What are the responsibilities and job description for the Medical Director (AD to ED) position at Precigen, Inc?
Reporting to the VP, Head of Medical Affairs, the Precigen Medical Director is a highly trained, office-based, scientific expert in gene therapy, who engages health care professionals and leaders in clinical, scientific, value-based care and research-based peer to peer scientific exchange around recurrent respiratory papillomatosis (RRP).
Primary responsibility of this position is to support the creation of PRGN-2012 launch strategy and to ensure the execution of it, in close collaboration with the key internal functions (commercialization, early development, clinical operations, legal, regulatory). Following regulatory and corporate guidelines, he/she will facilitate and build scientific relationships and collaborations with the Otolaryngology and Gene Therapy scientific communities.
This position interacts with local, regional, and national Key Opinion Leaders (KOLs) and health care practitioners (HCPs), as well as professional societies and patient advocacy groups. The Medical Director will need to be fully engaged with pertinent professional societies, as well as other value-based institutions and associations including clinics and centers that are involved with the treatment of recurrent respiratory papillomatosis (RRP) and centers that deliver gene therapy.
The Medical Director will be the Office based scientific expert regarding PRGN-2012, an off-the-shelf (OTS) AdenoVerse® gene therapy in patients with RRP. Additional duties involve the optimization of the lifecycle management of PRGN-2012 and the support of additional assets part of Precigen pipeline.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Functions as the primary medical point of contact for internal and external key stakeholders.
Maintains clinical and scientific, expertise in otolaryngology pathophysiology and gene therapy with specific focus in standards of care related to the treatment of RRP.
Engage in well informed, compliant, robust, and accurate scientific peer exchange around the Precigen pipeline, with KOLs.
Has a thorough understanding of the clinical protocols, clinical trials outcomes and related procedures.
Supports the development of the Medical Affairs launch strategy for PRGN2012
Is the primary responsible for the execution of the Medical Affairs strategy
Leads the launch excellence process in alignment with other key internal functions in the context of the commercialization team
Engages in medical & scientific exchange with the medical/scientific community including advisory boards.
Responsible for all clinical program requests and for unsolicited requests for information.
May collaborate with R&D Team to support sites and investigators participating in the company-sponsored clinical trials.
Supports and/or leads as needed Medical Information activities
Works collaboratively and compliantly with commercialization colleagues to assure product strategic imperatives are represented cross functionally
May serve as a resource for investigator sponsored trial (IST) proposals
Represents Precigen at medical meetings through Medical Affairs’ Scientific Booth coverage and other related activities.
Attends congresses as appropriate and develop meaningful internal reports of the congresses covered.
Adheres to corporate SOPs and ensure vigilant compliance with relevant legal and regulatory guidelines governing scientific interactions with physicians and healthcare professionals across all activities, including those related to clinical trials, scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information.
Consistently demonstrate a high standard of excellence in the management of assigned territory while also contributing to the success of colleagues and the MSL team.
Be solidly versed in the clinical data such that the full range of innovative science, clinical, outcome, economic and value aspects of Precigen’ s products can be appreciated by the healthcare practitioner, formulary member or payer.
Provides medical support, clinical input, and/or training for internal teams as requested.
Supports the optimization of the LCM of PRGN2012 and the further development of Precigen pipeline as needed.
PREFERRED QUALIFICATIONS:
An advanced degree (e.g., PharmD, PhD, MD,) is required.
- Big Pharma experience preferred
A minimum of 3 years previous similar experience necessary with a minimum of 2 years in one of the following therapeutic areas: rare disease, hematology, oncology (and/or immunology)
- Cell and Gene Therapy experience strongly preferred.
Prior product launch experience required.
Exhibits the highest level of scientific, business, and clinical acumen with excellent communication and networking skills.
The ability to interpret and present scientific data to engage KOLs.
Working knowledge of standards of care for RRP is desirable.
Excellent written and oral presentation skills.
Ability to travel frequently (25-30%) with overnight stays (e.g., KOL meetings, site locations, internal meetings, medical meetings and congresses, training).
