Senior Clinical Development Director Oncology ( Early Development)

Key responsibilities:

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.

Your profile:

Essential:

• 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.

Desirable:

• Specialty training in Immuno-Oncology, Tumor Immunology, or Immunotherapy.

Competencies, Skills and Behaviors

Technical Competencies

Essential:

• 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.

Desirable:

• 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[1]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.