Medical Director - Clinical Development
Proclinical is currently recruiting for a Medical Director of Clinical Development with a biotechnology company located in Boston, MA. Successful candidate will lead clinical development planning as well as the direction, planning, execution, and interpretation of clinical trials activities of novel exosome therapeutic compounds, in various indications through early development to global regulatory submissions.
- Lead Clinical Development Planning and demonstrate ownership of study designs and implementation in support of the overall product development plan, based on strong cross functional collaboration, medical and scientific principles, knowledge of compliance and regulatory requirements, markets, business operations, and emerging issues.
- Oversee therapeutic area project-related education of investigators, study site personnel, and study staff.
- Design and implement clinical trials, including writing medical protocols, creatively working to assess appropriate endpoints.
- Responsible for leading clinical study subteams, monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data.
- Present at scientific, medical and regulatory meetings globally.
- Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL's, and patient advocacy groups.
- Contribute to company's planned regulatory filings including authoring clinical sections for INDs, NDAs, and other related documents.
- Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds.
- Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders.
- Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives.
- Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards.
- May participate in or lead clinical development contributions to due diligence or other business development activity.
- Collaborate with Clinical Operations in identifying CRO's or other collaborations that enable models or apply expertise that is not available in-house.
- Collaborate with, monitor and report CRO-based study results to the project team and executive leadership.
- Participate in meetings and committees as part of potential partnerships.
- Establish collaborative and productive relationships with potential internal/external partners and relevant affiliates.
Skills and Requirements:
- MD or PhD with completion of a residency program strongly preferred, completion of a subspecialty fellowship is desirable.
- 5 years of pharmaceutical drug development experience required.
- Experience in solid tumors/blood cancers and/or immunology preferred.
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 James Stevens at (+1) 646-693-0610 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.
Proclinical Staffing is an equal opportunity employer.