Executive Director, Clinical Affairs, Paarl, South Africa 148 views0 applications

Job Summary & Responsibilities

The Executive Director, Clinical Affairs will work very closely with the Chief Medical Officer and will play a critical role in the organizational strategy, as well as the accomplishment of organizational goals, product development and operational implementation of the clinical trials.

This position oversees Clinical Operations employees and consultants (including Associate Director – Clinical Operations, Clinical Project Managers, Clinical Project Associates, Clinical Trial Assistants, Operations Coordinator and Administrative Assistant) and will work with the Chief Medical Officer to ensure that the clinical affairs team is resourced appropriately and processes and procedures support a high functioning team. Although we outsource some functions to CROs, strategic decisions and critical functions are retained within the company.

The Executive Director of Clinical Affairs will have overall responsibility for the broad spectrum of clinical activities including but not limited to, clinical processes and SOPs and ensuring that clinical programs are of high quality and are delivered according to plan.

Job Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

• Assist the Chief Medical Officer on all Clinical Affairs Department matters and act as back-up when designated.
• Contribute to the clinical strategy for IPM’s drug candidates in development. Develop effective clinical development plans for clinical candidates.
• Responsible for the development and management of Clinical Development Plans, as part of the overall Product Development Plan, which includes timelines, budget and resource requirements.
• Management of Clinical Affairs cross-functional teams and consultants (Clinical Operations, Social Behavior Science, Biometrics and Clinical Safety Teams).
• Plan, design and direct clinical trials. Ensure the efficient and effective progress of protocol development – specifying research objectives, participant recruitment and treatment allocations, study procedures and end points – from Phase I through IV.  Identify and select appropriate clinical investigators to perform studies.
• Define, together with the Head of Clinical Operations, project targets and time tables and assess resource requirements, both personnel and financial, to ensure feasibility of clinical development plans.
• Ensure that all clinical trials conform to internationally accepted standards of good clinical practice and good laboratory practice.
• Establish statistics and data management requirements for each clinical trial. Ensure adequate outsourcing to meet these requirements and track progress during the conduct of the trials.
• Identify needs for external support as needed. Oversee vendor selection and management.
• Oversee progress of ongoing clinical trials to ensure that IPM’s resources are being put to best use and that the project will meet all critical success factors; prepare materials for interim and formal project reviews.
• Help select, oversee and direct CROs and work effectively with partner organizations to conduct clinical trials in accordance with the clinical development plans, GCP/GLP, and applicable regulatory requirements.
• Build relationships and collaborations with investigators and key opinion leaders involved in trials.
• Collaborate with other functional areas and departments to meet company objectives.
• Support other company initiatives, as needed
• Any other responsibility as assigned.

Job Specifications

Candidates for this position should have the following education/experience and demonstrate mastery of the following knowledge, skills, and abilities:

Education/Experience

• Appropriate qualification from a tertiary institute with experience in any of a broad range of therapeutic categories, HIV prevention or therapeutics will be an advantage;
• Minimum of 15 years direct management and industry experience in designing and implementing clinical development programs from Phase 1 through Phase 4, ideally using external resources, with a strong understanding of the planning and management of clinical trials for new compounds.  Some experience conducting trials in the developing world desired.
• Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential.
• Experience and understanding of ICH, and GCP is required.
• Good knowledge of   regulatory and ICH/GCP guidelines is required;
• End-user computer efficiency, with proficiency in Microsoft Office products;
• Familiarity with HIV/AIDS and/or adolescent and young women and/or Africa medical settings is desired.

Knowledge, Skills and Abilities

• The ability to be a strategic thinker and a tactical implementer.
• Creative, constructive, responsive approaches to multiple expected and unanticipated challenges of rigorous, large-scale, multi-center and multi-cultural clinical research trials, especially in developing country and in community-based settings.
• Demonstrated ability to orchestrate complex relationships among research centre staff and stakeholders and to interact effectively with principal investigators, research centre staff, and colleagues.
• Cultural sensitivity.
• Detail-oriented while keeping the big picture and long-term goals in perspective.
• Leadership skills that include the ability to build effective project teams and ability to manage the clinical team (or part thereof) from a remote location.
• Excellent time management and organizational skills with the ability to manage multiple projects and delegate varied tasks with enthusiasm and prioritization of workload.
• Superior decision-making abilities, excellent judgment and integrity and ability to motivate and engage others.
• Highly motivated and team oriented, but also able to work independently, assessing priorities and competently handling a variety of activities with a high degree of accuracy in a deadline-driven environment.
• Strong self-management skills with a high level of initiative, creativity, and assertiveness.
• Effective and strong written and verbal communication skills.
• Results oriented, with a demonstrated ability to work in a fast-paced environment and meet deadlines with competing priorities.
• Ability and willingness to mentor Clinical Project Managers, Clinical Team Leaders and other team members.
• High level of confidentiality and professionalism required.
• A sense of humor, flexibility and humility.
• Flexible, adaptable, and tolerant of some ambiguity; eager to acquire new skills and knowledge; and capable of working well under pressure.
• A significant amount of travel to the developing world is required.

Terms and Conditions

This position is based in the Clinical Affairs department of the IPM office in Paarl, South Africa.   Job holder should expect fast paced working environment. International travel may be required. A valid driver’s license as well as own reliable transport is required.

The International Partnership for Microbicides, Inc. is an Equal Opportunity Employer.

This job description should not be construed to imply that these requirements are the only standards for the position.   Other duties will be assigned.   IPM has the right to revise this job description at any time.