (M.D., DO or equivalent).
- Demonstrated ability to critically evaluate medical/scientific information.
At least 1-2 years of relevant experience in clinical drug development across academia or pharmaceutical industry
- A thorough understanding of what is required to function as a medical monitor in a biotechnology/ pharmaceutical company
- Strong understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements.
- Training and experience working in Immunotherapy, Oncology and/or Infectious Diseases is preferred
- Documented work experience/knowledge of statistics.
- Demonstrated computer skills; proven functional knowledge of Microsoft Office, data review tools (e.g., J-Review, Spotfire, JMP-Clinical), and ability to develop proficiency in relevant Immunocore software systems and programs
IMMUNOCORE VALUES – ALL STAFF
- We lead with science to benefit patients
- We are entrepreneurial
- We value diversity to drive innovation
- We respect each other and act with integrity
- We do the right thing
WORK AUTHORIZATION/SECURITY CLEARANCE (IF APPLICABLE)
Work authorization and a valid passport is required for this role.
Immunocore LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
This job operates in a professional office environment and external environment. This role uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
This is a sedentary role working for prolonged periods at a computer, some filing and traveling to/from locations. This would require the ability to lift files and some heavy items (such as but not limited to suitcases, laptop bags), open filing cabinets and bend or stand as necessary. This role must be able to navigate various department within the office space.
POSITION TYPE AND EXPECTED HOURS OF WORK / TRAVEL
This is a full-time position.
Office hours are weekdays during core business hours. Occasional overtime may be required based on work priorities, outside of general office hours.
Approximately 10 - 40 % travel overall, frequency dependent on phase of study and requires flexibility. Travel includes conferences, Investigator meetings and site-initiation visits