Vice President, Clinical Development
Our client is a biopharmaceutical company. They have asked them to assist them in a search for a Vice President, Clinical Development
The company is looking for an experienced Vice President of Clinical Development with the passion and creativity to develop great medicines for serious and life-threatening diseases. This individual will be responsible for leading the company’s clinical research efforts across all the non-oncology programs. The lead program in this portfolio is focused on patients hospitalized with COVID-19 ARDS.
Reporting into the Chief Medical officer, this person will be responsible for the development and execution of clinical research and development programs including the leadership of the pivotal trials and filing activities.
This position will serve as a key liaison between the company and clinical investigators, and establish credible relationships with opinion leaders, regulatory officials and other key stakeholders and partners.
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Plays a key role is designing and implementing the clinical development strategy and the overarching corporate strategy.
- Directs involvement in trial design of Phase I/II/III research trials targeting pulmonary and immunology indications.
- Directly supervises and monitors trial conduct.
- Works closely with all functions of the organization and external partners to manage trial logistics.
- Collaborates in developing global regulatory plans and plays a key role in regulatory meetings in partnership with regulatory affairs.
- Follows important developments and relevant trends in the scientific literature and develops/maintains contacts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development of study and overall program.
- Develops effective relationships with external providers.
- Develops clinical study protocols and associated clinical study documents in compliance with clinical development plans, GCP, and good medical practice.
- Participates in the selection of clinical investigators, providing guidance to investigators on a study.
- Potentially leads a clinical scientist in the future.
- Provides medical supervision for contract research organizations and protocol procedures.
- Provides medical and scientific input in review of clinical data, patient medical safety data, and laboratory values, maintaining an ongoing assessment of the safety profile, and efficacy data as appropriate.
- Provides medical surveillance on Serious Adverse Event (SAE) reporting, and follow-ups.
- Directs and oversees the overall strategy for clinical drug product development and collaborates with Regulatory personnel in IND, CTA, and NDA submission activities as well as submission of IND safety reports.
- Assists with due diligence of new scientific developments.
- Supports corporate partnering efforts and business development activities by providing medical expertise and participating in partnership committees/task groups.
- Ensures that operational activities are conducted in compliance with all pertinent regulatory or statutory requirements and in accordance with the scientific standards, ethical and professional values, management philosophy, and established priorities, policies, and practices of the Company.
- Leads the medical writing for the preparation of summarization of clinical trial data, including the preparation of study reports, integrated summaries, and clinical portions of package inserts and other product labeling.
- An MD or equivalent with prior training or experience in the pulmonary, immunology, rare diseases, or critical care/intensive care areas is required.
- Requires 5+ years of clinical and leadership experience in drug development.
- Experience with trials from Clinical PoC though NDA / BLA is strongly preferred.
- Global clinical development and filing experience are strongly preferred.
- Technical (Medical and Scientific) experience evaluating targets/agents for in-licensing or internal development is desirable.
- Experience as a team leader is highly desirable.
- Excellent interpersonal and public speaking skills are required for this high visibility position.
- Must have the demonstrated ability to work in a matrix environment with cross-functional teams.
- Must be based on the east coast and available for on-site meetings when appropriate.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.