This is a company that develops therapeutics for cardiovascular diseases.
Title: Executive Director, Medical Affairs — JO-2203-5748
Therapeutic Area: Cardiovascular
The Executive Director leads and builds the Company’s Medical Affairs program. S/he is an accomplished leader with a proven track record in developing and managing all facets of a Medical Affairs organization. The Executive Director will shape the Company’s activities to support a product launch and will be responsible for building professional relationships with KOLs, payors, vendors, consultants, and advocacy/patient support groups. Additionally, s/he will generate clinical content, including abstracts, posters, and articles for publication, literature and clinical content review, and training for Medical Affairs
Essential Duties and Responsibilities
- Establish and lead the Medical Affairs organization at the Company. Provide direction and medical leadership for Medical Affairs and prepare for the product launch.
- Assist with building key relationships with KOLs, customers/vendors, consultants, and advocacy/patient support groups.
- Provide strategic and operational support as needed for the design and oversight of clinical trials to support the commercialization of the product.
- Provide support to the product program and lead in responding to requests for information, business development, and partnership interactions, as well as prepare for and support steering committee meetings.
- Follow Company policies, SOPs, guidelines, guidance, regulations, and statutes from regulatory authorities and governmental entities. Assist the quality function in creating/reviewing Medical Affairs SOPs in development.
- Assist the product program and lead in managing the scientific platform both strategically and tactically.
- Optimize the product through ideas to develop new scientific data, meta-analyses, and communications, and generate clinical content, including abstracts, posters, and articles for publication.
Qualifications (Education & Experience)
- Licensed and board-certified physician (e.g., MD/DO or equivalent degree) with 5 years of Medical Affairs experience or PhD, Pharm D, Physician’s Assistant, or Nurse Practitioner with at least 10 years of Medical Affairs experience.
- Minimum of 5-10 years of biopharmaceutical industry experience with a strong preference for Medical Affairs functional experience.
- Understanding of regulatory compliance framework within which Medical Affairs operates (GCP and ICH regulatory guidances, ICMJE, clinicaltrials.gov, PhRMA and OIG guidelines, and other applicable statutes, laws, and regulatory guidance.
- Experience and sound knowledge in conducting clinical trials (Phase lll-lV).
- Advanced scientific, technical reading, writing, and editing skills.
- Proficient in word-processing, spreadsheet, and slide creation skills.
- Ability to prioritize activities, manage multiple tasks within deadlines and act with minimal supervision in a complex and dynamic environment.
- Must possess strong management/leadership skills working in a matrix organization.
- Strong written and verbal communication skills, ability to present results clearly and concisely within the organization, including board members, and external stakeholders.
- Demonstrated agility and success in a dynamic company/business environment where change is frequent and rapid understanding and alignment is paramount.
- Strong desire to work as part of many cross-functional teams consisting of technical, scientific, administrative, manufacturing/operations, and commercial team members.
- Able to travel both within the US and internationally up to 60% of the time.
Since 2009, TriNet Pharma has evolved into one of healthcare’s largest and most respected agencies for recruiting and placing permanent and contract Medical Affairs, Clinical Affairs, Regulatory Affairs, and Medical Communications professionals in life sciences companies in the United States and around the world.