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.
- 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
- 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.
- 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 indepth 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.