Clinical Development Senior Director F/M

Overall Objectives and Purpose of the role

This role is within the Clinical & Medical Affairs team reporting to the Head of Clinical Development / CMO. You will be a core team member within a matrix organization of a fast growing biotech company in the immune-oncology space. 

It is a perfect opportunity for an oncologist, who is passionate about clinical development, and have hands-on experience in drug development, either in industry, academia or in a CRO. 

You will be acting as a program level physician, involved in the strategy, design, conduct, monitoring, data interpretation and reporting of phase I/II clinical trials of one or more immuno-oncology agents, ensuring that the clinical development plan of the program is set up and conducted with the highest ethical and safety standards and in compliance with Good Clinical Practice (GCP) and regulatory requirements.

Main responsibilities and key tasks

Clinical development strategy 

• Provides the strategic direction and clinical development plans (definition and updates).
• Is a permanent member of Core team, leader of the clinical sub-team and depending on the program, may also be a member of study team.
• Provide medical/clinical expertise to Core Team to support the development and Launch of the product.
• Assist the Program Leader for drawing up the project strategy, including the search of new indications.
• Is responsible for clinical input in both internal and regulatory project documents
• Contribute to the review of available data and competitive environment for the product(s). Maintain up to date awareness of all-important advances within a given disease area through scientific literature, attendance at critical meetings and relationships with Key Opinion Leaders (KOLs).  
• Establish and maintain communications with prominent clinical investigators in field of expertise. Liaise with internal and external medical community to follow developments within area of expertise.
• Set-up and manage Advisory Boards.
• Frequent involvement in Business Development activities. 
• Represent the company clinical perspective in meetings with partners. Involvement on due diligence activities.
• Contributor to portfolio decisions.

Develop clinical trial protocol

• Develop a well thought, and medically solid clinical trial synopsis aligned with the clinical development strategy.
• Develops medical content for protocol and amendments.
• Support clinical operations team to the selection of investigators/sites to run clinical trials.
• Support regulatory team for successful submission of protocol to regulatory authorities.

Medical monitoring of clinical trials

• Serve as a trial level physician and medical monitor for clinical studies.
• Leads dose-escalation meetings.
• Reviews emerging clinical data regularly. 
• Managing and oversee the medical monitoring teams of CROs. 
• Provide consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators. 
• Work in close collaboration with the pharmacovigilance team to ensure adequate overview of the safety signals in the ongoing trials.

Interpretation of clinical trials results and contribute to clinical development strategy

• Work in close collaboration with the data management and statistics team to ensure proper analysis of clinical trial results.
• Writing of medical section in investigator brochure and other regulatory documents.
• Contributing to writing clinical study report.
• Contributing to publications, data presentation at scientific meetings, and manuscript writing.

Experience and Qualifications

• Graduate of a recognized school of medicine with an M.D. degree or equivalent with more than 5 years’ experience pharma experience (including in big pharma) this time spent should not include consulting or academia and consulting or academia should not be most recent job.
• Board Certification, Eligibility, or fellowship training in Oncology is required.
• Must have experience in clinical strategy in developing molecules from with experience in early phase clinical studies especially with monoclonal antibodies.
• Demonstrated experience in clinical report writing and publishing.
• Established understanding of pharmacokinetic and pharmacodynamic activities, including biomarkers and pre-clinical studies.
• Should have a strong scientific understanding and the importance in clinical studies.
• Specialty training in Immuno-Oncology, Tumor Immunology, or Immunotherapy.

Competencies, Skills and Behaviors

Technical Competencies

• Experience in medical monitoring of phase I/II clinical studies in industry, CRO or academic setting.
• Experience in protocol writing and preparation of submission to regulatory authorities.  
• Experience in trial data analysis, interpretation, reporting and presentation (oral presentation, posters, publications).
• The applicant must be able to read, write and speak English, French language skills being an advantage.
• Experience in communication with FDA/EMA (e.g. cooperation on an industry sponsored phase 3 trial).
• Previous participation or coordination of advisory boards.
• Training in statistics or clinical trial methodology.

Additional Skills/ Behaviors

• Highly motivated, dynamic physicians with aspiration to evolve and develop in the clinical development space.
• Strong interpersonal, presentation, and excellent written and verbal communication skills.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Develops technical and/or business solutions to complex problems.
• Demonstrated ability in decision-making, influencing, leadership, and affecting change by using a collaborative approach.
• Results orientated work ethic and a positive, can-do attitude.
• Strong organizational and time management skills.
• Leads or manages the work of others by providing guidance to subordinates based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Works on abstract problems across functional areas of the business.
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
• Comfortable challenging the status quo and bringing forward innovative solutions
• Ability to build strong partnerships and drive role clarity across cross-functional teams as well as with external organizations.
• Highly motivated, self-driven and dependable.
• Willing and able to be “hands on” and willing to “roll-up sleeves” and delve into details as needed.
• Ensures budgets and schedules meet corporate requirements.
• Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.

NB: This job description is designed to describe a series of main tasks that may be encountered. It is not intended to be an exhaustive list of tasks and may be modified in consultation with the incumbent to reflect changes in the position or organization.

Innate Pharma believes in equal opportunities and welcomes all qualified applicants for employment without discrimination.

Submit your application at jobs@innate-pharma.com