The primary focus will be to lead and ensure execution of clinical development programs in Oncology. This position will be a key member of the leadership team and will help set, navigate and execute the clinical development strategy of the company. The successful candidate will need excellent strategic, execution, collaboration and communication skills, as well as an entrepreneurial approach, to work with and influence others. This is a unique opportunity to be a major contributor to the success of a well-positioned, well-financed, clinical ready biotechnology company.
JOB FUNCTIONS/RESPONSIBILITIES
- Develop clinical strategies and implementation plans, in partnership with both internal and external resources to achieve the company’s strategic and tactical goals/objectives.
- Lead a clinical development team with multiple clinical programs.
- Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results, including preparation of abstracts, presentations and manuscripts.
- Input into the regulatory strategy as well as contribute to, review or approve (as required) regulatory documents for submission to multiple regulatory agencies for the various clinical programs.
- Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders in support of clinical programs.
- Ensure appropriate management and oversight of clinical studies, in partnership with clinical operations leadership. Includes development of clinical study protocols, input into selection and management of external entities such as CROs and other vendors, input into site selection for studies, study management, medical monitoring, clinical study reports, Investigators’ brochures, Regulatory briefing documents, and clinical sections of Regulatory filings.
- Achieve established timelines and operate within budget.
- Work closely with the Business/Corporate Development team to search and evaluate new opportunities.
- Ensure adherence to good clinical practice.
- Supervisory responsibilities include department employee and performance management, hiring and career development.
QUALIFICATIONS
Education/Experience:
- MD with Board Certification preferred.
- 10 years minimum experience in a pharmaceutical and/or biotechnology industry.
- 5 years minimum proven management/leadership experience.
- A proven success record of leading new medicines through all stages of clinical development to approval, with substantial experience in rare disease drug development.
Knowledge, Skills and Abilities:
- The successful candidate will possess excellent communication skills and can articulate the Company’s clinical and regulatory strategies and progress to a wide audience, including senior management, the Board of Directors, Company employees and external stakeholders.
- Strategic thinker with proven ability to evaluate the strategic implications of development decisions.
- Must have excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company; must have outstanding executive presence.
- Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with FDA personnel is essential; experience in interactions with other health authorities a plus.
- Must have a results-oriented work ethic and a positive, “can-do” attitude and the highest personal values and ethical standards.
- Effective leadership, people management, communication skills and a team builder management style are essential; must be willing and able to be “hands on”.
- Strong track-record of recruiting and leading high-performing cross-functional teams that value collaboration including the ability to develop talent.
- Experience with, or strong knowledge of orphan or rare disease drug development preferred or experience or knowledge of hepatology drug development a plus.
- Experience in translational medicine, clinical pharmacology and early stage development a plus.
- Previous experience coordinating with commercial and marketing teams to support efforts, including medical expertise and collaboration to strengthen a successful product launch.
Please email CV and Cover Letter to jobs@tseworldwide.com