Senior Director Clinical Development

Proclinical is currently seeking a Senior Director of Clinical Development for a pharmaceutical company located in the Greater Bay Area. Successful candidate will be responsible for the clinical leadership of global clinical development plans and protocols to support new and existing programs.

Job Responsibilities:

• Providing leadership and medical input for clinical programs, clinical protocols in development, ongoing clinical trials, clinical study reports and regulatory documents.
• Collaborating closely with team members in clinical development, operations, biostatistics, regulatory, pharmacovigilance, early development, and other functions to facilitate the execution of quality clinical trials and programs.
• Serving as medical monitor on trials for products under development in Hematology/Oncology and make recommendations based on safety findings to team, as needed; collaborating closely with CRO and study investigators on clinical trial eligibility and subject and patient safety issues.
• Reviewing, interpreting, and approving safety and efficacy data in clinical study reports, regulatory documents and submissions.
• Providing strategic input on new product concepts, long-range strategic plans and life-cycle management opportunities.
• Engaging external experts to obtain scientific input and to integrate current clinical practice and guidelines into global clinical development plans.
• Building, maintaining, expanding and managing external relationships with outside collaborators and clinical investors to support the clinical development program.
• Serving as clinical resource for issues raised by a range of collaborators, investigators, consultants and corporate/investor contacts.

Skills and Requirements:

• MA/MS or PhD required.
• MD or DO is preferred.
• Board Eligibility/Certification in Hematology and/or Medical Oncology is preferred.
• 3+ years academic and/or pharmaceutical industry experience.
• Demonstrated expertise in Hematology/Oncology global clinical development.
• Excellent oral and written communication skills.
• Knowledge of GCP, Drug Safety, MedDRA safety coding and Pharmacovigilance processes.
• Values-based leadership evident in personal interactions at all levels of the company.
• Proactive and effective work style, with creative problem-solving skills.
• US licensure and/or clinical practice experience is preferred.
• Ability to travel; over short periods of time, travel can be up to 30-40%.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nicole Aganon at (+1) 347-293-1161 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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