National Senior Director, Field Medical Affairs

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.   Who we are   We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.   We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.   We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.   We maintain a start-up culture of camaraderie and leadership by example, regardless of title.   We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.   Notice to staffing firms   Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

Responsibilities

Establish, grow, and lead the national field-based MSL team, including defining operational frameworks, best practices, and standard operating procedures

Ensure high standards of scientific and operational excellence through effective recruitment, training, mentorship, and performance management

Translate overarching medical strategy into clear, actionable goals and measurable field medical initiatives

Lead the identification and strategic engagement of key thought leaders and external experts in alignment with the medical strategy

Oversee field-based support of clinical trials, including site education, patient recruitment, and investigator engagement

Represent the organization at scientific conferences and participate in advisory boards and other scientific forums

Build MSL team infrastructure for compliant scientific insight and data collection, MSL training and SOPs; direct the team on CRM operations

Oversee, MSL scientific engagements & activities that support compliant interactions with KOLs/HCPs and key stakeholders and guide the collection and dissemination of actionable insights that inform internal strategies relevant to the medical and clinical development landscape

Work within the team to bring alignment & collaboration across products, disease states and indications

Support MA by engaging with cross functional teams on business planning, special projects & strategic imperatives as assigned, including working with cross functional partners to optimally lead and support congress planning & execution

Direct MSL activities to ensure the highest ethical standards & compliance with all applicable laws, regulations, industry codes, policies, SOPs, OIG, FDA, PharMA guidelines & the Orca Bio Code of Conduct

Maintain scientific and clinical expertise through continuous education and attendance at key meetings and symposia

Collaborate with in-house teams on publications, training, internal initiatives, and development of medical resources

Experience Requirements

Advanced scientific degree required, doctorate level clinical/medical degree (MD, PharmD, PhD)

8+ years’ experience within Medical Affairs, experience working as an MSL and at least 3 years of experience managing field-based MSL teams

This leadership position requires excellent communication and interpersonal skills, motivation, initiative, mentoring, strategic thinking, problem solving, planning, & organizational skills

Strong understanding of US pharma rules and regulations, particularly as they apply to MSL activities; ability to develop, coach & oversee a highly compliant MSL function

Experience in team management, developing, reporting, & tracking MSL performance

Experience with managing departmental projects & resources

Experience with managing & developing relationships with key opinion leaders (KOLs)/health care professional (HCPs)

Preferred:

Cell and/or gene therapy experience

Experience working in a small biotech company or start-up environment

Demonstrated success in field medical launch planning and execution

Reporting Structure & Authority:

• Direct reports include: Field based Medical Science Liaison Team
• Direct Supervisory responsibilities including decision-making authority
• recruitment, training, mentorship, and performance management

Travel Requirements

Domestic travel will be required from time to time as needed (approximately 40-50%).