VP Medical Affairs
Proclinical is currently recruiting for a Vice President of Medical Affairs with a clinical-stage biopharmaceutical company located in Durham, NC. Successful candidate will be responsible for setting medical affairs strategies and be accountable for management of all medical affairs initiatives spanning both office and field-based activities in support of product launch and marketed products.
- Build, grow and manage a high-functioning Medical Affairs organization ensuring that company practices are compliant with relevant regulations.
- Direct line management of Medical Affairs team; including MSLs, Medical Communications, Real World Evidence generation, Medical Information (Call Centers and information dissemination), and Medical Affairs Operations (IITs, CME and Grants).
- Partner with the VP's of Clinical Development to provide matrixed leadership for Clinical Development, Statistics, and Clinical Operations supporting Medical Affairs initiatives.
- Provide strategic input into the development plans supporting launch and commercialization.
- Drive creation and oversee execution of the following global strategic plans: Publication Plan, Key External Experts (KEE) Engagement Plan, Advisory Board Plan, Investigator-Initiated Research Plan, Continuing Medical Education and Grant Plan to optimize product profile (s) and build product awareness.
- Drive the creation of effective presentations and tools that can be adopted and/or adapted globally (MSL slide decks, training platform materials, etc).
- Provide Medical Affairs support of product access for patients through the planning and management of health outcomes and quality of life research (partnering with Clinical Operations and Clinical Development).
- Serve as a senior representative of Medical Affairs to interact with key internal stakeholders: Marketing, Sales Training, Commercial, Business Development, Clinical Research and Development, Regulatory, and Program Leadership.
- Provide Medical leadership to the Commercial Team to assist in the development and execution of compliant commercial activities.
- Provide Medical Affairs strategic input for the elaboration of the brand plan(s); ensure execution of the Medical Affairs Strategy in line with the Brand Strategy.
Skills and Requirements:
- MD or PharmD with 10+ years of experience within a corporate medical affairs function including direct management of a Medical Affairs staff.
- Drug launch experience is required.
- Medical specialization in oncology is preferred.
- Understanding of regulatory compliance framework within which Medical Affairs operates (GCP and ICH regulatory guidances, clinicaltrials.gov, PhRMA and OIG guidelines, and other applicable statutes, laws and regulatory guidance).
- Experience and sound knowledge in conducting clinical trials (Phase I-IV).
- Advanced scientific, technical reading, writing and editing skills.
- Ability to prioritize activities, manage multiple tasks within deadlines and act with minimal supervision in a complex and dynamic environment.
- Oversight of contract service providers and external consultants will be required. Supervisory responsibility of in-house employees will be required. Must possess strong management/leadership skills working in a matrix organization.
- Strong written and verbal communication skills; ability to present results clearly and concisely to external experts and stakeholders, and within the organization, including Board members.
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 Ella Jobson at (+1) 646-868-5142 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.